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Набор по приглашению NCT07183033

Exploratory Trial of VR Intervention on Neuroplasticity in Older Adults With Cognitive Frailty

Без фазы С лечением Cognitive Frailty

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: VR-Based Resistance Training Intervention, Standardized Leg-Raising Training.
Кому может быть актуально
Состояния в реестре: Cognitive Frailty. Базовые параметры: от 60 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
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Официальное название

Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty

Обзор

To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty.

Подробное описание

This study is designed as a prospective, parallel-group, single-blind randomized controlled trial to be conducted at a senior care institution in Beijing from August to September 2025. Older adults with cognitive frailty will be randomly allocated using a computer-generated random sequence concealed in opaque sealed envelopes to either a VR-based intervention group or a control group. Allocation concealment will be maintained throughout the trial, and research staff responsible for data collection, assessment, and analysis will remain blinded to group assignments.

The intervention will comprise task-oriented VR activities specifically designed to stimulate cognitive and sensorimotor processes. Functional near-infrared spectroscopy (fNIRS) will be utilized to evaluate pre- and post-intervention neural activity, with a focus on cortical activation patterns, changes in network efficiency, and modulation of functional pathways.

This study aims to generate exploratory evidence regarding the mechanisms underlying VR-induced neuroplasticity in this population, thereby establishing a foundation for optimizing intervention parameters and targeting specific brain regions in subsequent large-scale trials.

Вмешательства

  • Поведенческое VR-Based Resistance Training Intervention
    Participants in the intervention group will engage with a self-developed VR resistance training program entitled "Kitten Crossing the Bridge." This program is designed to guide older adults through static lower-limb resistance exercises, while integrating rhythm control, spatial judgment, and visual feedback. The intervention will be administered over 4 weeks, with two sessions per week; each session will last approximately 20 minutes (excluding equipment setup and rest periods). All training se
  • Поведенческое Standardized Leg-Raising Training
    Participants in the control group will implement a standardized leg-raising exercise protocol, which is designed to match the intensity and rhythm of the VR-based intervention. Training will be guided by pre-recorded verbal prompts and demonstration videos developed by the research team, ensuring procedural uniformity. Each session will last approximately 20 minutes (excluding equipment setup and rest periods), with two sessions per week over a 4-week duration. All sessions will be supervised by

Первичные конечные точки

  • fNIRS [Срок оценки: Baseline, 2 Weeks, 4 Weeks]
Вторичные конечные точки (2)
  • Cognitive function [Срок оценки: Baseline, 4 Weeks]
  • Frailty [Срок оценки: Baseline, 4 Weeks]

Критерии участия

Критерии включения

  • Frailty Phenotype (FP) score between 1 and 5
  • Subjective Cognitive Decline Questionnaire (SCD-Q9) score ≥ 5
  • Montreal Cognitive Assessment (MoCA) score between 15 and 25
  • Activities of Daily Living (ADL) score ≤ 26
  • Age ≥ 60 years
  • Submit written informed consent prior to participating in the study

Критерии исключения

  • Clinical diagnosis of Alzheimer's disease, other dementias, or neuropsychiatric disorders (e.g., cerebrovascular disease, Parkinson's disease, history of traumatic brain injury, brain tumors, epilepsy)
  • Current use of medications or addictive substances that may impair cognition
  • Presence of musculoskeletal disorders (e.g., osteoarthritis, fractures), cardiovascular disease, or liver/kidney dysfunction that prevent safe participation in exercise
  • Severe sensory or speech impairments that hinder communication
  • Severe motion sickness or vestibular disorders

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
Открытое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College — Пекин

Идентификаторы

NCT: NCT07183033 · 2025-248

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗