Strategies for Recovery of Dexterity Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- For Phase 2: Change in Hand function
研究概览
简要总结
Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke.
详细描述
The purpose of this study is to develop, refine and test the 'alternate hand training strategy' to facilitate adaptation, repetition and relearning to restore hand function after stroke. The three aims are: to restore adaptation (Aim 1), facilitate grasp efficiency and normal directional biases during repetition (Aim 2), and enhance the rate of learning to improve hand function and quality of life post stroke (Aim 3).
Hypotheses: We hypothesize that alternate hand training will increase the rate of learning and lead to greater improvement in hand function. The results will inform dosing of therapy for optimal relearning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to read/write in English
- •Age > 18 yrs
- •Radiologically verified stroke > 4 months old (3T structural MRI)
- •Moderate arm motor impairment (Fugl-Meyer Scale < 60/66)
- •Ability to reach, grasp and lift the test objects with the affected side as assessed by the PI
- •Willingness to complete all clinical assessments and MRI, and comply with training protocols
- •Ability to give informed consent and HIPPA certificationsPlease list all exclusion criteria for study:
排除标准
- •Sensorimotor impairments in the unaffected hand
- •Severe visual or sensory impairment, including neglect on the affected side
- •Significant cognitive dysfunction (score < 24 on Folstein's Mini Mental Status Examination)
- •Severe or unstable spasticity on treatment with Botulinum toxin or intrathecal baclofen
- •Depression (Geriatric Depression Scale score <11)
- •Major disability (modified Rankin Scale > 4)
- •Previous neurological illness, complicated medical condition, or significant injury to either upper extremity
结局指标
主要结局
For Phase 2: Change in Hand function
时间窗: 6 weeks
Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.
For Phase 1: Adaptation of fingertip forces and movements during grasping.
时间窗: 6 weeks
5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.
次要结局
- Phase 2 - Maintenance of hand function(6 weeks after end of training)