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

April 20, 2018
Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
Condition:   Spinal Cord Injuries
Intervention:   Device: Hybrid Assistive Limb (HAL)
Sponsors:   Brooks Rehabilitation;   University of Florida
Not yet recruiting
April 13, 2018
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Conditions:   Breast Cancer;   Prehabilitation;   Physical Activity;   Surgery
Interventions:   Behavioral: Exercise;   Behavioral: Prehabilitation Education
Sponsors:   Milton S. Hershey Medical Center;   Penn State Rehabilitation Hospital
Recruiting
April 10, 2018
Cortical Priming to Optimize Gait Rehabilitation Post Stroke
Condition:   Stroke
Interventions:   Other: tDCS;   Other: AMT;   Behavioral: Treadmill training
Sponsors:   University of Illinois at Chicago;   National Institutes of Health (NIH)
Recruiting
April 17, 2018
Safety Evaluation of the ReWalk Restore Device in Subjects With Mobility Impairments Due to Stroke
Conditions:   Stroke;   Stroke, Acute;   Stroke Hemorrhagic;   Hemiparesis;   Hemiplegia
Intervention:   Device: ReWalk Restore device
Sponsor:   ReWalk Robotics, Inc.
Recruiting
April 9, 2018
Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction
Condition:   Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction
Interventions:   Other: Diet Intervention_AP-CPT;   Other: Diet Intervention_PP-PPT
Sponsors:   University of Connecticut;   Orthopedic Associates of Hartford;   United States Army Research Institute of Environmental Medicine;   University of California, Berkeley
Recruiting
April 17, 2018
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Condition:   Multiple Sclerosis
Interventions:   Device: Active RS-tDCS +At-Home Manual Dexterity Training;   Device: Sham RS-tDCS +At-Home Manual Dexterity Training;   Other: Manual dexterity training
Sponsor:   New York University School of Medicine
Not yet recruiting
April 6, 2018
Brain Markers of Improvements in Cognitive Functioning
Conditions:   TBI (Traumatic Brain Injury);   Brain Injuries;   Stress;   Attention Deficit;   Executive Dysfunction
Interventions:   Behavioral: State regulation skill training;   Other: Treatment-as-usual
Sponsors:   VA Office of Research and Development;   VA Northern California Health Care System
Recruiting
April 13, 2018
Retrospective Review of Amino Acid Formula Use at a Children's Center
Condition:   Children Requiring Amino Acid-based Formula Tube Feeding
Intervention:   Other: Enteral Formula
Sponsor:   Nestlé
Not yet recruiting
April 12, 2018
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Conditions:   Spinal Cord Injuries;   Metabolic Syndrome;   Dietary Modification;   Paraplegia;   Tetraplegia
Interventions:   Device: Functional Electrical Stimulation Leg Cycle Ergometry;   Behavioral: Diet
Sponsors:   Milton S. Hershey Medical Center;   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not yet recruiting
April 20, 2018
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
Condition:   Autism Spectrum Disorder
Interventions:   Drug: Balovaptan;   Drug: Placebo
Sponsor:   Hoffmann-La Roche
Not yet recruiting
View all on ClinicalTrials.gov

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