Protocol for a Single-blind Randomized Controlled Clinical Trial to Investigate the Feasibility and Safety of In-bed Self-exercise Based on Electromyography Sensor Feedback in Patients With Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change of Pittsburgh Rehabilitation Participation Scale
研究概览
简要总结
The goal of this to investigate the feasibility and safety of in-bed self-exercises based on EMG-sensor feedback in subacute stroke patients. The main question is feasibility and safety. It aims to answer are:
[Pittsburgh Rehabilitation Participation Scale] [The number and percentage of participating sessions] [The number and percentage of completed sessions] [The number and percentage of successful sessions] [The mean amplitude of muscle contractions in a session] [The duration and percentage of participating sessions during self-exercise] [Rivermead motor assessment] [Manual muscle test] [brunnstrom stages of motor recovery] [Fugl Meyer assessment of lower extremity] [Berg balance scale] [Functional ambulation category] [modified Rankin scale] [modified Barthel index] [Short-form Health Survery 36 version 2]
详细描述
The intervention group is provided with graded exercise using the in-bed self-exercises based on EMG-sensor feedback according to muscle strength of the hemiplegic lower extremity and Brunnstrom stages of motor recovery in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
An outcome assessor will be blinded after assignment to interventions by blocking access to the web randomization table operated on the website.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years and older
- •the onset of the stroke is less than 3months ago
- •Lower extremity weakness due to stroke (MMT =< 4 grade)
- •Modified Rankine Scale 2-5 points
- •Cognitive ability to follow commands
排除标准
- •stroke recurrence
- •other neurological abnormalities (e.g. parkinson's disease).
- •severely impaired cognition
- •serious and complex medical conditions(e.g. active cancer)
- •cardiac pacemaker or other implanted electronic system
结局指标
主要结局
Change of Pittsburgh Rehabilitation Participation Scale
时间窗: baseline-3weeks
The PRPS is a clinician-assessed instrument designed to assess patient participation in treatment. It is rated on a scale of 1 to 6 to measure the patient's effort and activeness to participate in treatment. Score '6' if the patient participated in all exercises and ' 1' if the patient refused the entire session. The PRPS had high interrater reliability(ICC=.96).
次要结局
- Change of Rivermead motor assessment(baseline-3weeks-12weeks)
- Change of The number and percentage of participating sessions(baseline-3weeks)
- Change of The number and percentage of completed sessions(baseline-3weeks)
- Change of The number and percentage of successful sessions(baseline-3weeks)
- Change of The mean amplitude of muscle contractions in a session(baseline-3weeks)
- Change of Manual muscle test(baseline-3weeks-12weeks)
- Change of Modified Barthel index(baseline-3weeks-12weeks)
- The duration and percentage of participating sessions during self-exercise(baseline-3weeks)
- Change of Berg balance scale(baseline-3weeks-12weeks)
- Change of Brunnstrom stages of motor recovery(baseline-3weeks-12weeks)
- Change of Functional ambulation category(baseline-3weeks-12weeks)
- Change of Fugl-Meyer assessment of lower extremity(baseline-3weeks-12weeks)
- Change of modified Rankin scale(baseline-3weeks-12weeks)
- Change of Short-form Health Survery 36 version 2(baseline-3weeks-12weeks)