Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)
NCT ID: NCT07038889
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-01-01
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VR-Assisted Overground Gait Therapy
Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Pro 2, enabling participants to practice walking in real-world environments and gait tasks.
Walk-over-Ground
This intervention utilizes the HTC VIVE Pro 2 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.
Conventional Treadmill-Based VR Gait Therapy
Participants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens.
C-Mill VR+ by Motek
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
Interventions
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Walk-over-Ground
This intervention utilizes the HTC VIVE Pro 2 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.
C-Mill VR+ by Motek
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
Eligibility Criteria
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Inclusion Criteria
* 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-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
* 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 or stroke can be confirmed by their neurologist or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a neurologist to ensure it meets the study's medical criteria.
18 Years
ALL
No
Sponsors
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Indiana University Health
OTHER
Indiana University
OTHER
Responsible Party
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Hee-Tae Jung
Assistant Professor, Health Informatics
Principal Investigators
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Hee-Tae Jung, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University, Luddy School of Informatics, Computing, and Engineering
Peter Altenburger, Ph.D., PT
Role: PRINCIPAL_INVESTIGATOR
Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
Locations
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Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25423
Identifier Type: -
Identifier Source: org_study_id