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Search / Trial NCT07038889

Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)

Launched by INDIANA UNIVERSITY · Jun 18, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new type of rehabilitation program that uses virtual reality (VR) to help people who have had a traumatic brain injury (TBI) or stroke improve their walking skills. Unlike traditional treadmill therapies, this program uses immersive VR while walking over the ground, aiming to make walking practice feel more natural and effective. The goal is to see if this new VR therapy can better improve mobility and overall quality of life for those recovering from brain injuries.

To join the study, participants need to be between 65 and 74 years old, have a confirmed diagnosis of TBI or stroke, and have enough mental ability to follow instructions (measured by a simple test). They also need approval from their neurologist to safely take part in exercise and should not have had physical therapy in the last month. People with serious health issues that affect walking, those who have used VR gait therapy recently, or who might feel sick from VR won’t be eligible. Participants will be guided through VR walking sessions and closely monitored to see how well this new therapy helps them move better. This study is not yet recruiting, but it aims to offer a promising new way to support recovery after brain injury.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI) or stroke, confirmed by the referring neurologist.
  • Cognitive Function: Mini-Mental State Examination (MMSE) score greater than 24, indicating sufficient cognitive function to participate in the study.
  • Exercise Clearance: Approval from a neurologist for participation in exercise-based interventions.
  • Rehabilitation Need: Demonstrates a need for functional rehabilitation.
  • Recent Therapy: Participants should not have received physical therapy (PT) within the last month.
  • Consent: Must be able to provide informed consent for themselves.
  • Exclusion Criteria:
  • Participants with unstable medication regimens that could interfere with their participation in the study.
  • Any comorbidity that could interfere with walking or gait training.
  • Participation in VR-assisted gait training within the last 6 months.
  • Intolerance to virtual reality environments or motion simulation.
  • Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.
  • More than 135 kg total body weight.
  • More than 2.00 meters in body height.
  • Presence of open skin lesions or bandages in areas that would come into contact with the harness.
  • Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.
  • Clarification:
  • - The diagnosis of TBI or stroke can be confirmed by their neurologist or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a neurologist to ensure it meets the study's medical criteria.

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Hee-Tae Jung, Ph.D.

Principal Investigator

Indiana University, Luddy School of Informatics, Computing, and Engineering

Peter Altenburger, Ph.D., PT

Principal Investigator

Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported