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.

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

October 15, 2018
Integrating Stroke Survivors Into Cardiac Rehabilitation
Condition:   Stroke
Intervention:   Behavioral: Cardiac Rehabilitation
Sponsors:   University of South Carolina;   Novant Health Heart and Vascular Institute;   American Physical Therapy Association
Recruiting
October 11, 2018
Stimulation to Enhance Walking Post-SCI
Conditions:   SCI - Spinal Cord Injury;   Incomplete Spinal Cord Injury
Interventions:   Device: Soterix Medical tsDCS stimulator;   Other: Locomotor training
Sponsors:   University of Florida;   National Institutes of Health (NIH);   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not yet recruiting
October 10, 2018
Effect of Lifestyle Changes on BDNF Level After Stroke
Condition:   Stroke
Intervention:   Behavioral: Wellness in Rehabilitation program
Sponsors:   VA Palo Alto Health Care System;   Stanford University;   Spaulding Rehabilitation Hospital
Recruiting
October 4, 2018
A Precision Rehabilitation Approach to Counteract Age-Related Cognitive Declines
Conditions:   Cognition Disorders;   Brain Pathology;   Physical Disability;   Physical Activity;   Aging
Interventions:   Behavioral: Aerobic Activity;   Behavioral: Resistance Training;   Behavioral: Yoga;   Behavioral: Health Education
Sponsor:   University of Pittsburgh
Recruiting
October 9, 2018
Clinical Outcome Following Arthroscopic Knee Surgery
Condition:   Anterior Cruciate Ligament Injury
Intervention:  
Sponsors:   The University of Texas Health Science Center, Houston;   Memorial Hermann Hospital
Recruiting
October 9, 2018
Impact of Neuromodulation on Language Impairments in Stroke Patients
Conditions:   Stroke;   Aphasia
Intervention:   Device: tDCS
Sponsor:   Casa Colina Hospital and Centers for Healthcare
Recruiting
October 4, 2018
Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Condition:   Posttraumatic Stress Disorder
Interventions:   Behavioral: Compensatory Cognitive Training (CCT);   Behavioral: Treatment as Usual (TAU)
Sponsor:   VA Office of Research and Development
Not yet recruiting
October 9, 2018
Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Condition:   Tinnitus
Intervention:   Device: TMS for tinnitus
Sponsor:   Aaron Boes
Not yet recruiting
October 10, 2018
Ataxia, Imaging, and Exercise Disease Using MRI and Gait Analysis
Conditions:   Ataxia;   Spino Cerebellar Degeneration;   Spinocerebellar Ataxias
Interventions:   Behavioral: Aerobic Training;   Behavioral: Balance Training
Sponsor:   Columbia University
Not yet recruiting
October 10, 2018
4-aminopyridine Treatment for Nerve Injury
Condition:   Prostate Cancer
Interventions:   Drug: 4-Aminopyridine;   Other: Placebo
Sponsors:   University of Rochester;   Milton S. Hershey Medical Center
Not yet recruiting
View all on ClinicalTrials.gov

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