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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371290
Recruitment Status : Unknown
Verified December 2017 by Caren Luciane Bernardi, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Caren Luciane Bernardi, Federal University of Health Science of Porto Alegre

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date December 13, 2017
Actual Study Start Date  ICMJE September 27, 2017
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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 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 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 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 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • Change Manual dexterity [ Time Frame: changes from baseline at 30 minutes after each session ]
    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 [ Time Frame: changes from baseline at 30 minutes after each session ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke
Official Title  ICMJE Acute Effect of Mirror Therapy on Motor Control, Manual Dexterity and Spasticity of Paretic Upper Extremity After Chronic Stroke
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: Mirror Therapy
    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).
  • Other: Control Intervention

    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.

Study Arms  ICMJE
  • Experimental: Mirror Therapy Intervention
    Intervention: Other: Mirror Therapy
  • Active Comparator: Control Intervention
    Intervention: Other: Control Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2017
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03371290
Other Study ID Numbers  ICMJE CEP UFCSPA 90050-170
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Caren Luciane Bernardi, Federal University of Health Science of Porto Alegre
Study Sponsor  ICMJE Federal University of Health Science of Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Health Science of Porto Alegre
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP