Effectiveness of Mirror Therapy in Upper Limb Rehabilitation Early After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Fugl-Meyer (upper limb section)
研究概览
简要总结
This study evaluates the effects of mirror therapy on upper-limb motor impairment in stroke patients early after their cerebrovascular accident. In recent years mirror therapy has been used in stroke rehabilitation, both to ease motor (e.g., upper limb impairment) and cognitive (e.g., spatial neglect) recovery. To note, mirror therapy is a simple and inexpensive treatment that patients can practice independently and with no significant side effects. However, a recent review concluded that the currently evidence available is not enough to determine about the actual effectiveness of mirror therapy in stroke survivors. Moreover, at our knowledge, the majority of studies recruited chronic stroke patients while only a few trials recruited patients within few weeks after stroke. Therefore, further research is encouraged particularly early after stroke.
In mirror therapy patients exercise their sound hand while it is reflected by a mirror placed at right angle to the patient's trunk. With this gambit, patients see two hands moving: their sound hand (i.e., the hand that is voluntarily moved) and the "avatar" of their impaired hand (i.e., the sound hand reflection in the mirror). In this assessor-blinded, randomized controlled trial half of participants receive mirror therapy .The other half receive sham therapy, in which the mirror is flipped so that the opaque surface face the sound arm. Mirror therapy and sham therapy are added to conventional rehabilitation.
In the current work, we investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients.
详细描述
An assessor blind, randomized controlled study was conducted in the Casa di Cura Del Policlinico (CCP), an inpatient rehabilitation clinic in Milan. Stroke patients were referred to the study by their physician during their inpatient stay.
In addition to the intervention or control treatment, all patients participated to a conventional rehabilitation program consisting of physiotherapy (45 minutes per session, twice daily, five days per week) and occupational therapy (45 minutes per session, once a day, two to five days per week according to the physician prescription). Speech and language therapy and neuropsychological therapy were provided as needed. All treatments were one on one sessions.
Patients were measured at baseline and after five weeks, when treatments end. The assessors were blinded to group allocation.
Eligible patients were randomly assigned to either the intervention group or the control group. We used block randomization so that the number of participants was similar in the two groups (four patients per block, 1:1 ratio). A computer generated the randomization list and when a new eligible patient was recruited, a researcher contacts the person that allocate patient in mirror therapy or sham therapy group according to the randomization list. Patients were unaware of the group assignments (intervention vs. control) and of the alleged active treatment. All patients gave their informed written consent to participate in the study.
Patients of the intervention group received mirror therapy and patients of the control group received sham therapy, added to a conventional rehabilitation program. During mirror therapy, the patient was sitting on a conventional chair and placed her/his forearms on a table. A mirror (45 cm × 40 cm) was positioned between the two arms, at right angle with the patient's trunk. The reflective surface was oriented so that the participant could easily see the mirror image of his/her sound arm. During sham therapy, the mirror was flipped so that the opaque surface faced the sound arm.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ischemic or hemorrhagic stroke causing right or left hemiplegia or hemiparesis;
- •enrolling in the trial within four weeks from the stroke;
- •Mini Mental State Examination (MMSE) score ≥ 24, in order to exclude patients with significant cognitive decline;
- •Token Test score < 40, in order to exclude patients with severe verbal comprehension deficits.
排除标准
- •significant visual impairment despite glasses,
- •cognitive deficits that could prevent patients from understanding the therapist instructions,
- •an additional neurological or orthopedic disease (e.g., Parkinson's disease, limb amputation) known to cause a motor impairment for itself.
研究组 & 干预措施
Mirror therapy
Patient is sitting on a conventional chair and placed her/his forearms on a table. A mirror (45 cm × 40 cm) is positioned between the two arms, at right angle with the patient's trunk. The reflective surface is oriented so that the participant could easily see the mirror image of his/her sound arm. Patient practises his/her sound arm with exercises, ranging from the simple elbow flexion-extension to complex tasks.
干预措施: Mirror therapy (Other)
Sham therapy
Patient is sitting on a conventional chair and placed her/his forearms on a table. A box (45 cm × 40 cm) is positioned between the two arms, at right angle with the patient's trunk. The opaque surface replaces the mirror reflecting surface. Patient practises his/her sound arm with exercises,ranging from the simple elbow flexion-extension to complex tasks.
干预措施: Mirror therapy (Other)
结局指标
主要结局
Fugl-Meyer (upper limb section)
时间窗: Change from baseline FMA at six week.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia.
次要结局
- Functional Independence Measure(Change from baseline FIM at six week.)
- Action Research Arm Test(Change from baseline ARAT at six week.)