Clinical Trials in Medical Rehabilitation

Recently published federal rules and requirements for clinical trials

  • 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.

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.

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

February 7, 2019
Enhancing Cardiac Rehabilitation Through Behavioral Nudges
Conditions:   Acute Myocardial Infarction;   Percutaneous Coronary Intervention;   Coronary Artery Disease;   Valvular Disease;   Chronic Stable Angina;   Chronic Stable Heart Failure
Interventions:   Other: Hospital-based CR + Movn Application;   Other: Choice of Hospital or home-based CR + Movn Application;   Other: Hospital-based CR + Movn Application + Nudge;   Other: Choice of Hospital or home-based CR + Movn Application + Nudge
Sponsor:   Denver Health and Hospital Authority
Not yet recruiting
February 11, 2019
Cognitive Rehab for Parkinson's
Conditions:   Parkinson's Disease;   Mild Cognitive Impairment
Interventions:   Behavioral: cognitive training;   Behavioral: active control cognitive training;   Behavioral: memory strategy training
Sponsor:   VA Office of Research and Development
Not yet recruiting
February 4, 2019
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
Condition:   Amputation
Intervention:   Other: Prosthetic/Bicycle Configuration
Sponsor:   VA Office of Research and Development
Not yet recruiting
February 11, 2019
rTMS to Improve Cognition in Parkinson's
Conditions:   Parkinson's Disease;   Mild Cognitive Impairment
Intervention:   Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
Sponsor:   VA Office of Research and Development
Not yet recruiting
February 7, 2019
FLO2 for Recovery After SCI
Condition:   Spinal Cord Injury (SCI)
Interventions:   Other: Daily AIH Block;   Other: Sham dAIH Block;   Other: Respiratory Strength Training Block;   Other: AIH + Strength Training Block
Sponsors:   University of Florida;   United States Department of Defense;   Brooks Rehabilitation
Not yet recruiting
February 1, 2019
Post-Stroke Optimization of Walking Using Explosive Resistance
Conditions:   Stroke;   Depression
Interventions:   Behavioral: Power training;   Behavioral: Stretching
Sponsors:   Medical University of South Carolina;   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting
February 4, 2019
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.
Condition:   Delirium, Cytochrome P-450 Enzyme System
Intervention:   Diagnostic Test: Cytochrome P450 test
Sponsor:   Advocate Health Care
Recruiting
February 1, 2019
Depression in Hemorrhagic Stroke
Conditions:   Stroke Hemorrhagic;   Depression
Interventions:   Drug: Fluoxetine;   Drug: Placebo
Sponsor:   University of Washington
Not yet recruiting
View all on ClinicalTrials.gov

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