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

December 10, 2018
Laryngeal Adaptation for Speech and Swallowing
Conditions:   Stroke;   Spinocerebellar Ataxia;   Cerebral Stroke;   Dysphagia;   Dysarthria
Interventions:   Device: Intermittent Perturbation to Continuous Perturbation;   Device: Continuous Perturbation to Intermittent Perturbation
Sponsors:   University of Florida;   National Institute on Deafness and Other Communication Disorders (NIDCD);   National Institutes of Health (NIH)
Recruiting
December 12, 2018
Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
Condition:   Spinal Cord Injuries
Interventions:   Other: Acute Intermittent Hypoxia;   Other: Sham Acute Intermittent Hypoxia
Sponsor:   Shirley Ryan AbilityLab
Recruiting
December 13, 2018
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Condition:   Soft Tissue Injuries
Interventions:   Device: RF and PEMF;   Device: Ultrasound
Sponsor:   Venus Concept
Recruiting
December 12, 2018
Improving Electronic Written Communication in Aphasia
Condition:   Aphasia
Interventions:   Behavioral: Texting Intervention (T-WRITE);   Behavioral: HandWriting Intervention (ORLA+WTG)
Sponsors:   Shirley Ryan AbilityLab;   James Madison University
Recruiting
December 4, 2018
Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
Condition:   Primary Knee Replacement Surgery
Intervention:   Device: Robotic exoskeleton device
Sponsor:   Stanford University
Recruiting
December 12, 2018
Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
Condition:   Aphasia
Interventions:   Device: Offline tDCS-before therapy;   Device: Sham tDCS;   Device: Offline tDCS-after therapy;   Device: Online tDCS
Sponsors:   Shirley Ryan AbilityLab;   National Institute on Disability, Independent Living, and Rehabilitation Research
Recruiting
December 7, 2018
Upright Back Posture Device Study
Conditions:   Back Pain;   Postural Low Back Pain;   Lower Back Pain
Interventions:   Device: Upright Go Device;   Other: Ergonomic Handout
Sponsors:   Columbia University;   Upright Technologies Ltd.
Recruiting
December 7, 2018
MyHand: An Active Hand Orthosis for Stroke Patients
Condition:   Stroke
Interventions:   Device: EMG Band;   Device: Shoulder harness
Sponsors:   Columbia University;   Wallace H. Coulter Foundation;   U.S. National Science Foundation
Recruiting
December 3, 2018
Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment
Condition:   Traumatic Brain Injury
Intervention:   Other: Neurotriage
Sponsor:   University of Texas Southwestern Medical Center
Recruiting
December 4, 2018
A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Condition:   Moral Injury
Interventions:   Behavioral: Impact of Killing (IOK);   Behavioral: Present Centered Therapy
Sponsor:   VA Office of Research and Development
Not yet recruiting
View all on ClinicalTrials.gov

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