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

Recruiting

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Indiana University · Participants: 30 · Started: Oct 9, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07038889

Locations in the U.S.

IndianaIndiana University Health, Neurorehabilitation & Robotics, Indianapolis

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.