Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
研究概览
简要总结
Congenital or acquired neurological disorders could lead to consistent motor and cognitive disabilities. The continuity and persistency of a tailored home rehabilitation protocol after recovery is crucial to prevent disease aggravation or relapses. The integration of a web-based new technology in home rehabilitation programme can constitute a functional low cost resource by offering patients off-line (and on-line) monitoring and by proposing new motivating ways of rehabilitation through high tech tools such as serious games.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range 18-85
- •Parkinson Disease (PD - mild to moderate) in stable treatment for at least 3 months
- •Multiple Sclerosis (MS) without relapses in the last 3 months (EDSS ≤ 6)
- •post stroke ( ≥ 6 months after the acute event)
排除标准
- •Mini Mental State Examination < 20
- •limited range of motion
- •severe pain
- •severe deficit of visual acuity or auditory perception or communication and severe dysmetry
研究组 & 干预措施
Usual care program
usual care program
干预措施: Usual care program (Other)
HEAD Rehabilitation
rehabilitation with IT multimedial devices
干预措施: Multimedial Rehabilitation (Other)
结局指标
主要结局
Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
时间窗: change from baseline after 4 months and after 7 months
Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)
时间窗: change from baseline after 4 months and after 7 months
Endurance assessed on two-minute walking test (2MWT)
时间窗: change from baseline after 4 months and after 7 months
Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)
时间窗: change from baseline after 4 months and after 7 months
次要结局
- Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)(change from baseline after 4 months and after 7 months)
- Finger dexterity assessed on 9-Hole Peg Test (9HPT)(change from baseline after 4 months and after 7 months)
- Attention and concentration assessed on Attention and Concentration test(change from baseline after 4 months and after 7 months)
- Walking speed assessed on 10-Meter Walking Test (10MWT)(change from baseline after 4 months and after 7 months)
- Static balance and fall risk assessed on Berg Balance Scale (BBS)(change from baseline after 4 months and after 7 months)
- Strength in upper and lower extremities assessed on Motricity Index (MI)(change from baseline after 4 months and after 7 months)
- Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire(change from baseline after 4 months and after 7 months)
- Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)(change from baseline after 4 months and after 7 months)