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

Last updated: June 18, 2025
Sponsor: Indiana University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Traumatic Brain Injury

Memory Loss

Treatment

Walk-over-Ground

C-Mill VR+ by Motek

Clinical Study ID

NCT07038889
25423
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI) or stroke,confirmed by the referring neurologist.

  • Cognitive Function: Mini-Mental State Examination (MMSE) score greater than 24,indicating sufficient cognitive function to participate in the study.

  • Exercise Clearance: Approval from a neurologist for participation in exercise-basedinterventions.

  • Rehabilitation Need: Demonstrates a need for functional rehabilitation.

  • Recent Therapy: Participants should not have received physical therapy (PT) withinthe last month.

  • Consent: Must be able to provide informed consent for themselves.

Exclusion

Exclusion Criteria:

  • Participants with unstable medication regimens that could interfere with theirparticipation 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 followthe 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 withthe harness.

  • Functional Ambulation Category (FAC): Participants with an FAC score of less than 2indicate they require physical support from more than one person to walk.

Clarification:

  • The diagnosis of TBI or stroke can be confirmed by their neurologist or a physicaltherapist referring to the patient. If a physical therapist makes the referral, thediagnosis must still be officially confirmed by a neurologist to ensure it meets thestudy's medical criteria.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Walk-over-Ground
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
June 30, 2027

Study Description

After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.

First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.

During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.

Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.

Connect with a study center

  • Indiana University Health, Neurorehabilitation & Robotics

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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