Overground VR Gait Rehab for Traumatic Brain Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests an immersive overground virtual reality gait rehabilitation program for individuals with traumatic brain injury. Participants are randomized to receive 12 sessions of VR-based overground gait therapy or a comparator involving non-immersive treadmill VR therapy (C-Mill) over six weeks. Wearable activity trackers are used to establish baseline activity, with outcomes assessed before, after, and one month post-intervention. Eligibility requires documented TBI, adequate cognitive function, medical clearance for exercise, and no recent physical therapy or VR gait training. The trial is led by Indiana University with collaboration from Indiana University Health, at the Neurorehabilitation & Robotics center in Indianapolis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Health, Neurorehabilitation & Robotics
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Hee-Tae Jung, Ph.D. — Indiana University, Luddy School of Informatics, Computing, and Engineering
• Study coordinator: Peter Altenburger, Ph.D., PT
• Email: paltenbu@iu.edu
• Phone: 317-278-0703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.