Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- fNIRS
研究概览
简要总结
To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VR-Based Resistance Training Intervention
Participants in the intervention group will receive training using a self-developed VR-based resistance training system named "Kitten Crossing the Bridge." This system primarily emphasizes static lower-limb resistance control and integrates mechanisms of task rhythm regulation, spatial judgment, and visual feedback. Preliminary usability testing has demonstrated good immersion, safety, and acceptability among older adults.The intervention will last for 4 weeks, with two sessions per week; each session will last approximately 20 minutes (excluding device setup and rest intervals). All sessions will be supervised by trained staff to ensure safety and provide necessary assistance.
干预措施: VR-Based Resistance Training Intervention (Behavioral)
Standardized Leg-Raising Training
Participants in the control group will perform standardized leg-raising exercises. The training rhythm will be guided by pre-recorded verbal prompts and demonstration videos developed by the research team, ensuring that the exercise intensity and pace are aligned with those of the intervention group.
干预措施: Standardized Leg-Raising Training (Behavioral)
结局指标
主要结局
fNIRS
时间窗: Baseline, 2 Weeks, 4 Weeks
Neural activity during the intervention tasks will be recorded using a functional near-infrared spectroscopy (fNIRS) imaging system. A 24-channel NirLight fNIRS device (Huairui Medical Technology Co., Ltd., China) will be employed, with light sources operating at wavelengths of 760-850 nm and a sampling rate of 10 Hz. The probe configuration will primarily cover the frontal, parietal, and parts of the temporal and occipital lobes.
次要结局
- Cognitive function(Baseline, 4 Weeks)
- Frailty(Baseline, 4 Weeks)
研究者
Zheng Li
Professor
Peking Union Medical College