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NCT07038889
Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Indiana University
Location: Indiana University Health, Neurorehabilitation & Robotics Indianapolis Indiana
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07038889). StuddyBuddy aggregates publicly available trial information.