Neurorehabilitation Of The Hand Post Stroke Using The Myhandtm System In A Sub-Acute Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Efficacy of the IRegained MyHandTM System and assessment of objective & subjective changes as a result of the hand function training
研究概览
简要总结
IRegained aims to train stroke survivor participant’s hands using the IRegained MyHandTM System with the objective of improving hand and finger function. The system provides passive resistance and allows participants to perform targeted grasp functions at varying resistances as per their ability. The training will involve exercises to train individual finger function, and grasping tasks such as the pinch, tripod, quadripod and spherical grasp. To improve motor function, the training will target both the intrinsic and extrinsic musculature of the hand.
Consented participants will undergo hand function training 3 days per week over a 6-week period, with each participating patient receiving 18 sessions of hand function training (minumum of 16 sessions).
The project will investigate a) the efficacy of the IRegained MyHandTM System in training hand function in individuals post stroke and b) observe objective and subjective changes in hand function as a result of hand-function training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Unilateral upper limb impairment caused by a single stroke at least 2 weeks to 6 months prior to the start of the study.
- •Healthy (or corrected-to-normal) vision and hearing abilities to understand the information communicated by the research investigators.
- •Ambulatory, and/or able to travel to research study location.
- •CMSA: Level 3 or greater for hand function, and Shoulder pain
- •MMSE score ≥ 24
- •Capacity to consent is established.
排除标准
- •Diagnosis of a neurological disorder other than stroke that can impede in hand function therapy (e.g. peripheral neuropathy, myopathies, Parkinson’s disease etc.)
- •Participants suffering from osteoarthritis or other musculoskeletal or neuromuscular disorders that affect hand function.
- •Participants with severe systemic disease that has an impact on hand function
- •Participants with severe spasticity or contractures, that has a limiting impact on hand function therapy.
结局指标
主要结局
Efficacy of the IRegained MyHandTM System and assessment of objective & subjective changes as a result of the hand function training
时间窗: 16 to 18 sessions of training
次要结局
- To observe objective and subjective changes in hand function as a result of hand-function training(16 to 18 sessions of training)