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Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Stroke Survivors

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors 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 stroke survivors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis: Anischemic or hemorrhagic stroke verified by imaging, confirmed by the patient's physician, and 1-6 months post-stroke (subacute phase)

• Motor Impairment Level: Functional Ambulation Category (FAC) 3-5, showing moderate impairment while still allowing safe participation in gait tasks.

• 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- and VR-based interventions.

• Rehabilitation Need: 10-Meter Walk Test \<1.0 m/s, as timed by a PT during screening, indicating a need for functional rehabilitation.

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

Locations
United States
Indiana
Indiana University Health, Neurorehabilitation & Robotics
RECRUITING
Indianapolis
Contact Information
Primary
Peter Altenburger, Ph.D., PT
paltenbu@iu.edu
317-278-0703
Backup
Hee-Tae Jung, Ph.D.
heetjung@iu.edu
317-278-1285
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2027-08
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Indiana University

This content was sourced from clinicaltrials.gov