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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07038889
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 26, 2025
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Focus Vision, enabling participants to practice walking in real-world environments and gait tasks.
  • Active Comparator: 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.

Primary Outcome Measure

Step Count [ Time Frame: Continuous tracking from Screening to Week 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Health, Neurorehabilitation & RoboticsIndianapolisIndiana46202
Peter Altenburger, Ph.D., PT
[email protected]
317-278-0703
Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS
[email protected]
317-963-7050
Peter Altenburger, Ph.D., PT (PRINCIPAL_INVESTIGATOR)
Hee-Tae Jung, Ph.D. (SUB_INVESTIGATOR)

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