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Clinical Trials/NCT03371290
NCT03371290
Unknown
N/A

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 Alegre1 site in 1 country40 target enrollmentSeptember 27, 2017
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
40
Locations
1
Primary Endpoint
Change Average Jerk (AJ)
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 27, 2017
End Date
December 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Caren Luciane Bernardi

Doctor

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • 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).

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.

Outcomes

Primary Outcomes

Change Average Jerk (AJ)

Time Frame: changes from baseline at 30 minutes after each session

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

Change Adjusting Sway (AS)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: changes from baseline at 30 minutes after each session

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

Secondary Outcomes

  • 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)

Study Sites (1)

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