跳至主要内容
临床试验/NCT03371290
NCT03371290Unknown不适用

Acute Effect of Mirror Therapy on Motor Control, Manual Dexterity and Spasticity of Paretic Upper Extremity After Chronic Stroke

Federal University of Health Science of Porto Alegre2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change Average Jerk (AJ)

研究概览

简要总结

Objective: To investigate the acute effect of mirror therapy (MT) on motor control, manual dexterity and spasticity of the paretic upper extremity (UE) of individuals with chronic hemiparesis after stroke, during reaching task.

Design: Randomized cross-over single-blinded trial. Subjects: Thirty-three patients post chronic stroke were recruited of the study.

Intervention: Patients who first participated in the MT intervention performed a single session of MT, whereas in the control intervention a single session composed of the same exercises was performed, but without the mirror. After a month washout, the patients switched groups.

Main measure: The primary outcome measure was motor control. The secondary outcome measure was manual dexterity and UE spasticity.

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.

Key words: Stroke, mirror therapy, upper extremity, kinematic analysis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, 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

入选标准

  • to have a diagnosis of unilateral, ischemic or hemorrhagic, stroke for at least 6 months and at most 5 years ; 2) age between 30 and 80 years; 3) cognitive ability to follow the instructions of the study (Mini-Mental score ≥ 18 for schooling and ≥ 13 for illiterate);4) mild or moderate motor sensory impairment (Fugl-Meyer Assessment Scale - mild: 58-64 points, moderate: 39-57 points); 5) spasticity ≤ 2 in the flexor elbow and wrist muscles, and horizontal shoulder adductor (Modified Ashworth Scale); 6) muscle strength ≥ 3 in the flexor muscles of the shoulder, elbow and wrist, and elbow and wrist extensors (Kendall assessement).

排除标准

  • Patients with visual impairment; history of severe depression or severe psychiatric disorder; other neurological or musculoskeletal disorders in the UE; visuospatial heminegligence; or pain file ≥ 4 on the compromised UE (Visual Analog Pain Scale), were excluded from the study.

研究组 & 干预措施

Mirror Therapy Intervention

Experimental

干预措施: Mirror Therapy (Other)

Control Intervention

Active Comparator

干预措施: Control Intervention (Other)

结局指标

主要结局

Change Average Jerk (AJ)

时间窗: changes from baseline at 30 minutes after each session

measure of the movement smoothness, this index decreases with increased smoothness

Change Adjusting Sway (AS)

时间窗: changes from baseline at 30 minutes after each session

measure of the adjustments made to reach the target, decreases as the movement precision increases

Change Movement Cycle Time (MCT)

时间窗: changes from baseline at 30 minutes after each session

The time to perform the cycle of movement in seconds, which includes the going and return phase of the arm to the table

Change Index of Curvature (IC)

时间窗: changes from baseline at 30 minutes after each session

representative of the movement straightness during the going phase, an IC equal to 1 indicates a perfectly rectilinear motion

Change Mean Movement Velocity (MMV)

时间窗: changes from baseline at 30 minutes after each session

fingernail marker mean velocity during the going phase, an increased MMV indicates an improves task performance

Change Range of motion

时间窗: changes from baseline at 30 minutes after each session

Range of motion of shoulder (flexion/extension, abduction/adduction) and elbow (flexion/extension).

次要结局

  • Change Spasticity of paretic upper extremity(changes from baseline at 30 minutes after each session)
  • Change Manual dexterity(changes from baseline at 30 minutes after each session)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caren Luciane Bernardi

Doctor

Federal University of Health Science of Porto Alegre

研究点 (2)

Loading locations...

相似试验

Acute Effect of Mirror Therapy on Rehabilitation of... | 临床试验