Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT07038889
- Status
- Not Yet Recruiting
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Conditions
- Gait Training
- Stroke
- Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- C-Mill VR+ by Motek — DEVICEParticipants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
- Walk-over-Ground — DEVICEThis intervention utilizes the HTC VIVE Pro 2 system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities.
Study Details
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 Dates
- Start date
- Jun 30, 2026
- Status verified
- Dec 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VR-Assisted Overground Gait TherapyParticipants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Pro 2, enabling participants to practice walking in real-world environments and gait tasks.
- Active Comparator: Conventional Treadmill-Based VR Gait TherapyParticipants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens.
Primary Outcome Measure
Step Count [ Time Frame: Continuous tracking from Screening to Week 10 ]
Central Contacts
- Peter Altenburger, Ph.D., PT317-278-0703
- Hee-Tae Jung, Ph.D.317-278-1285
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University Health, Neurorehabilitation & Robotics | Indianapolis | Indiana | 46202 | Peter Altenburger, Ph.D., PT (PRINCIPAL_INVESTIGATOR) Hee-Tae Jung, Ph.D. (SUB_INVESTIGATOR) |
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