The Effect of Electrical Stimulation Post Botulinum Toxin Injections on Functional Use of the Hemiparetic Upper Extremity
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of using electrical stimulation to improve upper extremity function in stroke survivors who receive botulinum toxin injections for spasticity. We hypothesize that individuals who receive the electrical stimulation could demonstrate improved benefit of the botulinum toxin injections and improved functional use of their weaker upper extremity.
详细描述
This is a pragmatic investigation that will utilize a two group comparison to compare electrical stimulation to a sham stimulation in individuals who are scheduled to receive botulinum toxin injections to their upper extremity for spasticity management. The electrical stimulation will be to the antagonist muscles of the injected muscles of the upper extremity and will be administered for 4 weeks post injections.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke, within first 6 months post stroke, have not previously received botulinum toxin injections for upper extremity spasticity, hemiplegic upper extremtity, able to communicate in English.
排除标准
- •contraindication for electrical stimulation (presence of implanted cardiac or other medical device, open wound on the wrist or hand, malignancy), fixed contracture of the elbow, wrist or hand, inability to follow simple directions, pregnancy.
结局指标
主要结局
Chedoke-McMaster Stroke Assessment Measure- Arm and Hand Recovery Stage
时间窗: Baseline, 1 month and 6 months after injections
Impairment level assessment to measure changes in active motor control and isolated movement in the upper extremity. The arm and the hand receive a separate score. The score ranges from 1 to 7. A higher score indicates better arm function.
次要结局
- Action Research Arm Test(Baseline, 1 month and 6 months)
- Modified Ashworth Scale for the Upper Extremity(Baseline, 1 month and 6 months)
- Motor Activity Log(Baseline, 1 month and 6 months after injections)
- Box and Block Test(Baseline, 1 month and 6 months after injections)
- Numeric Pain Rating Scale(Baseline, 1 month and 6 months)