The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia

Обзор

This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.

Вмешательства

• Устройство VR-WLC
  First, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later.
• Устройство CTL-VR
  First, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity.

Первичные конечные точки

• Change scores of Montreal Cognitive Assessment [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Stroop test [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Color trials test [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Frontal Assessment Battery [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]

Вторичные конечные точки (6)

• Change scores of Barthel Index [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of The Chinese Dementia-Quality of Life instrument, DQoL [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of The Cornell Scale for Depression in Dementia Chinese version [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Clinical Dementia Rating, CDR [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]
• Change scores of Behavioral and Psychological Symptoms of Dementia, BPSD [Срок оценки: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .]

Критерии участия

Критерии включения

• Age over 55 years;
• Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
• A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
• Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
• Able to walk independently and complete the Timed Up \& Go (TUG) test;
• Able to follow instructions with or without the assistance of a guardian or therapist;
• If the assessment indicates moderate dementia, further evaluation will be conducted to determine whether the participant has sufficient capacity to provide informed consent. If their capacity is found to be impaired, the study will be explained to their legal representative

Критерии исключения

• Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
• Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
• A psychiatric diagnosis of psychosis within the past six months.
• Diagnosis of Korsakoff syndrome.
• History of substance addiction.
• Severe hearing impairment or color blindness.
• History of severe vertigo or epilepsy.
• Concurrent participation in other studies that may affect cognitive function

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundat — New Taipei City

Идентификаторы

NCT: NCT07033468 · 202400517B0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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