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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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 can…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Step Count
Timeframe: Continuous tracking from Screening to Week 10
2
Travel Distance
Timeframe: Continuous tracking from Screening to Week 10
3
Activity Zone Minutes
Timeframe: Continuous tracking from Screening to Week 10