Clinical trial NCT03371290: Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke
Official title: Acute Effect of Mirror Therapy on Motor Control, Manual Dexterity and Spasticity of Paretic Upper Extremity After Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:1) 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).

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Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change Movement Cycle Time (MCT)
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Index of Curvature (IC)
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Average Jerk (AJ)
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Mean Movement Velocity (MMV)
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Adjusting Sway (AS)
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Range of motion
timeFrame: changes from baseline at 30 minutes after each session
Secondary outcomes:
measure: Change Manual dexterity
timeFrame: changes from baseline at 30 minutes after each session
measure: Change Spasticity of paretic upper extremity
timeFrame: changes from baseline at 30 minutes after each session
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: RS
Study officials:
References: