Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke

NCT03371290 | Unknown DMC

• 1 other identifier: CEP UFCSPA 90050-170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• Change Movement Cycle Time (MCT)

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

  changes from baseline at 30 minutes after each session

• Change Index of Curvature (IC)

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

  changes from baseline at 30 minutes after each session

• Change Average Jerk (AJ)

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

  changes from baseline at 30 minutes after each session

• Change Mean Movement Velocity (MMV)

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

  changes from baseline at 30 minutes after each session

• Change Adjusting Sway (AS)

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

  changes from baseline at 30 minutes after each session

• Change Range of motion

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

  changes from baseline at 30 minutes after each session

Secondary Outcomes (2)

• Change Manual dexterity

  changes from baseline at 30 minutes after each session

• Change Spasticity of paretic upper extremity

  changes from baseline at 30 minutes after each session

Study Arms (2)

Mirror Therapy Intervention

EXPERIMENTAL

Other: Mirror Therapy

Control Intervention

ACTIVE COMPARATOR

Other: Control Intervention

Interventions

Mirror Therapy OTHER

The healthy UE will be positioned in front of the mirror and the paretic UE behind it, enabling the patient to observe the movements of the healthy limb through the mirror, interpreting that image as the affected limb. The MT protocol will be composed of active bimanual exercises of range of motion and functional exercises. Three sets of 15 repetitions will be performed for each exercise with a 20 seconds interval between each series, for 30 minutes. The exercises: 1) Elbow flexion/extension; 2) Wrist flexion/extension in neutral position; 3) Fingers flexion/extension in neutral position; 4) Forearm pronation/supination; 5) Roll the ball with hands; 6) Squeezing the sponge; 7) Drag a towel in anteroposterior direction; 8) Opponency of fingers; 9) Climb the mirror with the fingers (similar to walking the spider).

Mirror Therapy Intervention

Control Intervention OTHER

In the control intervention, patients will be performed the same bimanual activities proposed by the MT protocol, but without the reflector side of the mirror. The mirror will be placed in the same position as the MT intervention. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. Both interventions will be performed a single session of MT or control composed of 30 minutes of exercises. The participants who will be first assigned to the MT intervention, after 4-weeks washout period, will be performed the same procedures, but in the control intervention. Likewise, patients who will be first allocated to control intervention, after 4-weeks of washout, will be performed the same procedures, however in MT intervention.

Control Intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 13, 2017
• Study Start: September 27, 2017
• Primary Completion: September 28, 2017
• Study Completion: December 30, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

BR (1)