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 U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
  • 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.

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

August 9, 2018
Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)
Condition:   Spinal Cord Injuries
Interventions:   Other: Physical exam and medical history;   Diagnostic Test: Assessments;   Device: Patient Instruction and use of Device (RePlay)
Sponsor:   The University of Texas at Dallas
Recruiting
August 8, 2018
Exercise Rehabilitation in Veteran Cancer Survivors
Condition:   Cancer
Interventions:   Behavioral: Exercise Rehabilitation;   Other: Control
Sponsors:   VA Office of Research and Development;   Baltimore VA Medical Center
Not yet recruiting
August 10, 2018
Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation
Conditions:   Aging;   Cardiovascular Disease
Intervention:   Drug: NG-Monomethyl-L-Arginine
Sponsor:   VA Office of Research and Development
Recruiting
August 2, 2018
Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface
Conditions:   Chronic Stroke;   Hemiparesis
Interventions:   Device: BCI Rehabilitation;   Other: Range of Motion Therapy
Sponsors:   Washington University School of Medicine;   Neurolutions, Inc.
Recruiting
July 31, 2018
Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease
Condition:   Parkinson's Disease
Intervention:   Other: Gait training
Sponsor:   VA Office of Research and Development
Recruiting
August 7, 2018
Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury
Conditions:   Anterior Cruciate Ligament Injury;   Anterior Cruciate Ligament Rupture
Intervention:   Other: Exercise Group
Sponsor:   Johanna M. Hoch
Not yet recruiting
July 30, 2018
Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Grade II-IV Brain Tumors
Condition:   Brain Neoplasm
Interventions:   Other: Questionnaire Administration;   Procedure: Transcranial Magnetic Stimulation
Sponsors:   M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Not yet recruiting
August 1, 2018
Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair
Conditions:   Hand Transplantation;   Peripheral Nerve Injuries;   Neurologic Rehabilitation
Interventions:   Device: Transcranial Direct Current Stimulation;   Device: Sham Transcranial Direct Current Stimulation;   Behavioral: Modified Constraint Induced Movement Therapy
Sponsors:   University of Missouri-Columbia;   Washington University School of Medicine;   Christine M. Kleinert Institute for Hand and Microsurgery
Not yet recruiting
August 3, 2018
Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery
Condition:   ACL Injury
Interventions:   Dietary Supplement: Protein (PROT);   Other: Control (CONT)
Sponsor:   Wake Forest University Health Sciences
Not yet recruiting
August 10, 2018
Outcomes After Spinal Cord Injury (OASIS)
Conditions:   Posttraumatic Stress Disorder;   Spinal Cord Injuries
Intervention:   Behavioral: Prolonged Exposure Therapy
Sponsor:   Baylor Research Institute
Recruiting
View all on ClinicalTrials.gov

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