Effects of Different Virtual Reality Task-Oriented Physical Activities on Physical Function and Brain Reorganization in Adults With Mental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Box and Block Test
研究概览
简要总结
The goal of this clinical study was to examine the effects of virtual reality task-oriented physical activity on physical and task performance and brain activity in adults with mental disabilities. The main questions it aimed to answer were:
- Does participation in virtual reality task-oriented physical activity lead to different changes in physical and task performance over time compared with usual work, rehabilitation, and daily activities?
- Does participation in virtual reality task-oriented physical activity lead to different changes in brain activity over time compared with usual work, rehabilitation, and daily activities?
Researchers compared participants who received the additional task-oriented physical activity training program with participants who continued their usual work, rehabilitation, and daily activities without additional training.
Participants in the intervention group:
- Participated in task-oriented physical activities using interactive video game-based activities and video-guided exercise.
- Completed training sessions three times per week.
- Completed assessments of physical and task performance and brain activity before and after the intervention and during follow-up.
Participants in the control group continued their usual work, rehabilitation, and daily activities and completed the same assessments over time.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Aged 20 years or older.
- Had a Category I disability certification and a medical diagnosis of intellectual disability or persistent severe mental illness.
- Diagnosis of intellectual disability or persistent severe mental illness for more than 1 year.
- Mini-Mental State Examination (MMSE) score greater than 18.
- Able to understand and follow verbal instructions and cooperate with the training and assessment procedures.
- Able to walk independently for at least 10 meters without an assistive device.
- Able to stand independently for at least 3 minutes without an assistive device or physical assistance and without falling.
- No stroke or other systemic chronic disease within the previous 6 months.
- No musculoskeletal injury within the previous 6 months that resulted in substantial cognitive or motor impairment.
排除标准
- Stroke or brain injury within the previous 6 months.
- Severe systemic disease, such as severe diabetes or heart disease, that substantially affected daily functioning.
- Mini-Mental State Examination (MMSE) score of 18 or lower.
- Unable to follow verbal instructions.
- Unable to cooperate with the training or assessment procedures.
研究组 & 干预措施
Experimental Group
Participants in this arm received the additional task-oriented physical activity training program in addition to their usual work, rehabilitation, and daily activities.
干预措施: Virtual Reality Task-Oriented Physical Activity Training (Behavioral)
Control Group
Participants in this arm continued their usual work, rehabilitation, and daily activities without receiving the additional task-oriented physical activity training program.
结局指标
主要结局
Box and Block Test
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Gross manual dexterity was assessed using the Box and Block Test (BBT). The outcome was the number of blocks transferred from one compartment of a box to the other within 60 seconds. Two trials were performed at each assessment, and the mean number of blocks transferred across the two trials was used for analysis. A higher score indicated better gross manual dexterity.
Functional Reach Test
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Functional balance was assessed using the Functional Reach Test (FRT). The outcome was the maximum distance the participant could reach forward while maintaining a fixed base of support, measured in centimeters. A greater reach distance indicated better functional balance.
Timed Up and Go Test
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Functional mobility was assessed using the Timed Up and Go Test (TUG). The outcome was the time required to stand up from a chair, walk 3 meters, turn, walk back to the chair, and sit down, measured in seconds. Shorter completion time indicated better functional mobility.
General Self-Efficacy Scale
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Self-efficacy was assessed using the 10-item General Self-Efficacy Scale (GSES). Each item was rated on a 4-point Likert scale, yielding a total score ranging from 10 to 40. Higher scores indicated greater perceived self-efficacy.
Grooved Pegboard Test
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Fine manual dexterity and visuomotor performance were assessed using the Grooved Pegboard Test (GPT). The outcome was completion time, measured in seconds. Two trials were performed at each assessment, and the mean completion time of the two trials was used for analysis. Shorter completion time indicated better performance.
Color Trails Test 1
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Visual attention, visual search, and sequential processing were assessed using the Color Trails Test 1 (CTT1). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Color Trails Test 2
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Cognitive flexibility, alternating sequencing, and visual attention were assessed using the Color Trails Test 2 (CTT2). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Electroencephalographic Activity During Task Performance
时间窗: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Brain activity was assessed using electroencephalography (EEG) during task performance. EEG signals were recorded to evaluate longitudinal changes in brain activity associated with the intervention, with particular interest in activity over frontal, sensorimotor, and parietal regions. Frequency-specific EEG activity was examined to characterize changes in neural activity over time.
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07844525
- 其他研究编号
- 202301HM001, NSTC 112-2410-H-003-138-MY2
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data are not planned to be shared because a formal data-sharing plan was not established for this study.