Effictiveness of Multichannel Functionnal Electrical Motor and Sensorimotor Stimulation for Subchronic Stroke Gait Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Change in walking speed at intermediate evaluation
研究概览
简要总结
The goal of this interventional study is to evaluate the effect of multichannel functionnal electrical stimulation for subchronic stroke gait rehabilitation. The main questions it aims to answer are:
- Does this new therapy help improve walking speed?
- Evaluate other aspects of therapeutic effectiveness such as different aspects of walking endurance, mobility, postural instability and autonomy.
- Evaluate physiological aspects of autonomous gait such as spasticity, muscle strength and motor and sensorimotor recovery.
- Evaluate the acceptability of this new therapy and its effect on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •First ischemic stroke or first hemorrhagic supratentorial stroke
- •Stroke must be unique
- •Stoke event in the last 12 months but no sooner than 6 months (post subchronic stroke phase)
- •Able to walk with the support of one person and one or multiple walking aids (new functionnal ambulatory classification equal to 1, 2 or 3)
- •Able to tolerate and respond to electrical stimulation(Muscle strength grading level 3 while having the quadriceps stimulated)
- •Willing to delay anti-spastic treatments like botulinic toxins and motor blockers until the end of the rehabilitation period included in the protocol
排除标准
- •Multiple strokes
- •Does not respond sufficiently to electrical stimulation
- •Contraindication to electrical stimulation
- •Comprehension, psychiatric or cognitive problems that could hamper the protocol
- •Bilateral stroke or subtentorial stroke
- •Able to walk without the support of one person (new functionnal ambulatory clssification equal to 4 or more)
- •Needing help from more than one person to walk (new functionnal ambulatory classification equal to 0)
- •Moderate spasticity in one or more lower body muscle groups (Modified Ashworth Scale Score >= 2)
研究组 & 干预措施
Multichannel functionnal electrical stimulation
The participants will complete 24 rehabilitation sessions over the course of 8 to 12 weeks. During each rehab session, they will receive functionnal electrical stimulation only on their paretic side, the non-paretic side will not receive functionnal electrical stimulation.
干预措施: Multichannel functionnal electrical stimulation (Device)
结局指标
主要结局
Change in walking speed at intermediate evaluation
时间窗: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test without any electrical stimulation. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V2 = Speed at V2(intermediate) - Speed at V1(baseline).
Change in walking speed at post-treatment evaluation
时间窗: At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V3 = Speed at V3(post-treatment) - Speed at V1(baseline).
Change in walking speed at follow-up evaluation
时间窗: At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V4 = Speed at V4(follow-up) - Speed at V1(baseline).
Change in walking speed at intermediate evaluation
时间窗: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test without any electrical stimulation. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V2 = Speed at V2(intermediate) - Speed at V1(baseline).
Change in walking speed at post-treatment evaluation
时间窗: At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V3 = Speed at V3(post-treatment) - Speed at V1(baseline).
Change in walking speed at follow-up evaluation
时间窗: At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)
Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V4 = Speed at V4(follow-up) - Speed at V1(baseline).
次要结局
- Change in walking endurance at intermediate evaluation(At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline))
- Change in walking endurance at post-treatment evaluation(At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline))
- Change in walking endurance at follow-up evaluation(At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline))
- Change in muscle spasticity at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in muscle spasticity at post-treatment evaluation(At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline))
- Change in muscle spasticity at follow-up evaluation(At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline))
- Change in muscle strength at intermediate evaluation(At baseline evaluation and intermediate evaluation (4 to 6 weeks after baseline))
- Change in muscle strength at post-treatment evaluation(At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline))
- Change in muscle strength at follow-up evaluation(At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline))
- Change in ambulation capacity at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in ambulation capacity at follow-up evaluation(At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline))
- Change in health perception at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in satisfaction with the treatment device at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in satisfaction with the treatment device at follow-up evaluation(At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline))
- Change in functional ambulation classification at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in functional ambulation classification at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in functional ambulation classification at follow-up evaluation(At baseline evaluation and post-treatment evaluation(16 to 20 weeks after baseline))
- Change in walking endurance at intermediate evaluation(At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline))
- Change in walking endurance at post-treatment evaluation(At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline))
- Change in walking endurance at follow-up evaluation(At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline))
- Change in muscle spasticity at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in muscle spasticity at post-treatment evaluation(At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline))
- Change in muscle spasticity at follow-up evaluation(At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline))
- Change in muscle strength at intermediate evaluation(At baseline evaluation and intermediate evaluation (4 to 6 weeks after baseline))
- Change in muscle strength at post-treatment evaluation(At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline))
- Change in muscle strength at follow-up evaluation(At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline))
- Change in ambulation capacity at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in ambulation capacity at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in ambulation capacity at follow-up evaluation(At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline))
- Change in health perception at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in health perception at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in health perception at follow-up evaluation(At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline))
- Change in satisfaction with the treatment device at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in satisfaction with the treatment device at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in satisfaction with the treatment device at follow-up evaluation(At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline))
- Change in functional ambulation classification at intermediate evaluation(At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline))
- Change in functional ambulation classification at post-treatment evaluation(At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline))
- Change in functional ambulation classification at follow-up evaluation(At baseline evaluation and post-treatment evaluation(16 to 20 weeks after baseline))