Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

Официальное название

A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

Обзор

This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.

Подробное описание

This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.

In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.

In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).

In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.

Вмешательства

• Устройство immersive VR pathfinding training
  Pathfinding training with immersive VR.
• Другое Occupational therapy
  Only receive conventional cognitive training group

Первичные конечные точки

• Mental State Examination Scale (MMSE) [Срок оценки: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]
• Brain functional activation (fNIRS) [Срок оценки: 1. finished in 3 days before training. 2. finished 3 days after 30-days training]

Критерии участия

Критерии включения

• Diagnosis of stroke by neuroimaging (CT or MRI) assessment
• 18-85 years old
• Be able to follow instructions to complete the test
• Can tolerate the rehabilitation training of this experiment
• First stroke
• Patients who signed informed consent

Критерии исключения

• The test could not be tolerated due to organic disease
• There is a serious mental illness resulting in inability to cooperate with or tolerate this test
• is participating in another clinical trial involving an investigational drug or physical therapy
• Patients who have not signed informed consent

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06704360 · 20241120

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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