Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
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: multi-sensory stimulation immersive VR+ treadmill training, treadmill training.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: 18 лет — 85 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients
Обзор
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
Подробное описание
This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.
The screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.
Baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment \[Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test\], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.
The intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
Preliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents.
Вмешательства
- Устройство multi-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group - Устройство treadmill training
Only treadmill training in treadmill training group
Первичные конечные точки
- Fugl-Meyer Assessment- Lower Extremity [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
Вторичные конечные точки (5)
- Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
- Berg balance scale [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
- 3D Gait Analysis - Affected Side Step Width [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
- Montreal Cognitive Assessment（MoCA） [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
- Mini-Mental State Examination (MMSE) [Срок оценки: 30 days (Adjust according to the actual situation of patients)]
Критерии участия
Критерии включения
- The first onset of stroke is diagnosed and confirmed according to the requirements of stroke
- The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34.
- 18-85 years of age.
- Able to walk with minor assistance
- MMSE score of 20-30 and ability to understand and follow instructions during the trial
- Able to sign an informed consent form.
Критерии исключения
- Severe visual or hearing impairments.
- Pregnant or breastfeeding women.
- Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.
- Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.
- History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.
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
Китай · 1 центр
- The First Affiliated Hospital of Chongqing Medical University, First Branch — Чунцин
Публикации
- Yang Z, Lu Q, Chen D, Tang L, Ran T, Yang L, Bai D. Multidimensional effects of virtual reality on motor dysfunction in patients who had a stroke: study protocol for a prospective, randomised, controlled clinical trial. BMJ Open. 2026 Apr 3;16(4):e108362. doi: 10.1136/bmjopen-2025-108362. PMID 41932701
Идентификаторы
NCT: NCT06275516 · 2024-208