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RECRUITING Not applicable ClinicalTrials.gov

Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07676578

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Walk-over-Ground (Device)
    Fully-immersive, real-world environments, overground gait therapy
  • C-Mill VR+ by Motek (Device)
    Semi-immersive, game-like environments, treadmill gait therapy

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Participants with uncontrolled cardiovascular, orthopedic, or metabolic conditions or unstable medication regimens that could interfere with their participation in the study. * Any comorbidity that could interfere with walking or gait training. * Participation in robot- or 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. * Any other condition deemed unsafe or confounding by investigator, such as pre-existing neurological conditions unrelated to stroke (e.g. Parkinson's, multiple sclerosis), unmanaged pain medications, or acute medical events during the screening period (e.g. recurrent stroke, hospitalization). * Individuals who score a 12 or higher on the Disability Rating Scale. * Recent Therapy: Participants should not have received physical therapy (PT) within the last month.

Conditions

Stroke

Locations

  • Indiana University Health, Neurorehabilitation & Robotics — Indianapolis, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record