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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mirror Therapy
Control Intervention
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

-

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.

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirror Therapy Intervention

Control Intervention

Arm Description

Outcomes

Primary Outcome Measures

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
Change Index of Curvature (IC)
representative of the movement straightness during the going phase, an IC equal to 1 indicates a perfectly rectilinear motion
Change Average Jerk (AJ)
measure of the movement smoothness, this index decreases with increased smoothness
Change Mean Movement Velocity (MMV)
fingernail marker mean velocity during the going phase, an increased MMV indicates an improves task performance
Change Adjusting Sway (AS)
measure of the adjustments made to reach the target, decreases as the movement precision increases
Change Range of motion
Range of motion of shoulder (flexion/extension, abduction/adduction) and elbow (flexion/extension).

Secondary Outcome Measures

Change Manual dexterity
Box and Block Test (BBT) was used to assess the gross manual dexterity. The test consists in moving, one by one, the largest possible number of blocks from one box compartment to the other, first with the uncommitted UE and then with the paretic UE. The recorded score is equivalent to the number of blocks moved from one side of the box to the other in 60 seconds
Change Spasticity of paretic upper extremity
The Modified Ashworth Scale (MAS) was used to assess spasticity, evaluating the resistance to passive movement. The patients stayed in a sitting position to the assessment of the muscle tone of the elbow flexors, wrist flexors and horizontal shoulder adductor of the paretic UE, with three mobilizations for each muscle group. Higher scores correspond to spasticity or increase in tone, while lower scores indicate normal muscle tone.

Full Information

First Posted
November 27, 2017
Last Updated
December 11, 2017
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03371290
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy Intervention
Arm Type
Experimental
Arm Title
Control Intervention
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Movement Cycle Time (MCT)
Description
The time to perform the cycle of movement in seconds, which includes the going and return phase of the arm to the table
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Index of Curvature (IC)
Description
representative of the movement straightness during the going phase, an IC equal to 1 indicates a perfectly rectilinear motion
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Average Jerk (AJ)
Description
measure of the movement smoothness, this index decreases with increased smoothness
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Mean Movement Velocity (MMV)
Description
fingernail marker mean velocity during the going phase, an increased MMV indicates an improves task performance
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Adjusting Sway (AS)
Description
measure of the adjustments made to reach the target, decreases as the movement precision increases
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Range of motion
Description
Range of motion of shoulder (flexion/extension, abduction/adduction) and elbow (flexion/extension).
Time Frame
changes from baseline at 30 minutes after each session
Secondary Outcome Measure Information:
Title
Change Manual dexterity
Description
Box and Block Test (BBT) was used to assess the gross manual dexterity. The test consists in moving, one by one, the largest possible number of blocks from one box compartment to the other, first with the uncommitted UE and then with the paretic UE. The recorded score is equivalent to the number of blocks moved from one side of the box to the other in 60 seconds
Time Frame
changes from baseline at 30 minutes after each session
Title
Change Spasticity of paretic upper extremity
Description
The Modified Ashworth Scale (MAS) was used to assess spasticity, evaluating the resistance to passive movement. The patients stayed in a sitting position to the assessment of the muscle tone of the elbow flexors, wrist flexors and horizontal shoulder adductor of the paretic UE, with three mobilizations for each muscle group. Higher scores correspond to spasticity or increase in tone, while lower scores indicate normal muscle tone.
Time Frame
changes from baseline at 30 minutes after each session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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). - 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.
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

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

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