Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Step Count [Срок оценки: Continuous tracking from Screening to Week 10]
• Travel Distance [Срок оценки: Continuous tracking from Screening to Week 10]
• Activity Zone Minutes [Срок оценки: Continuous tracking from Screening to Week 10]

Вторичные конечные точки (9)

• 10-Meter Walk Test [Срок оценки: Baseline, Week 7, Week 10]
• 6-Minute Walk Test [Срок оценки: Baseline, Week 7, Week 10]
• Dynamic Gait Index [Срок оценки: Baseline, Week 7, Week 10]
• Timed Up and Go Test [Срок оценки: Baseline, Week 7, Week 10]
• Step-Over Test [Срок оценки: Baseline, Week 7, Week 10]
• Step Length [Срок оценки: Baseline, Week 7, Week 10]
• Stride Length [Срок оценки: Baseline, Week 7, Week 10]
• Stance Percentage [Срок оценки: Baseline, Week 7, Week 10]
• Gait Speed [Срок оценки: Baseline, Week 7, Week 10]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Indiana University Health, Neurorehabilitation & Robotics — Indianapolis

Идентификаторы

NCT: NCT07676578 · 31406 · 1R03HD120509-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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