Меню
Идёт набор NCT06864741

Virtual Reality Rehabilitation for Stroke Patients in the Hospital and at Home.

Без фазы С лечением Stroke Acute

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual reality guided motor rehabilitation.
Кому может быть актуально
Состояния в реестре: Stroke Acute. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.

Обзор

The goal of this clinical trial is to test whether a low-cost virtual reality (VR) motor rehabilitation platform can improve motor recovery in people recovering from a first-time ischemic stroke both in the hospital and at home. The study focuses on adults aged 18 and older who have experienced moderate to severe upper limb motor deficits. The main questions it aims to answer are: * Can VR-based motor therapy improve upper limb motor function compared to standard care? * Is VR-based motor therapy a feasible and acceptable treatment option for stroke patients? Researchers will compare patients receiving VR therapy to those receiving standard care to see if the VR therapy leads to greater improvements in motor recovery and more positive patient experiences. Participants will: * Complete standardized assessments of motor function and quality of life at multiple time points. * Participate in VR therapy sessions (if in the treatment group), using gamified activities designed to improve upper limb movement. * Provide feedback on their experience with the VR system, including ease of use, motion sickness, and engagement. This study will help determine whether VR-based rehabilitation can be a practical, effective way to improve access to therapy and recovery outcomes for stroke patients, especially in rural settings with limited rehabilitation resources.

Вмешательства

  • Поведенческое Virtual reality guided motor rehabilitation
    Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

Первичные конечные точки

  • Treatment effectiveness in hospital [Срок оценки: From enrollment to one week following the end of treatment at day 26]
  • Treatment effectiveness at home [Срок оценки: From enrollment through standard of care and VR treatment completion on Day 47]
  • Treatment feasibility - Motion Sickness [Срок оценки: From enrollment to one week following the end of treatment]
  • Treatment feasibility - Attitudes towards technology [Срок оценки: From enrollment to one week following the end of treatment]
  • Patient engagement at home [Срок оценки: From enrollment through standard of care and VR treatment completion on Day 47]
Вторичные конечные точки (7)
  • Treatment effectiveness - Motor performance [Срок оценки: From enrollment to one week following the end of treatment]
  • Treatment effectiveness - Quality of life [Срок оценки: From enrollment to one week following the end of treatment]
  • VR motor assessment validity [Срок оценки: From enrollment to one week following the end of treatment]
  • Gender differences in acceptance of VR rehabilitation technology [Срок оценки: From enrollment to one week following the end of treatment]
  • Independent use of home-based VR treatment [Срок оценки: From enrollment through standard of care and VR treatment completion on Day 47]
  • Performance characteristics of stroke patients [Срок оценки: From enrollment to last VR rehabilitation session]
  • Barriers to treatment adoption [Срок оценки: From enrollment to one week following the last VR session]

Критерии участия

Критерии включения

  • clinical diagnosis of first-time ischemic stroke involving the middle cerebral artery, confirmed by CT or MRI;
  • score between 6 and 40 on Fugl-Meyer Assessment's Upper Limb Extremity Subscore (FM - UE), indicating moderate to severe motor deficit;
  • ability and willingness to provide consent (score of 18 or more on the Montreal Cognitive Assessment) or assent (for scores lower than 18 on MoCA with consent provided by an authorized third party with the necessary legal authority to consent on behalf of patient)
  • INPATIENT ARM: less than 5 weeks since stroke onset with admission to Valley Regional Hospital in Kentville, NS, Canada
  • OUTPATIENT ARM: less than 3 months since stroke onset with discharge to home setting located within 1 hour drive of Valley Regional Hospital in Kentville, NS, Canada

Критерии исключения

  • brainstem, cerebellar or bilateral stroke lesion
  • a secondary neurological condition (e.g., Parkinson's disease)
  • musculoskeletal injuries interfering with task performance
  • an uncorrected visual deficit due to stroke or other etiologies
  • apraxia as identified by clinical assessment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Valley Regional Hospital — Kentville

Идентификаторы

NCT: NCT06864741 · 70851

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗