Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Fugl Meyer Assessment - Upper Limb (FMA-UE)
研究概览
简要总结
After stroke, patients frequently suffer from arm or hand weakness. There are numerous rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is particularly interesting in cases for which impairment is severe, as many other forms of therapy are often impossible.
During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb. Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving.
The objective of this study is to better determine the efficacy of MT. The investigators will therefore compare recovery of arm function in two groups of patient, that perform a regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One group performs MT and the other one performs a therapy in which the same movements are performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation to each group will be randomized. Arm function will be evaluated by use of a scale before, during and after the 4 week period. The assessor for the primary outcome measure will not know in which group the patient is. There will be a total of 30 patients included over a one year study period.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke, diagnosed clinically and by imagery, more than one month after onset;
- •Severe upper limb paresis with Upper-Extremity Fugl-Meyer Score < 19/60 .
排除标准
- •Significant limitation in upper limb function predating the recent stroke, caused by former symptomatic stroke and/or an orthopedic/rheumatologic disease;
- •Neuropsychologic or psychiatric impairment with significant interference with participation in therapy;
- •Severe visual impairment.
研究组 & 干预措施
Mirror Therapy (MT)
Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.
干预措施: Mirror Therapy (Other)
Control Therapy (CT)
Standard therapy + 30 min/day of CT.
干预措施: Control Therapy (Other)
结局指标
主要结局
Change in Fugl Meyer Assessment - Upper Limb (FMA-UE)
时间窗: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) at different time points: before, during, after intervention and after a 6 week follow-up.
次要结局
- Change in Bell cancellation task(Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.)
- Change in Numeric pain scale(Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.)
- Change in Functional Independence Measure (FIM)(Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.)
- Change in Line bisection task(Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.)
研究者
Leemann Beatrice
Medical Doctor (MD)
University Hospital, Geneva