Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)
Starting soon · Not applicable
Conditions studied: Traumatic Brain Injury
In brief
The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.
Key facts
- Study ID
- NCT07038889
- Run by
- Indiana University
- People needed
- 30
- Starts
- 2026-07-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.
- Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.
- Exercise Clearance: Approval from a physician 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.
You may not qualify if…
- 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 can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.
Where it is running
- Indiana University Health, Neurorehabilitation & Robotics — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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