Effect of Mirror Therapy in Sensorimotor Recovery of The Paretic Upper Extremity After Chronic Stroke: a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Sensory function of the paretic upper extremity
研究概览
简要总结
Stroke is characterized by poor brain perfusion resulting from an ischemic or hemorrhagic event, causing a sensorimotor disorder in the upper extremity (UE) contralateral to the lesion. Mirror Therapy (MT) has been used in rehabilitation and its effects are related to the activation of mirror neurons and cortical reorganization. However, few studies have investigated the isolated effect of MT on the rehabilitation of these individuals.
Objective: To investigate the isolated effect of MT on motor function, sensitivity, muscle strength, manual dexterity and spasticity of the paretic UE of individuals with chronic hemiparesis after stroke.
Design: Randomized simple-blind trial. Subject: Twenty-six patients post chronic, aged between 30 and 80 years, with mild or moderate sensorimotor impairment in UE will be evaluated.
Intervention: The subjects will be randomly distributed in: intervention group will perform 60 minutes of MT and the control group will perform 60 minutes of control therapy composed of the same exercises, but without the mirror. Both groups will hold two sessions per week for six weeks.
Main measure: Participants will be evaluated before and after the intervention. They will be evaluated through the Fugl-Meyer Scale to measure UL sensorimotor performance, Box-and-Block Test for manual dexterity, Dynamometry for palmar grip strength and Modified Ashworth Scale for spasticity. With this study, it was expected that the intervention group presented better results regarding the sensorimotor function when compared to the control group.
The data will be expressed as mean and 95% confidence interval (continuous variable) and absolute frequency (categorical variables). To compare the outcomes of the different experimental sessions and at the different moments (pre and post session), the Generalized Estimating Equations with post hoc LSD (Least Significant Difference) methods will be used. For all analysis the significance level was set at α = 0.05 and statistical software SPSS (Statistical Package for Social Sciences for Mac, version 22.0, IBM, USA) will be used.
详细描述
Sample Size: The sampling was simple random and the calculation of the sample size needed to carry out this research was estimated using GPower software. The power and standard deviation were estimated from previous studies (Park et al., 2015) with a similar design. The sample size estimate for the present research project was 13 individuals per group (Mirror Therapy group and control group), totalizing 26 individuals, considering a level of significance (p) 5% and power of 80%.
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
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have suffered a single stroke, ischemic or hemorrhagic at least 6 months prior to the study and at most 5 years prior to the study, diagnosed by MRI and / or CT scan;
- •Age between 30 and 80 years;
- •Spasticity ≤ 3 in the flexor muscles of the elbow, wrist and fingers, shoulder horizontal adductor (Ashworth Modified Scale);
- •Mild or moderate sensorimotor impairment (Fugl-Meyer score scale - mild: 58-64 points, moderate: 39-57 points);
- •Present ability to understand the instructions of the study (Mini-Mental score ≥ 18 for schooled individuals and ≥ 13 for illiterate individuals);
- •Present muscular strength ≥ 3 in the flexor muscles of shoulder, and extensors of elbow and wrist.
- •Be able to stay in position for more than 30 minutes;
排除标准
- •Visual deficit that may limit participation in Mirror Therapy;
- •History of severe depression or severe psychiatric disorder;
- •Other neurological or musculoskeletal disorders in the upper limb not related to the stroke;
- •Severe visuospatial negligence.
研究组 & 干预措施
Intervention group
All patients will perform 60 minutes of intervention, twice a week, for six weeks. During the intervention, the patient will be positioned seated in a chair with a table in front of him and a mirror (50cm x 50cm) will be placed vertically between his upper extremity.
The patient's paretic upper extremity will be positioned behind the mirror, allowing only the movements of his healthy upper extremity to be visualized. The reflective side of the mirror will be facing the healthy upper extremity , the patient will perform the exercises observing the movements of his healthy upper extremity through the reflection produced by the mirror, interpreting as the movement of his paretic member.
干预措施: Mirror therapy intervention and control intervention (Other)
Control group
All patients will perform 60 minutes of intervention, twice a week, for six weeks. The mirror will be placed in the same position as the intervention group. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. In the control group, the patients will be submitted to the same bimanual activities of the intervention group, but without the reflecting side of the mirror. Thus, the nonreflective side of the mirror will be facing the healthy arm, the patient will perform the same exercises visualizing only the movement of the healthy member.
干预措施: Mirror therapy intervention and control intervention (Other)
结局指标
主要结局
Sensory function of the paretic upper extremity
时间窗: 15 minutes
The Fugl-Meyer Sensory Rating Scale - FMAS - upper extremity section will be applied to measure the sensory function of the paretic limb. Sensation is assessed as absent, deficient or normal for light touch and proprioception. This evaluation considered the shoulder, elbow, wrist and thumb. Each item has three possible scores: 0 (anesthesia); 1 (hypoesthesia or anesthesia) and 2 (normal). A total score ranged from 0 to 12 points, a higher score indicate a better sensory function.
Motor function of the paretic upper extremity
时间窗: 20 minutes
The Fugl-Meyer motor assessment scale - FMAS - upper extremity section will be applied to measure the motor function of the paretic limb. In the motor domain, the tendon reflexes, synergistic movements, coordination and velocity of the upper limb are evaluated. It also includes evaluation of wrist movements and five types of grip. It consists of a cumulative numerical scoring system that evaluates the motor function of the upper extremity. Each item has three possible scores: 0 (not performed); 1 (partially accomplished) and 2 (fully realized). The total score ranged from 0 to 66 points, with scores ranging from 58-64 reflect mild impairment, 39-57 moderate impairment, and values below 39 show severe impairment.
次要结局
- Pain of paretic upper extremity(2 minutes)
- Palmar grip strength(10 minutes)
- Level of functional disability(15 minutes)
- Manual dexterity(10 minutes)
- Quality of life after stroke: The Stroke Impact Scale 3.0(15 minutes)
- Spasticity of paretic upper extremity(10 minutes)
研究者
Caren Luciane Bernardi
Principal Investigator
Federal University of Health Science of Porto Alegre