National Advisory Board on Medical Rehabilitation Research (NABMRR)
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
May 6-7, 2019
Robyn Watson Ellerbe
Arthur W. English
Edelle C. Field-Fote
Kathleen M. Friel
Gregory E. Hicks
Thubi H. A. Kolobe
Kenton R. Kaufman
Craig M. McDonald
David J. Reinkensmeyer
Ex-Officio Members Present:
Alison Cernich, NICHD
Daofen Chen, NINDS
Lyndon Joseph, NIA
Ralph Nitkin, NICHD
Ex-Officio Members Absent:
Jerome L. Fleg, NHLBI
Mary F. Lovley, OSERS
Lana Shekim, NIDCD
NICHD Staff and Visitors:
Tim Brindle, VA
Joseph Bonner, NICHD
Scott Campbell, AOTA
Eric Carbone, CSC
Theresa Cruz, NICHD
Shawnise Durham, NICHD
Jacklyn Ebiasah, NIBIB
Valerie Florance, NLM
Jennifer Jackson, NICHD
Lyn Jakeman, NINDS
Lisa Kaeser, NICHD
Naomi Kleitman, CHN Fdn
Helene Langevin, NCCIH
Michael Lipp, CMMI
Susan Marden, NICHD
Clay Mash, NICHD
Missy Morrow, Mayo Clin
Christine Rogers, NICJD
Merav Sabri, NCCIH
Karen Siegal, VA
JoAnn Thierry, CDC
Lois Tully, NINR
Chair Dr. Lanig called the meeting to order at 9:00 a.m. Members of the Board introduced themselves, followed by brief introductions from NIH staff and other visitors. Minutes from the previous meeting of December 2018 were unanimously approved. The Board will meet December 2–3, 2019; May 4–5, 2020; and December 7-8, 2020.
NICHD Director’s Report
Diana Bianchi, M.D., Director, NICHD
Dr. Bianchi testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. The marked-up bill included $41.1 billion for NIH (an increase of $2 billion), $1.58 billion for NICHD (an increase of $80 million over Fiscal Year [FY] 2019), and $12.6 million for the Gabriella Miller Kids First Pediatric Research Program.
NICHD Strategic Planning Process
The NICHD strategic plan aims to identify where NICHD should lead, where it should partner and participate, and where it should make future investments in research, training, and infrastructure. The process is transparent and includes stakeholder participation.
Input has been sought from a variety of internal and external sources, and decisions have been informed by evidence from portfolio analyses and other strategic and scientific plans. Themes have been drafted and released for public comment. Certain concepts were “woven” into the strategic plan: The “warps,” or lengthwise threads, correspond to specific scientific priority areas, while the “wefts,” or threads that run crosswise across the entire fabric, refer to concepts embedded in all of the priority areas. These crosscutting concepts include Global Health, Health Disparities, Infectious Diseases, Nutrition, Prevention, and Inclusion of NICHD Populations.
The six strategic plan themes that have been proposed in the Request for Information (RFI) are: (1) Understanding Early Human Development; (2) Setting the Foundation for a Healthy Pregnancy and Lifelong Wellness; (3) Promoting Gynecological, Andrological, and Reproductive Health; (4) Identifying Sensitive Time Periods to Optimize Health Interventions; (5) Improving Health During the Transition from Adolescence to Adulthood; and (6) Ensuring Safe and Effective Therapeutics and Devices. NICHD received 924 responses to the RFI, and the feedback is being used to refine and clarify the themes.
Next steps involve collapsing all of the themes and information into one document with clearly articulated priorities. Training needs, especially in gaps or new areas, will be identified. New mission and vision statements for NICHD have been developed and will be publicly shared after NICHD Advisory Council approval. The goal is to publish a plan by September 2019.
Updates on Trans-NIH and NICHD Initiatives
NIH HEAL (Helping to End Addiction Long-termSM) Initiative. This initiative, launched in April 2018, is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis by bolstering research in enhanced pain management and improved treatments for opioid addiction. NIH funding for research on opioid misuse/addiction and pain was $1.1 billion in FY 2018, made possible by targeted funding from Congress. The NIH HEAL Initiative programs include the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) program, in which clinical trials look at medical treatments and non-pharmacological approaches for infants with opioid withdrawal; a back-pain consortium; studies designed to integrate evidence-based pain management into healthcare systems; biomarker discovery and validation for pain conditions; and networks and trials to evaluate therapies for a broad array of pain conditions. NICHD and NCMRR signed on to 23 FY 2019 HEAL funding opportunity announcements (FOAs).
Trans-NIH Pediatric Research Consortium (N-PeRC). This consortium was formed to harmonize the pediatric research efforts across 25 of the 27 NIH institutes and centers (ICs) by coordinating efforts and identifying gaps and areas of collaboration. The largest investments come from NICHD, National Heart, Lung, and Blood Institute (NHLBI), National Institute for General Medical Sciences (NIGMS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and National Institute of Mental Health (NIMH). NICHD invested about $40 million in FY 2018. Areas of interest include pediatric drugs and devices, development of a data-sharing site for pediatric researchers, finding ways to grow the pediatric workforce, and the transition from adolescence to adulthood. N-PeRC also works to enhance communication with research advocacy organizations and encourage senior pediatric researchers to serve on review panels.
Data and Specimen Hub (DASH). This hub is a centralized resource where researchers can store de-identified data and access data and associated biospecimens from NICHD-supported studies. DASH is not a biorepository, but it manages requests for access to biospecimens associated with DASH data collections. DASH currently has 133 studies on 35 different topics. There have been 136 data requests and 15 publications from the secondary use of the DASH data.
Local Collaborations. Dr. Bianchi reported on her recent visit to local research hospitals (Howard University Hospital, Inova Fairfax Hospital, and the Children’s National Research & Innovation Campus) to explore potential partnerships that would bring NIH’s expertise to the community and allow NIH to address clinical research in areas that are not available at the Clinical Center, such as neonatal research. The possibility of partnering with Children’s National in the area of pediatric device research would be of interest to NCMRR.
Global Disparity Research. Dr. Bianchi reported on her trip to Kenya in February 2019 to visit NIH-supported research sites. Current sites focus primarily on infectious diseases, contraception, and maternal and child health, but there was considerable discussion of global disability research.
New Institute and Center Directors
Debra L. Tucci, M.D., M.S., M.B.A., will become the director for the National Institute on Deafness and Other Communication Disorders (NIDCD) in September 2019.
Helene M. Langevin, M.D., took over as the director of the National Center for Complementary and Integrative Health (NCCIH) in November 2018.
Dr. Bianchi pointed out that now 10 of the 27 NIH institute directors are women.
Elizabeth Baden, Ph.D., recently took over as chief of staff to the NICHD director, a newly created position that has already proven to be essential.
The searches for a new NICHD deputy director and for an executive officer are in the final stages. NICHD is also looking to hire Extramural Branch Chiefs in Pregnancy and Perinatology, Obstetric and Pediatric Pharmacology and Therapeutics, and Child Development and Behavior, as well as medical and program officers in the Division of Extramural Research.
A Board member asked who was responsible for cleaning the DASH data: NIH or the investigator. Dr. Cernich said the policies for supplying the data are on the DASH website. The researcher is responsible for the data quality assurance processes. Access to biospecimens requires participant consent, so studies that lack consent for future use of specimens are not listed. Dr. Bianchi added that there will be more clarity about ownership of the samples. The DASH process began because NICHD was paying to store millions of unusable samples.
A Board member asked whether ensuring collaborations is a trend across NIH. Dr. Bianchi said that there have been more trans-NIH projects under Dr. Collins’s leadership. She emphasized the importance of wide NICHD presence at meetings and activities to ensure that NICHD populations are not forgotten nor overlooked.
A Board member asked about NIH inclusion of underrepresented groups in research. Dr. Bianchi cited NICHD’s work on maternal mortality, which disproportionally affects black women; the All of Us Research Program, which has successfully enrolled a large percentage of underrepresented minority groups; partnering with the National Institute on Minority Health and Health Disparities; and NICHD’s own Office of Health Equity.
Funding Opportunities: NCMRR
Alison Cernich, Ph.D., Director, NCMRR
Dr. Cernich highlighted three NCMRR published research announcements:
NOT-HD-19-006: Request for Information: Research Plan on Rehabilitation
NIH requests feedback on the community’s perception of progress toward achieving the priorities in the plan, potential priorities or areas of research to consider in the update of the plan, current priorities that should be retained and continued, emerging areas of science that will affect the plan, and potential focus areas for concentrated work in medical rehabilitation. Comments should be sent to Rehabilitation1@mail.nih.gov.
RFA-HD-20-005: Research Project Grants in Pediatric Rehabilitation (R01 Clinical Trial Optional)
Applications are invited for research project grants addressing the rehabilitation needs of children with chronic physical disabilities. Available funding is $2 million for up to four awards (dependent on merit, funds available, and responsiveness). The project period is 5 years, and up to $499,999 in direct costs per year.
RFA-HD-20-004: Medical Rehabilitation Research Resource (P2C Clinical Trial Optional)
The goal of this effort is to create a national network of research centers that provide access to collateral expertise in biomedical, behavioral, engineering, and/or psychosocial fields that are particularly relevant to medical rehabilitation research and the needs of people with chronic physical disabilities. Other NIH components (National Institute of Neurological Disorders and Stroke [NINDS], National Institute of Biomedical Imaging and Bioengineering [NIBIB], NIDCD, National Institute of Nursing Research [NINR], and NCCIH) have joined NICHD to support this initiative. Available funding is $6,950,000 for up to six awards (dependent on merit, funds available, and relevance to participating NIH ICs). The project period is 5 years, with $750,000 in direct costs and an option for up to $250,000 for the coordinating centers per year. The NIH is particularly interested in the following high-priority areas: pediatric rehabilitation; personalized medicine approaches; family, caregiver, and community support; implementation and dissemination research; clinical trial design; strategies to explore and validate combination therapies; and, technology to track real-world outcomes. Additional areas may be proposed, provided they can be justified as unique, state-of-the-art, teachable, and specifically relate to the 2016 NIH Research Plan on Rehabilitation Research
A Board member asked about a proposed research infrastructure center collaboration with other institutions. Dr. Nitkin said it was permissible as long as the collaboration complements resources of the applicant organization and can be justified as cost-effective. Dr. Cernich added that investigators must outline the structure for coordinating all the activities.
A Board member asked about potential renewal of the pediatric rehabilitation research initiative. Dr. Cernich said that that would be decided after 3 years. The current Request for Application (RFA) is for a single cycle, because the money cannot be held over to a new fiscal year. She clarified that the funding is $2 million per year in direct costs for up to four awards.
Centers for Medicare & Medicaid Services (CMS) Policies to Promote Research and Evidence Generation
Susan Miller, M.D., Senior Medical Officer, CMS
Michael Lipp, M.D., Senior Medical Officer, Center for Medicare & Medicaid Innovation (CMMI)
Dr. Miller discussed how Medicare works to encourage innovative technology. She encouraged investigators to read the Innovators’ Guide to Navigating Medicare and distributed a reference sheet with contact information for the various processes described below.
Medicare can cover only technologies that are in a congressionally defined benefit category and not statutorily prohibited. The technology must be “reasonable and necessary” for the Medicare population. There are no statutory or regulatory guidelines for “reasonable and necessary,” so there is no checklist to determine whether a technology is covered. Medicare usually requires U.S. Food and Drug Administration (FDA) approval of the technology for at least one indication. But FDA approval does not automatically guarantee coverage, because Congress has defined the missions of Medicare (reasonable and necessary) and the FDA (safe and effective) differently.
The traditional pathway to Medicare coverage for an item or technology is the Medicare coverage determination process. In general, Medicare considers items or services to be reasonable or necessary if they improve the health outcomes of the patient population. The medical benefits and clinical utility of proposed items or services must be proven to be at least as effective in the Medicare population as what is currently available. The evidence must be sufficient to establish that the technology will provide a clinically meaningful or important health outcome for Medicare patients, such as improving patient functions by providing better ambulation, improving activities of daily living, or reducing pain or the need for medications.
Dr. Miller described other Medicare processes for approving innovative technologies:
- Coverage with evidence development is a process that is used when the evidence about an innovative technology is not quite enough to show it is useful to the Medicare population. In these cases, approval for coverage can be given if CMS approves the clinical trial. CMS may provide requirements for the clinical trial. Coverage approved in this category could include both the technology and the routine care involved.
- The Medicare clinical trial policy allows Medicare to cover routine services provided in qualifying clinical trials. For example, for a trial requiring physical therapy, Medicare would cover the routine physical therapy costs and any complications that might arise but not the investigational device itself. Studies funded by NIH, the Centers for Disease Control and Prevention, and the Department of Defense (DOD) receive strong consideration under this process.
- Investigational device exemptions (IDEs) also provide flexibility for Medicare coverage. For FDA Category B IDEs, where the device has an incremental risk that has not been studied but a previous similar device has been shown to be safe, Medicare can cover the device and the routine costs. For Category A IDEs, where there is a question about the absolute risk of the device, Medicare will cover only routine costs of the use of the device. Obtaining the FDA exemption does not make Medicare coverage automatic.
- The FDA–CMS Parallel Review Program allows investigators to talk to the FDA and CMS concurrently, which can save time and money by allowing investigators to more quickly determine what changes would be required by both entities. Investigators are advised to enter the Parallel Review Program no later than the pivotal clinical design stage.
- Application for new technology add-on payment is a process for add-on payments for expensive new technologies that might fit under the diagnostic-related group (DRG). Investigators can apply for a new technology add-on payment for inpatient or outpatient procedures or devices that are new, are expensive relative to the DRG, and represent a substantial improvement in the clinical outcome.
Dr. Lipp said that CMMI is under the CMS umbrella but is provides a testing ground for new payment and service delivery models, which can be expanded if they are found to reduce cost and/or improve quality of care. The focus is moving from fee-for-service to value-based care.
Dr. Lipp described some of the models at CMMI:
- The Comprehensive Primary Care initiative is an extension of the Comprehensive Primary Care Plus model for smaller primary care practices that want to move into value-based care. One arm of this model includes patients with serious illnesses. Providers get more flexibility to innovate and contract commensurate with the level of risk they assume.
- The Patient Care Models Group is working on the Bundled Payments for Care Improvement Advanced (BPCI Advanced) model. BPCI Advanced focuses mainly on bundles of care revolving around hospital admissions, linking payments for the multiple services that patients receive during an episode of care (e.g., testing bundles for episodes of care of patients with cancer who are undergoing chemotherapy, to allow providers to share in the upside if costs are reduced under that bundle).
- The State Innovation Models group partners with states to achieve better quality of care and lower costs. A Prevention and Population Health group is working on ambulance payments, which are currently predicated on bringing patients to the emergency department; the model looks at whether there is a better site of care with a payment structure that reflects what is most appropriate for the patient.
CMMI has seen a variety of trends with Medicare Advantage and fee for service for innovations in rehabilitation and post-acute care. For example, usage days in skilled nursing facilities have continued to go down. But in some models, provider groups that take on total cost of care have found opportunities in the post-acute space to innovate and improve patient care. Providers also see innovative opportunities in the transition from the hospital to the rehabilitation facility to the home. Dr. Lipp said that providers who are accountable for total cost of care and improving quality must have the tools and flexibility to succeed and innovate freely.
Dr. Nitkin noted that rehabilitation often supports people with chronic conditions and, for these populations, even maintaining function (rather than functional improvement) and avoiding secondary conditions and downward spirals could be a big victory. Health maintenance represents a tremendous and unappreciated cost saving. He suggested that CMMI should also take into account the value of health maintenance and patient support. Dr. Lipp agreed that getting risk adjustment right is very important.
A Board member suggested addressing health access equity by expanding the successful CMMI primary-care model to patients with disabilities. Once patients complete rehabilitation and are back in the community, they often lack access to primary care. Are there are models for these individuals? Dr. Lipp said there are no data on how the models affect patients with disabilities. Dr. Miller said Congress passed telemedicine laws that allow for payment only for certain providers, which might not include physical therapists, so there is no incentive in the community to provide telemedicine in that manner. The Board member asked about a role for clinical researchers to provide data showing that proper access to care (e.g., telephone access to therapists) decreases the burden of care, including the caregiver burden, and thus improves functional outcomes. Dr. Lipp said that telemedicine is only one part of improving access for patients. Other groups are working on innovations (e.g., house calls, high-risk clinics for patients with chronic conditions) to align provider incentives with patient needs.
Dr. Miller said investigators designing studies to lessen the caregiver burden should come to Medicare and talk about the right outcome measures. Although important, reduction of the caregiver burden cannot usually be used as an outcome measure for Medicare beneficiaries.
A Board member said a part of burden of care is paying for home healthcare. Optimizing functional independence in the home could decrease the number of paid home health care hours. Dr. Miller said Medicare generally does not consider money or cost-effectiveness; it looks at health outcomes that are important to the patient.
A Board member noted that acute spinal cord injury (SCI) requires considerable rehabilitation and education, yet inpatient time for this rehabilitation has steadily decreased. Patients must leave the hospital too early and are often soon readmitted. Dr. Lipp said in population-based models, providers who are totally accountable would be incentivized to avoid such negative outcomes. The Board member noted that patients must be discharged when their coverage is cut off. Dr. Miller acknowledged that too-short stays are a problem. For inpatient rehabilitation, Medicare requires the hospital to document that the patient keeps making improvements. For outpatient skilled care rehabilitation, both improvement and maintenance must be documented. Facilities must carefully document what Medicare requires so the patient’s stay can be appropriate.
Board member asked whether Medicare consults outside experts to reframe the conversation in problem areas, such as too-short hospital stays. Dr. Miller said groups and organizations routinely come to Medicare to discuss these problems and emphasized the importance of bringing real-world problems to CMS’s attention. Dr. Lipp said that organizations that take on full risk need to internalize expertise in a way that improves care. Dr. Miller added that if the community feels that access to care could be a pertinent measure of rehabilitation quality, evidence to that effect needs to be provided.
A Board member asked how the Patient-Driven Payment Model, which will go into effect in October 2019, would affect skilled nursing facilities in terms of staffing and providing rehabilitation services and whether safeguards are in place to prevent radical shifts or cuts in care delivery. Dr. Lipp said CMMI does not know or dictate what facilities are going to do but does monitor to ensure that changes intended to improve the system do not cause adverse outcomes for patients. Dr. Miller said patient complaints are monitored during program shifts, which is how Medicare judges the success or failure of the program.
A Board member asked how the FDA–CMS Parallel Review process helps investigators. Dr. Miller said the parallel review path should save time and money. Investigators can always come talk to CMS informally while concurrently in FDA discussions. Communication is key.
National Center for Complementary and Integrative Health (NCCIH): Impact on Rehabilitation
Helene Langevin, M.D., Director, NCCIH
NCCIH’s strategic priorities are: (1) mind and body practices; and (2) natural products, such as herbals or probiotics. Pain is an important focus at NCCIH. A 2012 survey indicated that musculoskeletal pain (e.g., back, neck, joint) is the main reason adults use mind and body practices, such as massage or acupuncture. This aligns with NCMRR’s priority of preventing and treating musculoskeletal dysfunction as secondary conditions of physical disabilities.
In recent years, the emphasis on treating musculoskeletal issues has shifted from “fix the broken part” by surgery or physical therapy to neuro-affective chronic pain components. After an injury has lasted more than 3 months, patients are often told that the tissues have healed, and the brain is responsible for any ongoing pain. But have the tissues really healed, and what tissues are involved? The term “musculoskeletal tissues” covers a number of different tissues, including connective tissue. Specialized connective tissues (e.g., tendons, ligaments) and non-specialized connective tissue, such as fasciae, range all over the body.
Connective tissue remodels itself in response to mechanical forces, which include gravity, externally applied forces, and muscle contraction. Connective tissue responds to both activity and inactivity. When the body does not move, such as when a broken limb is immobilized, the connective tissue remodels itself and scarring can occur, further restricting movement. As connective tissue becomes stiffer and shorter, muscles become unbalanced and predisposed to atrophy and loss of strength. Connective tissue drives the process of muscle shortening.
Rehabilitation aims to retrain muscles but restoring connective tissue to its optimal length is also important. When muscles and connective tissue are not in the appropriate relationship, this predisposes the patient to injury. In the presence of chronic pain, patients reduce their movement, which can cause stiffening of the muscles and alterations in the force distribution in the connective tissues, predisposing the patient to more severe injury and damage to joints. Preventing this pain-related progression of muscle and connective tissue abnormalities is critical.
Mind and body therapies can help prevent chronic musculoskeletal pain. Medications or cognitive behavioral therapy can help with descending pain inhibition and activate pathways to help to decrease pain. These techniques can also affect the central nervous system to increase gray matter volume and white matter integrity in the brain. Cognitive behavioral therapy can also improve fear of movement—an important component of musculoskeletal pain—by changing movement patterns, which activates muscles and affects the connective tissue.
Techniques such as yoga and hands-on direction of movements can help patients relax, re-educate their movement patterns, and realign the joints. However, if the connective tissue is too thick or too painful for the muscles to remodel, direct force to the tissues from massage or physical therapy can facilitate remodeling.
Animal studies with rats have shown that massage improves range of motion, lessens the amount of fibrous collagen in the connective tissue, and reduces fibrosis around the median nerve. Dr. Langevin referred to her own research with rats that found that simple stretching reduced pain sensitivity and macrophage infiltration in the tissues.
Although inflammation is an important component of the response to injury, continued inflammation once the acute injury is resolved can cause chronic pain. Stretching activates a body mechanism that releases molecules derived from dietary omega-3 fatty acids called specialized pro-resolving mediators, which promote the natural resolution of inflammation. This finding shows that the forces that are generated in musculoskeletal tissues affect immune responses, such as inflammation, occurring in those same tissues.
In summary, mind-based cognitive therapies and movement-based therapy can have an effect on changes in behavior, movement patterns, efferent output to muscle, and connective tissue remodeling. Manual-based therapies can also affect connective tissue remodeling and reduce inflammation. Unfortunately, research in this area tends to be siloed in the separate areas of physical therapy rehabilitation, immunology, orthopedics, and neuroscience. Because of its inherent focus on the whole body and its emphasis on partnerships, integrative health has a potential role to facilitate better interface among these research fields.
Dr. Langevin suggested two potential areas for partnering with NCMRR: (1) mind and body approaches to the treatment and prevention of chronic musculoskeletal pain in individuals with physical disabilities; and (2) mechanisms of reversible connective tissues and muscle contribution to reduced mobility and impaired function following injuries.
Dr. Nitkin said that the presentation made clear the link between the physical and psychological factors influencing pain and asked how to get the different specialties to start collaborating. Dr. Langevin said the job of integrative medicine is to point out these disconnects to the various fields. For example, NIDDK might be interested in exploring whether breathing influences digestion. Dr. Nitkin suggested exploring the relationship between nutrition and the microbiome.
Dr. Bianchi asked whether NCCIH intends to explore complementary medicine approaches used in other cultures. Dr. Langevin said NCCIH is very interested in such areas, citing traditional Chinese medicine and Native American healing systems. Cultures often combine the total mind and body approach by linking a nutritional element, like local plants, with a spiritual component.
An attendee representing the occupational therapy (OT) research community suggested including OT among the entities doing research and asked whether NCCIH receives grant applications from occupational and physical therapists. Dr. Langevin said that because there is significant overlap among professions, NCCIH tries to be agnostic about specific professional groups and instead focus on the treatment intervention. She agreed there are not enough applications from OT.
A Board member asked whether there are grant applications about intrinsic changes in musculature for populations with disabilities. Dr. Langevin said there are not, but this would be a perfect area to pursue, because these populations have pain problems and more attention should be paid to connective tissue and fibrosis of muscle (e.g., in patients with strokes). More work is needed on imaging techniques to improve diagnoses and treatment.
Rehabilitation Research Plan: Progress and Request for Input
Alison Cernich, Ph.D., Director, NCMRR
The 21st Century Cures Act requires that the NIH Research Plan on Rehabilitation be revised every 5 years and submitted to Congress. The Trans-NIH Medical Rehabilitation Research Coordinating Committee continues to meet monthly to make recommendations for research priorities. A lot of progress has been made on the revised 2016 plan, which is to be submitted to Congress in 2021. The new definition of medical rehabilitation research will be included in the 2021 revision. The six draft priorities to date are: (1) Rehabilitation Across the Lifespan; (2) Community and Family; (3) Technology Use and Development; (4) Research Design and Methodology; (5) Translational Science; and (6) Research Capacity and Infrastructure.
Trans-NIH rehabilitation projects have increased in number and funding from 2015 through 2017; data for 2018 are not yet available. Across the NIH, rehabilitation research funding has increased by $100 million since 2014. In tracking funding across the six priority areas, most have either grown or remained stable, except for Community and Family, which is still lagging, although it is possible that this topic is being covered by agencies other than NIH. NCMRR does not support much applied translational research or many large clinical trials but does well with applied clinical research and basic research on specific conditions and mechanisms.
Considerable work has been done to stimulate research in rehabilitation. This includes holding six conferences and workshops over the past 4 years; sponsoring the Medical Rehabilitation Research Resource Infrastructure Network, which will be renewed in FY 2020. Numerous funding opportunities across ICs also help drive the field forward.
An RFI seeking additional input about the draft plan has been put out. In 2020, these draft priorities will be finalized, a scientific conference and town hall will be held, and the plan framework with draft priorities will be submitted to NABMRR. The final plan will be submitted to Congress in 2021.
Dr. Cernich asked the Board for input on what the framework of the plan should be, how to reflect the progress being made to the field, whether there should be any changes in the priorities or the way they are tracked, and whether there are other areas that should be addressed.
Board members provided the following input on the plan:
- Think more about the implementation plan to translate what is being done more widely. The challenge is that there are a relatively small number of ready-to-go interventions in rehabilitation.
- Be consistent with the NICHD approach by identifying certain areas that cut across all the priorities. For example, perhaps Community and Family should be seen as interwoven across many other priority areas, such as Rehabilitation across the Lifespan or Technology Use and Development, rather than a standalone priority. However, another Board member countered that this could lead to important concepts becoming an afterthought rather than a focus. Removing Community and Family as a priority might dilute issues such as caregiving.
- Provide more information on specific end goals to provide clarity for those who evaluate funding. Currently, some priorities feel like a goal and others feel like a process. Because so much money is spent collaboratively, evaluate the other ICs in terms of where the most synergy for the dollar is.
- Think about the priorities as a continuum, from lab-based clinical trials to pragmatic trials to the implementation of practices that have been identified as useful. Dr. Cernich noted that the research plan is a living document; even if the priorities remain the same, specific areas of emphasis could change with time. The focus for some priorities could be narrowed to address specific needs or to address the study of specific conditions or complications. But, in general, the plan is diagnostically agnostic so that it can cover the interests of many different ICs and keep rehabilitation as the focus.
Dr. Cernich summarized the key themes she heard so far: Look at specific areas of science versus process of science; address how to get research into practice; and balance weaving in relevant concepts without losing a critical focus on those concepts. She asked for input about the current framework of the plan and how to balance weaving in some concepts across the plan without diluting their importance. This led to further comments from the Board:
- There is a rich body of processes and science that are known to make a difference. Whatever the categories are, the key is to get this out to those who will benefit.
- Weave in successful trends, such as large-data science and wearable devices. Use this document to help determine what works, future trends, and what is no longer needed.
- Consider a bigger footprint for resource infrastructure projects that result in cutting-edge ideas such as regenerative rehabilitation, which does not seem to fit in here. Dr. Cernich said regenerative rehabilitation is referenced in both Translational Science and the Rehabilitation across the Lifespan.
- Some occupational and physical therapy interventions are not covered. The plan should drive some of these effective interventions to become mainstream practices.
- Physical therapy is a young profession, and research capacity is lagging behind. What is in the pipeline to move this forward? Is there a way to refocus this priority? Dr. Cernich said that about $5 million of the $72 million NCMRR budget is spent on research infrastructure and capacity development, which is in line with the size of the portfolio. Ten percent of the budget goes to training, so 15 percent of the budget is devoted to building workforce capacity. In terms of portfolio balance, the number of projects is dipping, and this should be explored. The biggest growth in research design and methodology is with the growth (albeit slight) of clinical trials and the use of available data.
- Dr. Nitkin noted that the vast majority of what is ultimate funded is driven by peer-review scoring. If important rehabilitation areas, such as Community and Family, are not appropriately represented, is this due to the lack of applications or is it a matter of how these proposals are prioritized by peer review? Thus, why those grants are not scoring better and what must be done in terms of training, development, and incentivizing to make those grants happen. There is also a need to support people who are working in different silos but doing complementary work. Think about what kind of collaborations should be incentivized and how to make the plan match up with the opportunities and needs for the rehabilitation field.
- The plan is missing the mixed-method approach or qualitative analyses, which are needed to get to community/family caregiving issues. Interviews and focus groups in a mixed-method approach are used to get to different kinds of answers.
- Study section reviewers need to be trained so they understand the various types of trials, such as pragmatic versus explanatory trials, if research is to move forward. Dr. Cernich agreed that NCMRR needs to do a better job of understanding how rehabilitation trials are reviewed and educating applicants to help them succeed. A Board member noted that there are other methodologies besides randomized-control clinical trials (e.g., pragmatic trials and caregiver/family experiential data) to help clarify why things do or do not work in the field.
- A Board member asked about opportunities for elevating the knowledge base of reviewers. Dr. Cernich said that rehabilitation grants go to many different study sections, so it is not feasible to educate every study section. Nonetheless, NCMRR has provided the Center for Scientific Review (CSR) with more than 100 potential reviewer recommendations to help get appropriate rehabilitation expertise on panels and keeps the CSR apprised of rehabilitation priorities. Dr. Nitkin also noted that rehabilitation applications that goes to a peer review panel that does not usually see such applications can spark more interest because it is seen as a novel topic.
Dr. Cernich summarized the framework comments, saying it appears that that the overarching priorities still apply but a change in focus may be needed. She asked the Board whether all of the priorities should be retained. Board members provided the following input:
- The priority Technology Use and Development describes two completely different things. More clarity is needed about the timeline for implementation of the various elements of the priorities. Dr. Cernich noted that timelines could affect the NCMRR funding line, and that some focused funding could be done both singly and collaboratively. Thus, prescribed funding opportunities could be another way for NCMRR to refocus.
- Pragmatic research is buried in the Research Design and Methodology priority. Is it important enough to be better highlighted?
- Ten years from now, it will be clear how or whether the priorities have improved the lives of underrepresented minorities. The issue needs to be addressed now to ensure this improvement happens.
- Technology Use and Development, Research Design and Methodology, and Translational Science appear to be parts of a continuum. The plan could be strengthened by finding ways to link with scientists doing basic research in regenerative rehabilitation areas, such as stem cells, cell-based therapies, and genome-wide screening. Dr. Cernich said that some of this type of research is occurring in the All of Us program for persons with disabilities and provides an opportunity for rehabilitation to enter the precision medicine world. An attendee observed that the basic researchers need the rehabilitation world to inform them of how to make their studies more relevant.
- In the last 5 years, additional capacity has been developed by the Patient-Centered Outcomes Research Institute (PCORI) that fits into the concepts of precision health and patient engagement. That capacity could be interwoven into some of these priority areas.
- The term “translation” might be used for the technology readiness level to describe everything from basic science to getting into clinical practice and as a way to analyze where the emphasis is.
- Consider unpacking Rehabilitation Across the Lifespan with selected priorities, such as pediatric rehabilitation, prevention of secondary conditions, and disparities and rehabilitation. Look at the stage of Research Design and Methodology and of Translational Science to track content and the maturity of the science within the priorities. It is also important to trace progress of scientists seeking rehabilitation funding at various career stages as part of the research rehabilitation capacity piece of the data.
Dr. Cernich noted that global investment in rehabilitation is a gap area that is not included in the plan and asked whether it should be a priority. Board members responded as follows:
- Much of the work resulting from the broad priority areas could translate internationally.
- It is worth considering what could be learned from creative World Health Organization–driven initiatives in each of the priority categories and what could be implemented here.
- It is challenging to go global until there is certainty that there is something good to offer.
- Easily translatable innovations in telemedicine and tele-rehabilitation (e.g., an app for simple diagnostics or online physical therapy) should first be developed here.
- It would be valuable to evaluate the scope of what is already happening globally to determine whether there are areas for sharing knowledge or collaboration.
- There are significant opportunities to improve science by collaborating with other countries, some of which are technologically savvy but offer little rehabilitation. There are also opportunities to assemble unique control groups in other countries.
- An attendee suggested extending care models, such as by having physical therapists train new trainers, who can then bring care to areas with limited access to care.
Dr. Cernich asked what the Board would like to see in the plan in terms of federal coordination and collaboration. Board members responded as follows:
- PCORI, a quasi-federal agency, is a resource that funds important rehabilitation studies. How would the field be affected if PCORI goes away? Should the plan address this? Dr. Cernich suggested that Board members who share this concern make this clear in their written comments to the RFI.
- Continued interaction among the federal funders (e.g., NIH, DOD, Defense Advanced Research Projects Agency) is important.
- An attendee emphasized the need to be more proactive about coordination with CMS. Dr. Nitkin agreed, noting that better coordination with the FDA has already improved interactions and outcomes for the research community. Dr. Cernich added that CMS is not the only payer and more thought should be given to other payers because the rehabilitation population gets reimbursed under many different systems, such as Medicaid, private pay, and workers’ compensation.
- Partner with the Department of Education to assess needs of school children with disabilities.
Action Item: Consider future presentations by CSR representatives about study section issues and by the Department of Education about partnering opportunities for children with disabilities.
Overview of Data and Science Funding Opportunities
Valerie Florance, Ph.D., NLM
The National Library of Medicine (NLM) is only funding institutes at NIH whose grants focus solely on biomedical informatics and data science research and training. NLM participates in other special NIH initiatives where novel informatics could be developed. NIH has developed a strategic plan for data science.
There has been debate about whether NIH should provide long-term support to resources, such as databases, knowledge bases, and tool development, since this takes money away from research. But because data are so vital for research, NLM will be approved to issue funding announcements for resource (not research) grants to support repositories, a decision that ultimately will free up money for research because many of these resource costs are embedded in research grants. NIH is also working with cloud storage providers, including Google Cloud and Amazon.
Dr. Florance described the three pillars of the new NLM Strategic Plan 2017–2027:
- To accelerate discovery and advance health through data-driven research. The grants are intended to be accessible to the widest possible audience while still protecting privacy. Although the focus is informatics, every grant must also have an application to a health area, such as a grant on using data mining to improve colorectal cancer screening and risk assessment.
- To reach more people in more ways through enhanced dissemination and engagement. A new initiative under this pillar is to focus research on helping people manage their own health data or that of others. Such grants involve using audio-recorded medical visits to make the next visit easier, using cell phone apps, and developing resources to promote health literacy for incarcerated populations. Another resource is the National Network of Libraries of Medicine (NNLM), a powerful information-sharing network.
- To build a workforce for data-driven research. NLM spends about 20 percent of its grant budget on pre- and postdoctoral training in biomedical informatics and data science. Many of the trainees are cross-trained, because they need a health focus in addition to informatics. Trainees with these skills, who are funded for 5 years, might be very interested in NCMRR research projects. NLM brings its trainees together every year, an opportunity for ICs to meet and recruit them.
The NLM grants budget for FY 2019 is $64.268 million, with 53 percent of the money going to research project grants. About 20% goes to NNLM. All NLM research grants are investigator‑initiated. A list of the 191 research grants that NLM is funding in FY 2019 can be found on the NIH RePORTer. NLM’s webpage also links to its grant awards and abstracts. Researchers can also use the NIH RePORTer to find partners and learn what topics ICs are funding.
Dr. Cernich noted that NLM is funding one grant on reproductive health and disabilities and another on management of obesity and appropriate nutrition for people with disabilities.
A Board member asked what professional degrees NLM investigators have. Dr. Florance said degrees vary but with resource grants, investigators are strongly encouraged to include health science librarians and faculty from minority-serving institutions.
A Board member asked whether health science librarians are an untapped resource for big-data interdisciplinary teams. Dr. Florance said there are more than 120 health science libraries in the U.S. and Canada with staff trained in data management. These librarians are an excellent resource.
A Board member asked about the relationship between the current data-science initiatives and the Big Data to Knowledge (BD2K) program. Dr. Florance said NIH has redirected the BD2K program to be more cloud-oriented. The Common Fund is supporting this effort while NIH searches for a director for a new Office of Data Science Strategic Initiatives.
Dr. Cernich said that some rehabilitation research generates an enormous amount of data and asked how this relates to using cloud computing. Dr. Florance said the ultimate goal for the cloud is to allow data and tools to be stored and grow as investigators contribute their own data. Amazon and Google are willing to advance the cloud because they can develop tools and training around it that might be made available.
Dr. Cernich asked whether NLM is looking at new technologies for data encryption. Dr. Florance said her experience is with the extramural community, but NLM would support this kind of research as long as it is novel enough to move the field forward and has a health impact.
SCI 2020: Launching a Decade for Disruption in Spinal Cord Injury Research Update
Lyn Jakeman, Ph.D., Director, Division of Neuroscience, NINDS
Dr. Jakeman summarized the very successful 2-day SCI 2020 conference held in February 2019. The keynote talks set the stage for the urgent need to accelerate the pace of SCI research that would actually make a difference. NCMRR Board member Rob Wudlick spoke about the experience of living with a complete SCI.
The three objectives were to review the growth in state of the science; break down silos and barriers by bringing together people who do not normally work with each other, including clinicians, pre-clinical researchers, healthcare professionals and caregivers, engineers, industry, and people living with SCI; and identify SCI research priorities from varying perspectives. Dr. Jakeman reviewed the panel discussions and the research priorities they identified as follows:
- Fire and Smoke elucidated what is feasible and how to improve management of patients coming to the emergency room with SCIs. Research priorities include the following:
- Develop an optimized approach and infrastructure for treating acute SCI.
- Align preclinical studies with clinical conditions and what patients need.
- Beyond the Gap was about repair of SCIs that transect the spinal cord. The focus was on preclinical research. Research priorities include the following:
- Accelerate research and development of therapies for SCI repair and recovery by using state-of-the-art technology, combination therapeutics, and data sharing.
- With Us, Not For Us provided the perspectives of people with SCI and their advocates and caregivers. Given that the definition of “disrupt” is to prevent something from continuing as usual, the status quo is not okay and there is an urgent need to do more now. SCI research should be done not just for people with SCI, but with them - engaged at all points. Research portfolios should reflect the needs of the people living with SCI, requiring an awareness from the research community and grant reviewers of what those needs are.
- No Plateau! a panel chaired by NCMRR Board member Dr. Field-Fote, discussed activity-based improvement in recovery. Research priorities include the following:
- Improve evidence and implementation of functional recovery with use-dependent plasticity, neuromodulation, and big data. Study designs should be informed by outcomes, risks, and benefits important to people with SCI.
- SCI Health and Secondary Health Effects described SCI in the context of secondary health issues, such as bladder function and infections, which are often ignored. Research priorities include the following:
- Improve knowledge of the full range of health impacts of chronic SCI through multidisciplinary studies of behavioral, lifestyle (nutrition, bowel and bladder function), and environmental factors in a whole-body way.
- Technological Facilitation tackled the issue of devices that are used for rehabilitation or to aid independence and how those two goals integrate. Research priorities include the following:
- Expand the use, usability, and availability of assistive technology to promote function and improve recovery after SCI. Incorporate user input, comparative effectiveness research, and data-sharing strategies.
Next steps include the creation of a newsletter for SCI 2020, making meeting materials available on the Open Science Framework, preparing a state-of-the-science paper, and drafting an RFI for public comment on the priorities.
A Board member asked whether the focus was on both traumatic and embryonic SCI. Dr. Jakeman said the focus was on traumatic SCI because of time constraints.
Liaison to NICHD Advisory Council Update
Kenneth Ottenbacher, Ph.D., OT, University of Texas Medical Branch
Dr. Ottenbacher, the Board’s liaison to the National Advisory Child Health and Human Development (NACHHD) Council, reported on the January 2019 NACHHD meeting. Dr. Bianchi discussed recent NICHD workshops, meetings, and programs and reported on an impact analysis of 10 large NICHD programs and how these programs ultimately impact public health and practice guidelines. There was considerable discussion about the NICHD strategic planning process, and the NACHHD provided additional input. Presentations included an update on the NICHD training and career-development programs (which were found to be too heavily weighted toward K12 awards); a report on health and demographic disparities in recovery from Hurricane Katrina in the New Orleans Vietnamese population that included an interesting “Voice of the Participant” perspective from a Vietnamese woman who works with the researchers as a “culture broker” to facilitate community outreach; and a report on NICHD inclusion data for women and minority populations. More detailed information about the NACHHD can be found at https://www.nichd.nih.gov/about/advisory/council.
A Board member asked about the NICHD impact analysis. Dr. Cernich said this analysis looked at 10 of NICHD’s large programs, which are rather diverse but include several clinical networks. The discussion focused on whether to stay invested in large networks. The NICHD provided a number of different metrics to the NABMRR that indicated that the networks were successful, and this would be used for strategic planning in terms of where to make future investments.
NIH State of the Science Conference on Rehabilitation: Planning: Goals and Direction
Alison Cernich, Ph.D., Director, NCMRR
The rehabilitation conference held in 2016 was aimed at energizing the field about the breadth of opportunities in rehabilitation research across the NIH and getting feedback on the rehabilitation research plan. Dr. Cernich asked the Board for input about constructing the 2020 conference in terms of goals, focus of the scientific presentations, methods of garnering broad community participation, feedback on the research plan revision, and how to incorporate progress to date and future plans. Proposals from the trans-NIH community include focusing on trans-NIH or trans-federal initiatives, reporting on progress to date from the NIH Rehabilitation Plan and addressing gaps, and looking to the future by defining priorities based on the state of the science.
The Board provided the following input on potential goals for the conference:
- As with SCI 2020, organize around particular themes, such as pain or wheeled mobility, that cut across areas of disability that have common rehabilitation goals.
- Describe what was promised, what was done, and what will be done in the future.
- Address the urgency of what can be done now, not “someday.”
- Establish goals such as getting information to sharpen focus, disseminate information, or bring in more people to continue the work. Significant work done at NIH should be disseminated with an eye toward bringing in more collaborators.
- Attract new people to the field and disseminate information.
- Give rehabilitation research greater cachet by presenting how exciting it is.
- Present cutting-edge issues such as trans-humanism, the idea of augmenting ourselves to extend our lives. This raises serious ethical questions, such as CRISPR babies in China.
- Discuss whether the field is researching the right things to connect to the needs of patients. Highlight companies that succeed because they address consumers’ needs. Dr. Nitkin noted that SCI 2020 revealed the potential mismatch between what academics focus on and what consumers really want.
- Present the review of the past and progress that has been made in the keynote. This conference should transform people’s thinking, with a focus on the rehabilitation plan topics such as pain, aging, precision health, and the consumer.
- Look less to the past and more to where the gaps are and where to go in the future.
- Address the powerful message of urgency and how to translate basic research into implementation in the clinic across the whole spectrum, including industry and the FDA.
- Have a panel of successful innovators and some who have failed. (Dr. Cernich said she would consider the possibility of an “epic failure.”)
Dr. Cernich said the discussion so far indicated that progress should be mentioned but not treated as a major highlight. The focus should be on the future, with discussion of what new types of collaboration are needed and how to push toward implementation. The individuals who will receive the interventions should be an integral part of the program.
The Board provided the following suggestions for themes to be highlighted:
- Dr. Nitkin suggested precision medicine, to explore the issue of how to tailor interventions to individual needs and prognoses and optimize the outcomes. A Board member noted the transformational change with spinal muscular atrophy (SMA), with an FDA-approved gene therapy about to be released. Patients in this population who did not have the benefit of this therapy must be treated throughout the lifespan for mobility impairment. An exciting presentation might weave together the precision medicine and rehabilitation aspects.
- Discuss how to optimize performance and function in rehabilitation and move it forward.
- Discuss adaptive fitness or physical therapy for incremental outcomes.
- Focus on how to help people understand what implementation involves. Dr. Cernich asked whether this meant demonstrating what can be done in an implementation trial in terms of outcomes or giving people an overview of the science. The Board member said there is a lack of understanding about the methods and barriers in implementation science, so examples of implementation science in relation to rehabilitation should be shown.
- Describe the translation trajectory, from preclinical small to large animals, then to human lab‑based studies, to the clinic, and on to further refinements. A Board member said looking at obstacles along the implementation pathway is a good framework for all the work that is being done. Another Board member suggested discussing multi-component intervention barriers to pragmatic trials and some of the challenges associated with those trials. Another Board member said it that describing how the barriers and obstacles are being overcome to get to what works is equally important.
- Use the SMA story as an exciting example of a model.
- Instead of “bench to bedside,” say “bench to back into the community.”
- Discuss the coming effect of digital health and artificial intelligence.
- Understand the audience and include what they should know to move the field forward. The audience should include change agents willing to reimagine rehabilitation medicine.
Dr. Cernich said she heard the themes as emulating the SCI 2020 “disruption” focus and highlighting precision medicine, technology, industry partnership, and implementation perspectives. She asked how to enable this, since there might not be ready examples for all of these themes. She also wondered about bringing in other fields, which would highlight collaborations but not necessarily be a one-to-one fit with rehabilitation. There could also be outreach beyond NIH. Board members provided the following input on this question:
- An attendee recounted the history of NINDS with the SMA initiative and gene therapy development, saying NIH was a great mover in that discovery by making collaborations within NIH advance the research quickly.
- A Board member mentioned an initiative on healthy aging in a digital world and suggested applying this to a population with disabilities across the lifespan.
- Look outside of rehabilitation to find what did and did not work and to better understand failures and good dissemination strategies.
- An attendee mentioned a Veterans Affairs program focusing on implementation science to take research findings and translate them to the healthcare side.
Dr. Cernich asked how to engage young investigators in rehabilitation and where to find them. Board members made the following comments:
- Organize a session and invite K12-supported career development scholars. Dr. Cernich said she is thinking of people even younger and wondered how to get younger children to think about rehabilitation as a field of science they want to join. She noted that children ages 9 to 15 at the NIH Take Your Child to Work Day were very engaged with the robotic exhibition and began to think differently about rehabilitation technologies. Such an approach could grow the field in a different way. A Board member noted that high school students have built many 3-D prosthetic hands. A Board member wondered whether these students see making a prosthetic hand as a rehabilitation project or an engineering project and suggested the need to channel this interest into rehabilitation. A Board member suggested that NCMRR challenge students each year to build a prosthetic or mimic the Microsoft Hackathon for children to develop rehabilitation products.
- Dr. Cernich then asked for volunteers for two subcommittees: The Scientific Conference Subcommittee and the Research Plan Revision Subcommittee. Several Board members volunteered to serve on these subcommittees.
Scientific Presentation: Mobile Devices to Extend the Reach of Rehabilitation
David Reinkensmeyer, Ph.D., Biomedical Engineering Department, University of California, Irvine
Dr. Reinkensmeyer said there is broad motivation to use wearables at home for monitoring, early detection, and assessment of treatment efficacy. There is abundant wearable technology (e.g., smart watches, sociometric badges, tattoo sensors, sensors in clothing), but it is still unclear how to use the vast data this technology provides. For example, pedometer technology is not optimized for people with disabilities, so their step counts are inaccurate.
Dr. Reinkensmeyer said that after stroke, the brain ‘searches’ for alternate pathways. His research indicated that somatosensory stability predicts stroke treatment outcome. After stroke, 50 percent of subjects have proprioception loss. Robotic therapy helped some subjects but not others. Researchers found that better proprioception at baseline predicted who would improve, which could inform clinical management. The amount of damage to the corticospinal tract also matters. With proportional recovery, measuring baseline arm impairment after stroke is 70 percent predictive of how well patients will do. Motivation is also important; patients said they liked robotic therapy because it helped them do what they could not do themselves. But there are very few studies of wearables as tools for exercise and rehabilitation (as opposed to just making measurements) for people with stroke or Parkinson’s disease.
Dr. Reinkensmeyer described his work to develop and commercialize consumer technology to help incentivize therapeutic movements in stroke patients.
- Although the brain has an algorithm for slacking off if movement is helped too much, a robot-assisted arm can still be effective because robots can play a psychological role in facilitating therapy.
- Subjects getting help from a finger robot were more motivated to continue therapy.
- The $60,000 Hocoma robot—which is used worldwide and has reported efficacy for SCI, Cerebral Palsy, and Multiple Sclerosis injury—is in many facilities, but more data are needed as to who is using it and how they are benefiting from it.
- The isometric MusicGlove utilizes a very popular isometric video game that requires specific finger movements to play. The MusicGlove was tested in both chronic and subacute phases. Participants self-adjusted the software to make training more challenging. A study of at-home subacute-phase stroke patients with various degrees of hand impairment demonstrated that the MusicGlove was feasible and effective and that functional gains were larger when the training was initiated in the subacute rather than chronic phase.
- The FitMi “hockey puck” was developed to motivate exercise in stroke patients whose hand impairment was too severe for the MusicGlove. It centered around a video game with music that encourages the user to continuously turn the puck over.
- The FitMi PLUS device features cups, switches, and doorknobs wired with sensors, in a game to help with functional activities.
- The Manumeter, a finger ring worn with a wristwatch sensor, is similar to a Fitbit for fingers. A study of 22 chronic stroke patients showed no change in primary outcome between Manumeter users and controls, but users subjectively liked the device.
- The MiGo, a wristwatch-like device to measure wrist acceleration, has a social rehabilitation option that allows the wearer to join a group for chats.
- The LARA wheelchair allows wheelchair users to leverage their weak arms to “ambulate” in the wheelchair. A study of LARA users versus controls found that the device was too complex for people to learn to ambulate very well.
Dr. Reinkensmeyer’s company is FlintRehab (https://www.flintrehab.com ). There are more than 6,000 MusicGlove and FitMi users and 400 MiGo users. Widespread use of consumer stroke technology may provide new ways to influence home practice and determine to what extent recovery depends on community-based upper extremity use.
A Board member noted that patients often prefer low-tech devices. Dr. Reinkensmeyer agreed, saying more sophisticated technology is good for doing science, but simple is best for patients.
An attendee asked whether using the term “consumer technology” was intended to avoid FDA requirements. Dr. Reinkensmeyer said his model is to make production of consumer devices economically feasible and widely available. He added that funding has come from NIH Small Business Innovation Research grants to develop or improve technologies.
A Board member noted the interdisciplinary nature of Dr. Reinkensmeyer’s research. Dr. Reinkensmeyer said he fosters that interdisciplinary conversation by listening to users of the devices and having collaborators.
A Board member asked how therapists respond to the technology. Dr. Reinkensmeyer said therapists like low-cost tools that make therapy more interesting and doable at home. People can buy the devices without having a therapist, and the video instructions are clear.
A Board member asked whether the devices are being used for therapy as well as for measurements. Dr. Reinkensmeyer said the Manumeter and MiGo combine both.
A Board member asked if there is any technology to give care providers feedback when they help with exercises or try to prevent contractures. Dr. Reinkensmeyer said the wearable devices provide information about what dose of a particular exercise has been shown to be helpful. A Board member commended Dr. Reinkensmeyer’s attention to increasing the total dose of exercise by giving patients the ability to continue it on their own.
A Board member asked whether data from the device sensors has been validated. Dr. Reinkensmeyer said that using the data to get outcomes is essential but difficult.
Theresa Cruz, Ph.D., NCMRR
This concept is for a Program Announcement with Review (PAR), a renewal of the PAR-18-211, an early career (less than 7 years post-final degree) research program. It is an R03 mechanism at $100,000 per year for 2 years to collect preliminary data for a subsequent R01 application.
A Board member asked what portion of training is included in the “less than 7 years” period. Dr. Cruz said postdoctoral time counts toward the time. Exceptions can be made for residency and clinical training to add to the 7-year window, so the time period is flexible.
A Board member asked how many applications have been received in the first rounds. Dr. Cruz said 78 applications were received; about 20 percent were funded. Dr. Cruz clarified that NCMRR offers the smaller NICHD version of R03s.
A Board member asked whether there are additional restrictions. Dr. Cruz said applicants should not have had any similar National Science Foundation funding or independent funding other than a fellowship.
Board members observed that $100,000 is a very realistic budget to encourage R01s.
A Board member asked about the domains that the recipients chose. Dr. Cruz said the domains are very broad and include regenerative rehabilitation, stroke motor recovery, exercise, and validation of mobile health tools. The R01s may ultimately end in other institutes.
Vote: The Board unanimously approved the concept.
Comments from Retiring Members
Dr. Cernich thanked the retiring Board members and presented each with a certificate of appreciation. The retiring members each made remarks.
Dr. Friel said it has been an honor to serve and that she looks forward to seeing what happens next. She urged members to continue to ensure that the right research gets done.
Dr. Heinemann said it has been a privilege to serve and thanked Dr. Cernich and Dr. Nitkin for their leadership. He appreciated learning a lot about this small center with a big mission.
Dr. Hicks, a former NABMRR chair, thanked Dr. Cernich and Dr. Nitkin, saying it had been exciting to serve. He thanked his fellow members and lauded the experience’s collaborative nature.
Dr. Lanig, the current NABMRR chair, noted NCMRR’s responsiveness to the Board’s input and said the scientific conference discussion showed the strides that are being made.
Dr. Kaufman said he got his first NCMRR grant in 1992 and met Dr. Nitkin in 1996, so NCMRR has always been his research home. He said the strength of the Board was its diversity and collaboration.
Dr. Cernich thanked the Board members for their efforts and time. Dr. Lanig passed the gavel to the new chair, Dr. Edelle C. Field-Fote. The meeting was adjourned at 11:40 a.m.