Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Stroke Rehabilitation Assessment of Movement
研究概览
简要总结
Improving upper extremity movement and function in patients with stroke has been one of the primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had been first found by a domestic research group to be effective to facilitate sensory and motor recovery in patients with stroke within a month. However, the immediate and long-term effects of TS and the mechanism of brain plasticity in patients with stroke for more than three months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized controlled trial to investigate the immediate and long-term effects of TS in patients with stroke at subacute and chronic stages.
详细描述
The study was an assessor-blinded randomized controlled clinical trial. Participants with UE impairment for more than 3 months poststroke were randomly assigned to either the experimental (EXP) group or the control group. All participants received regular conventional rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT), and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks and 8 weeks post inception, and at one-month follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke;
- •stroke onset more than 3 months and less than 3 years prior to study enrollment;
- •no severe cognitive impairments and able to follow instructions;
- •the ability to sit on a chair for more than 30 minutes independently.
排除标准
- •musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
- •diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
- •speech disorder or global aphasia;
- •participating in any experimental rehabilitation or drug studies;
- •skin injuries, burns, or fresh scars at the sites of stimulation;
- •contraindication of heat or ice application.
结局指标
主要结局
Stroke Rehabilitation Assessment of Movement
时间窗: 3 months
Action Research Arm Test
时间窗: 3 months
Barthel Index
时间窗: 3 months
Modified Ashworth Scale
时间窗: 3 months
次要结局
未报告次要终点