RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07038889

Registry updated: 2026-10-15

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Description

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.

Interventions

C-Mill VR+ by Motek (Device)
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
Walk-over-Ground (Device)
This intervention utilizes the HTC VIVE Focus Vision 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.

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.

Conditions

Traumatic Brain Injury

Locations

Indiana University Health, Neurorehabilitation & Robotics — Indianapolis, Indiana, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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