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

February 22, 2018
Towards Comparative Effectiveness in Military Vestibular Rehabilitation
Conditions:   Vestibular Problem;   Traumatic Brain Injury
Interventions:   Other: Generalized Vestibular Rehabilitation Treatment;   Other: Individualized Vestibular Rehabilitation Treatment
Sponsor:   Jorge Arango
Recruiting
February 22, 2018
Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery
Conditions:   Disc Degeneration;   Low Back Pain
Intervention:   Other: Exercise
Sponsors:   University of California, San Diego;   University of Zurich, Balgrist Hospital;   Spine Institute of San Diego (Spine Zone)
Not yet recruiting
February 20, 2018
Women in Cardiac Rehabilitation: Optimizing the Training Response
Conditions:   Exercise Training;   Coronary Artery Disease;   Women;   Cardiac Rehabilitation
Intervention:   Behavioral: Exercise training
Sponsor:   University of Vermont
Recruiting
February 12, 2018
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Condition:   Post-fire Rehabilitation of Firefighters in Sauna
Intervention:   Other: Sauna Rehabilitation
Sponsor:   University of Arizona
Not yet recruiting
February 19, 2018
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Condition:   TBI (Traumatic Brain Injury)
Intervention:   Other: Robotic gait training
Sponsor:   Indiana University
Recruiting
February 13, 2018
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
Conditions:   Stroke;   Hemiparesis
Intervention:   Device: Wearable sensors and biofeedback
Sponsors:   BioSensics;   Spaulding Rehabilitation Hospital
Not yet recruiting
February 9, 2018
Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability
Condition:   Ankle Sprains
Interventions:   Other: High Velocity Low Amplitude mobilization;   Other: Exercise protocol
Sponsors:   Shenandoah University;   Methodist University, North Carolina
Not yet recruiting
February 12, 2018
Medical and Resource Facilitation Intervention After Traumatic Brain Injury
Conditions:   Brain Injuries, Traumatic;   Family;   Physician's Role
Interventions:   Behavioral: Medical Care and Resource Facilitation;   Other: Usual Care
Sponsors:   Mayo Clinic;   Minnesota Brain Injury Alliance;   Minnesota Department of Health
Not yet recruiting
February 22, 2018
Baltimore HEARS: Hearing Equality Through Accessible Research & Solutions
Conditions:   Age-related Hearing Impairment 1;   Personal Communication
Interventions:   Behavioral: Baltimore HEARS;   Device: Baltimore HEARS
Sponsors:   Johns Hopkins University;   National Institute on Deafness and Other Communication Disorders (NIDCD)
Not yet recruiting
February 20, 2018
Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
Conditions:   Spinal Cord Injuries;   Trauma, Nervous System
Interventions:   Device: MyndMove®;   Other: Conventional Therapy
Sponsors:   MyndTec Inc.;   U.S. Army Medical Research Acquisition Activity;   United States Department of Defense;   PATH
Not yet recruiting
View all on ClinicalTrials.gov

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