Virtual reality could help TBI patients walk again
NCT ID NCT07038889
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This study tests whether a new, fully immersive virtual reality walking program can help people with traumatic brain injury (TBI) improve their mobility and quality of life. Thirty participants will try two types of VR therapy: one on a treadmill with screens, and another using a headset to walk over ground in realistic virtual environments. The goal is to see which approach is more effective and practical for real-world rehabilitation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virtual reality gait rehabilitation (C-Mill VR+ treadmill and HTC VIVE Focus Vision overground system)
- What this could lead to
- If successful, this could point toward a more effective, engaging way to help TBI patients regain walking ability and independence.
- What could go wrong
- This is a small, early feasibility study with only 30 participants, so results may not apply widely. The therapy is experimental and may not improve walking more than standard rehab.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gait training are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana, 46202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stroke rehabilitation with innovative extended reality (STRIVE): a feasibility study in clinical practice
- Health, functioning, work, and experiences of social and health services of persons with stroke
- Insights into impaired arm motor control on bilateral and unilateral functional activities after injury: a kinematic study
- Emergency stroke unit for acute cerebrovascular events: a prospective, single-arm trial with a historical control group
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients