NCT07676578 Overground Virtual Reality (VR) Gait Rehabilitation for Stroke
| NCT ID | NCT07676578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hee-Tae Jung, Ph.D.
PRINCIPAL INVESTIGATOR
Indiana University, Luddy School of Informatics, Computing, and Engineering
Frequently Asked Questions
Who can join the NCT07676578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07676578 currently recruiting?
Yes, NCT07676578 is actively recruiting participants. Contact the research team at paltenbu@iu.edu for enrollment information.
Where is the NCT07676578 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07676578 clinical trial?
NCT07676578 is sponsored by Indiana University. The principal investigator is Hee-Tae Jung, Ph.D. at Indiana University, Luddy School of Informatics, Computing, and Engineering. The trial plans to enroll 30 participants.
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