Comparison of the Effectiveness of Two Different Types of Slings in Shoulder Subluxation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
The aim of this study is to investigate the effectiveness of shoulder slings on pain, motor function, daily life and balance in acute hemiplegic patients and to investigate whether different types of slings are superior to each other.
详细描述
Thirty-two patients with hemiplegic shoulder subluxation due to acute stroke were divided into two groups: shoulder supported slings and forearm supported slings. Hemiplegia rehabilitation passive and active-assistive range of motion, stretching, and neurophysiologic exercises were performed for all patients per day for 8 weeks.Pain assessment was performed with Visual Analog Scale, sensorimotor evaluation was performed with Fugl Meyer Assessment of Motor Function,daily life activities were assessed with Barthel Index, and balance was evaluated with Berg Balance Scale.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute patients who were independent and ambulatory prior to stroke and had their first stroke attack (<3 months)
- •Mini-mental Status Test (MMST) score ≥ 24,
- •Developing hemiplegia after stroke, standing independently for at least 2 minutes,
- •Lower limb being in stage 4-5 according to the Brunnstrom Approach (for ambulation and standard balance)
- •Upper limb being in stage 1-2 according to the Brunnstrom Approach
- •Spasticity 0-1+ according to Modified Ashworth scale
排除标准
- •Has a neurological history other than the diagnosis of hemiplegia (Parkinson's etc.)
- •Having used shoulder slings and orthosis.
- •Having a disease that can affect balance (cranial, etc.)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Change from Baseline Berg Balance Scale score at 8 weeks
Balance was evaluated with Berg Balance Scale. The minimum score is 0 and, the maximum score is 56. 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance.
Visual analog scale (VAS)
时间窗: Change from Baseline VAS score at 8 weeks
Pain assessment was performed with Visual Analog Scale after 8-weeks after treatment. Using a ruler, the score is determined by measuring the distance (mm) on the 100-mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Fugl-Meyer Assessment of Motor Recovery after Stroke
时间窗: Change from Baseline Fugl Meyer test score at 8 weeks
Sensorimotor evaluation was performed with Fugl-Meyer Assessment of Motor Recovery after Stroke. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Barthel Index
时间窗: Change from Baseline Barthel Index score at 8 weeks
Daily life activities were assessed with Barthel Index. The minimum score is 0, which indicates complete dependency and, the maximum score is 100 indicates complete independence.
次要结局
未报告次要终点