NCT07038889

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

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Traumatic Brain Injury
• Stroke
• Gait Training

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-06-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study