Clinical Trials in Medical Rehabilitation

Recently published federal rules and requirements for clinical trials

  • NIH DIrector's Statement: Update on NIH’s efforts to address sexual harassment in science
    In this statement released February 28, 2019, the NIH senior leadership announced the actions they were taking as they await the Working Group of the Advisory Council to the Director (ACD) on Changing the Culture to End Sexual Harassment recommendations and other input to strengthen thier efforts. These thems include: demonstrating accountability and transparency; clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency; providing clear channels of communication to NIH; and listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions.
  • Statement on Article Publication Resulting from NIH Funded Research
    To help protect the credibility of papers arising from its research investment, NIH encourages its stakeholders, including grantees, contractors, intramural researchers, and librarians, to help authors: 1) adhere to the principles of research integrity and publication ethics; 2) identify journals that follow best practices promoted by professional scholarly publishing organizations; and 3) avoid publishing in journals that do not have a clearly stated and rigorous peer review process.
  • Clinical Trial Requirements for Grants and Contracts
    NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.
  • Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs (NOT-OD-18-001) (Published November 6, 2017)
    The purpose of this notice is to provide prospective applicants for career development, NRSA fellowships or training grants, and research education grants advanced information about the upcoming funding opportunity announcements (FOA), expected dates of FOA issuance, and application due dates. As indicated in NOT-OD-17-043, effective January 25, 2018, all grant applications with plans to conduct independent clinical trials must be submitted in response to an FOA which specifically states that independent clinical trials are allowed.
  • Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101) (Published August 31, 2017)
    This policy amends the definitions of, and policies supporting, early stage investigators (ESIs). In addition, it creates a new policy for early established investigators (EEIs), previously referred to as mid-career investigators, and describes how NIH will monitor the implementation of the policy to determine the impact on ESI and EEI diversity in the NIH portfolio.
  • Federal Policy for the Protection of Human Subjects (Published January 19, 2017)
    The Department of Health and Human Services has updated the Common Rule for Protection of Human Subjects. This will impact specific policies and programs in NIH and implementation as of January 21, 2019, including review of the grant application by the IRB, posting of consent document, and categories of exempt research.
  • Inclusion Across the Lifespan - Policy Implementation (Published December 19, 2017)
    The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also clarifies potential justifications for age-based exclusion criteria, and requires participant age at enrollment to be provided in progress reports The policy applies to all grant applications submitted on or after January 25, 2019. Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy.

NIH Medical Research Initiatives

Journal Articles

Bamman MM, Cutter GR, Brienza DM, Chae J, Corcos DM, et al. Medical Rehabilitation: Guidelines to Advance the Field with High-Impact Clinical Trials Arch Phys Med Rehabil. 2018 Aug 24. pii: S0003-9993(18)31113-4. doi: 10.1016/j.apmr.2018.08.173. [Epub ahead of print] PMID: 30148997.

Ronald L. Wasserstein, Allen L. Schirm & Nicole A. Lazar (2019) Moving to a World Beyond “p < 0.05” The American Statistician, 73:sup1, 1-19, DOI:10.1080/00031305.2019.1583913/

NIA Clinical Research Study Investigator's Toolbox

This tool box provides researchers and their study teams with a central source of materials to plan studies, incorporate consistent processes, collect accurate data, and maintain appropriate safety oversight.

NIH Reporter

Learn about active NIH funded medical rehabilitation research projects.

Access the list on the NIH RePORT website.

Recently published on ClinicalTrials.gov

June 14, 2019
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
Condition:   Stroke
Intervention:   Behavioral: Home Telerehabilitation using HoVRS
Sponsors:   Rutgers, The State University of New Jersey;   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);   New Jersey Institute of Technology
Not yet recruiting
June 10, 2019
Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
Conditions:   Stroke;   Weakness of Extremities as Sequela of Stroke
Interventions:   Device: Indego Exoskeleton;   Other: Standard Rehabilitation
Sponsors:   University of Oklahoma;   Oklahoma City VA Health Care System
Not yet recruiting
June 11, 2019
Informatics Framework for Pulmonary Rehabilitation
Condition:   COPD
Interventions:   Behavioral: Best available care (BAC);   Behavioral: Telerehabilitation (TH)
Sponsors:   Icahn School of Medicine at Mount Sinai;   National Heart, Lung, and Blood Institute (NHLBI)
Not yet recruiting
June 10, 2019
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Condition:   Progressive Multiple Sclerosis
Interventions:   Device: G-EO System (Reha Technology AG: Olten, Switzerland);   Other: Conventional Physical Therapy
Sponsors:   Indiana University;   University of Alabama at Birmingham;   University of Ottawa
Recruiting
June 21, 2019
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Conditions:   Transtibial Amputation;   Peripheral Artery Disease;   Diabetes Mellitus
Interventions:   Behavioral: Error-augmentation gait training;   Behavioral: Error-correction gait training;   Behavioral: Supervised walking
Sponsor:   VA Office of Research and Development
Not yet recruiting
June 18, 2019
Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes
Conditions:   Amputation;   Diabetes Mellitus;   Neuropathy, Diabetic
Intervention:   Behavioral: Instructions to perform a motor task (external vs. internal focus instructions)
Sponsors:   University of Nevada, Las Vegas;   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not yet recruiting
June 11, 2019
Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients
Conditions:   Cachexia;   Malignant Solid Neoplasm
Interventions:   Procedure: Physical Therapy;   Other: Questionnaire Administration;   Procedure: Ultrasound
Sponsors:   M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Recruiting
June 14, 2019
Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
Conditions:   Stroke, Ischemic;   Stroke Hemorrhagic;   Stroke;   Hemiparesis;   Cerebral Vascular Accident
Intervention:   Device: Keeogo™ Dermoskeleton
Sponsor:   B-Temia, Inc.
Not yet recruiting
June 13, 2019
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
Condition:   Spinal Cord Injuries
Interventions:   Behavioral: Behavorial; memory exercise;   Behavioral: Placebo; memory exercise;   Behavioral: Behavioral: speed exercises;   Behavioral: Placebo speed training
Sponsors:   Kessler Foundation;   National Institute on Disability, Independent Living, and Rehabilitation Research
Recruiting
June 14, 2019
Development of a FES Device for Hand Use During Arm Activities Following Stroke
Conditions:   Stroke;   Hand Function
Intervention:   Device: ReIn-Hand device assisted home-based practice
Sponsor:   Northwestern University
Not yet recruiting
View all on ClinicalTrials.gov

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