Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
研究概览
简要总结
The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder pain.
详细描述
The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board supports has been used to prevent shoulder pain and could be recommended for wheelchair users to keep normal position. Therefore, the investigators designed the equipment wheelchair handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement of upper limb function and increase of the quality of life.The aim of this study was to evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation training for people with hemiplegic shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment"
- •Course of disease range from two weeks to six months
- •Age range from 20 to 85 years old
- •Brunnstrom scale range from I to II
- •Good mental status and could be able to answer questions
排除标准
- •Patients with brain trauma, thalamic lesions or peripheral neuropathy
- •Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain
- •Patients get worse as a result of cerebral edema or coma following stroke
- •Patients with serious infection or disorder in heart, liver and kidney
- •Patients withdraw from the research by themselves
结局指标
主要结局
Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
时间窗: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
0-66, with higher scores indicating higher function of movement.UE-FM was a well-established stroke motor measure, iteratively determining active movement at each joint of the upper extremity. The UE-FM items were organized into scales that discern isolated movements at increasingly distal upper extremity regions.
次要结局
- Change of Quality of Life Index (QLI)(Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.)
- Change of Visual Analogue Pain Scale (VAS)(Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.)
- Change of Modified Barthel Index (MBI)(Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.)