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Набор скоро начнётся NCT07506486

Effect of Immersive Virtual Reality Cognitive Rehabilitation on Subacute Stroke Patients (A Pilot Study)

Без фазы С лечением Stroke (Subacute)

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: Immersive Virtual Reality System, Conventional Paper-and-Pencil Cognitive Training.
Кому может быть актуально
Состояния в реестре: Stroke (Subacute). Базовые параметры: 18 лет — 59 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
Индонезия
Следующий шаг
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Официальное название

Effect of Cognitive Rehabilitation Using Immersive Virtual Reality on Cognitive Function and Functional Activity of Subacute Stroke Patients: A Pilot Randomized Controlled Trial

Обзор

This pilot randomized controlled trial aims to evaluate the effectiveness of cognitive rehabilitation using an immersive Virtual Reality (VR) system compared to conventional paper-and-pencil cognitive training in subacute stroke patients. A total of 22 participants will be randomly assigned to either the VR intervention group (n=11) or the conventional control group (n=11). The study will measure changes in cognitive function and functional independence

Подробное описание

Cognitive impairment is a common and debilitating consequence of stroke that hinders functional recovery. This pilot study investigates immersive Virtual Reality (VR) as a novel, engaging modality for cognitive rehabilitation in subacute stroke patients.

Twenty-two eligible subacute stroke patients treated at Dr. Hasan Sadikin General Hospital will be recruited and randomized into two parallel arms. The experimental group (n=11) will receive cognitive rehabilitation using an immersive VR system, while the active control group (n=11) will receive conventional cognitive rehabilitation using standardized paper-and-pencil tests. Both interventions will be administered alongside standard stroke rehabilitation care. Assessments will be conducted at baseline and post-intervention to evaluate cognitive improvement using the Indonesian version of the Montreal Cognitive Assessment (MoCA-INA) and functional activity using the Functional Independence Measure (FIM).

Вмешательства

  • Устройство Immersive Virtual Reality System
    Intervention Description: Treatment Method: Participants will wear a fully immersive VR headset to engage in interactive, gamified virtual environments specifically designed to stimulate cognitive domains (memory, attention, visuospatial, and executive functions). Duration \& Frequency: Each VR session will last for \[30 to 45 minutes\]. The treatment will be administered at a frequency of \[3 sessions per week\] for a total duration of \[8 consecutive weeks\]. Standard Care: This intervention
  • Поведенческое Conventional Paper-and-Pencil Cognitive Training
    Intervention Description: Treatment Method: Participants will perform standardized paper-and-pencil tasks, puzzles, and therapeutic worksheets guided by a therapist, targeting identical cognitive domains (memory, attention, visuospatial, and executive functions) as the experimental group. Duration \& Frequency: Each conventional session will last for \[30 to 45 minutes\] to match the experimental arm. The treatment will be administered at a frequency of \[3 sessions per week\] for a total durat

Первичные конечные точки

  • Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA) [Срок оценки: Baseline and Post-Intervention (Week 8)]
  • Change in Functional Activity Assessed by Functional Independence Measure (FIM) [Срок оценки: Baseline and Post-Intervention (Week 8)]

Критерии участия

Критерии включения

  • Male or female aged 40-59 years old
  • Stroke patient 2-4 months onset of stroke
  • Burnstorm stage V or above
  • First-time stroke that has been diagnosed by a neurologist with CT scan and/or MRI
  • Stroke risk factors and comorbidities are controlled with medication
  • Mild and moderate level of cognitive impairment based on MOCA and can use devices
  • Participants can grip and operate VR console with their hand
  • Participants can follow instructions and exercises
  • Participants were cooperative and willing to participate in the study by signing a consent form after receiving an explanation.

Критерии исключения

  • Participants with severe cognitive impairment or aphasia struggle to understand instructions
  • Neglected patient
  • Participants with low vision unable to perceive content on screens
  • Participant with eyestrain characterized by blurring vision, dry eyes, foreign body sensation, itching watering, neck stiffness and backache
  • Severe musculoskeletal disorders causing problem in standing and following instruction

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

Индонезия · 1 центр
  • RSUD Majalengka — Majalengka

Идентификаторы

NCT: NCT07506486 · IKFR-202603.02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗