Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).
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
- Triple (Participant, Care Provider, 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
- •Between 18 and 80 years of age
- •Within 1-12 months of ischemic or hemorrhagic stroke
- •First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
- •Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
- •Able to understand instruction
排除标准
- •Serious cardiovascular or respiratory diseases
- •Skin lesions, infections or other skin problems
- •Serious circulatory problems such as deep vein thrombosis
- •Allergies or significant discomfort to pressure garment materials
- •Upper extremity fractures or severe joint problems
- •Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: Baseline, Week 4. Week 8
A classic tool used to assess the rehabilitation process of stroke patients from the aspects of sensorimotor function and level of life activities. It has two main domains, i.e., upper extremity and lower extremity. The 33-item upper extremity domain that will be used in this study includes the range of motion of the shoulder, elbow, wrist, and fingers as well as elements such as grip strength and hand coordination. Scored between 0 and 66, higher scores indicating greater function.
次要结局
- Modified Ashworth Scale (MAS)(Baseline, Week 4. Week 8)
- Visual Analogue Scale (VAS)(Baseline, Week 4. Week 8)
- Box and Block Test (BBT)(Baseline, Week 4. Week 8)
- Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure(Baseline, Week 4. Week 8)
- 36-Item Short Form Health Survey (SF-36)(Baseline, Week 4. Week 8)