Search / Trial NCT06222502

Walking After Traumatic Brain Injury in Older Adults

Launched by NORTHEASTERN UNIVERSITY · Jan 16, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Brain Injury Tbi Walking Exercise

ClinConnect Summary

This clinical trial is studying how different activities can help improve walking in older adults who have experienced a mild or moderate traumatic brain injury (TBI). The goal is to see if these interventions can change how participants walk over a 12-week period. To be eligible, participants should be between 40 and 80 years old, have had a mild or moderate TBI within the last 3 months to 15 years, and be physically fit enough to exercise. They should also have normal vision, be able to communicate in English, and have reliable transportation if attending in person.

Participants can expect to engage in the study for 12 weeks, during which they will receive weekly phone calls from study staff and wear a wrist device (like a Fitbit) to track their activity. There is also an option to participate remotely for those who cannot travel. Before joining, potential participants will have a phone screening and an initial assessment to ensure they meet the eligibility criteria. This study aims to enhance understanding of how to support recovery in older adults after a TBI, and all types of backgrounds are welcome to participate.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • • Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment.
  • • \* TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI.
  • • If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity.
  • • Men and women of all ethnicities/races and socio-economic status.
  • • 40-80 years.
  • • Signed Informed consent.
  • • Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History \& Demographics Questionnaire. An affirmative response (i.e., \"yes\") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment.
  • • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
  • • Able to speak, read, and write English.
  • • Ambulatory without pain or the assistance of walking devices.
  • • Reliable means of transportation (if participating in Boston).
  • • No diagnosis of a neurological disease.
  • • No intracerebral brain bleeds.
  • • Access to a mobile device, laptop or desktop computer with internet access and Bluetooth.
  • Exclusion Criteria:
  • • Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach.
  • • Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  • • Not fluent in English.
  • • Undergoing any speech or physical therapy
  • • Not medically cleared for exercise.
  • • No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness)
  • • History of intracerebral brain bleeds or strokes.
  • • Neurological condition (MS, Parkinson's, Dementia, MCI).
  • • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events.
  • • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
  • • Regular use of an assisted walking device.

About Northeastern University

Northeastern University is a distinguished research institution located in Boston, Massachusetts, renowned for its commitment to advancing knowledge through innovative research and academic excellence. As a clinical trial sponsor, Northeastern leverages its interdisciplinary expertise and state-of-the-art facilities to foster groundbreaking studies in various fields, including health sciences, bioengineering, and public health. The university collaborates with industry partners and healthcare organizations to translate research findings into practical applications, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge. With a focus on ethical standards and rigorous methodologies, Northeastern University is dedicated to conducting high-quality clinical trials that address critical health challenges.

Locations

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0