Stroke is characterized by poor brain perfusion resulting from an ischemic or hemorrhagic event, causing a sensorimotor disorder in the upper extremity (UE) contralateral to the lesion. Mirror Therapy (MT) has been used in rehabilitation and its effects are related to the activation of mirror neurons and cortical reorganization. However, few studies have investigated the isolated effect of MT on the rehabilitation of these individuals.
Objective: To investigate the isolated effect of MT on motor function, sensitivity, muscle strength, manual dexterity and spasticity of the paretic UE of individuals with chronic hemiparesis after stroke.
Design: Randomized simple-blind trial. Subject: Twenty-six patients post chronic, aged between 30 and 80 years, with mild or moderate sensorimotor impairment in UE will be evaluated.
Intervention: The subjects will be randomly distributed in: intervention group will perform 60 minutes of MT and the control group will perform 60 minutes of control therapy composed of the same exercises, but without the mirror. Both groups will hold two sessions per week for six weeks.
Main measure: Participants will be evaluated before and after the intervention. They will be evaluated through the Fugl-Meyer Scale to measure UL sensorimotor performance, Box-and-Block Test for manual dexterity, Dynamometry for palmar grip strength and Modified Ashworth Scale for spasticity. With this study, it was expected that the intervention group presented better results regarding the sensorimotor function when compared to the control group.
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.
Condition or disease | Intervention/treatment | Phase |
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Stroke | Other: Mirror therapy intervention and control intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Mirror Therapy in Sensorimotor Recovery of The Paretic Upper Extremity After Chronic Stroke: a Randomized Clinical Study |
Actual Study Start Date : | July 3, 2019 |
Estimated Primary Completion Date : | November 30, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Experimental: Intervention group
All patients will perform 60 minutes of intervention, twice a week, for six weeks. During the intervention, the patient will be positioned seated in a chair with a table in front of him and a mirror (50cm x 50cm) will be placed vertically between his upper extremity. The patient's paretic upper extremity will be positioned behind the mirror, allowing only the movements of his healthy upper extremity to be visualized. The reflective side of the mirror will be facing the healthy upper extremity , the patient will perform the exercises observing the movements of his healthy upper extremity through the reflection produced by the mirror, interpreting as the movement of his paretic member. |
Other: Mirror therapy intervention and control intervention
The exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group). Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation. |
Sham Comparator: Control group
All patients will perform 60 minutes of intervention, twice a week, for six weeks. The mirror will be placed in the same position as the intervention group. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm. In the control group, the patients will be submitted to the same bimanual activities of the intervention group, but without the reflecting side of the mirror. Thus, the nonreflective side of the mirror will be facing the healthy arm, the patient will perform the same exercises visualizing only the movement of the healthy member.
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Other: Mirror therapy intervention and control intervention
The exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group). Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation. |
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Caren Luciane Bernardi | |
Porto Alegre, RS, Brazil, 90620-160 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 2, 2019 | ||||
First Posted Date ICMJE | July 24, 2019 | ||||
Last Update Posted Date | July 25, 2019 | ||||
Actual Study Start Date ICMJE | July 3, 2019 | ||||
Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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 | Mirror Therapy in Sensorimotor Recovery of Paretic Upper Extremity After Chronic Stroke | ||||
Official Title ICMJE | Effect of Mirror Therapy in Sensorimotor Recovery of The Paretic Upper Extremity After Chronic Stroke: a Randomized Clinical Study | ||||
Brief Summary |
Stroke is characterized by poor brain perfusion resulting from an ischemic or hemorrhagic event, causing a sensorimotor disorder in the upper extremity (UE) contralateral to the lesion. Mirror Therapy (MT) has been used in rehabilitation and its effects are related to the activation of mirror neurons and cortical reorganization. However, few studies have investigated the isolated effect of MT on the rehabilitation of these individuals. Objective: To investigate the isolated effect of MT on motor function, sensitivity, muscle strength, manual dexterity and spasticity of the paretic UE of individuals with chronic hemiparesis after stroke. Design: Randomized simple-blind trial. Subject: Twenty-six patients post chronic, aged between 30 and 80 years, with mild or moderate sensorimotor impairment in UE will be evaluated. Intervention: The subjects will be randomly distributed in: intervention group will perform 60 minutes of MT and the control group will perform 60 minutes of control therapy composed of the same exercises, but without the mirror. Both groups will hold two sessions per week for six weeks. Main measure: Participants will be evaluated before and after the intervention. They will be evaluated through the Fugl-Meyer Scale to measure UL sensorimotor performance, Box-and-Block Test for manual dexterity, Dynamometry for palmar grip strength and Modified Ashworth Scale for spasticity. With this study, it was expected that the intervention group presented better results regarding the sensorimotor function when compared to the control group. 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. |
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Detailed Description | Sample Size: The sampling was simple random and the calculation of the sample size needed to carry out this research was estimated using GPower software. The power and standard deviation were estimated from previous studies (Park et al., 2015) with a similar design. The sample size estimate for the present research project was 13 individuals per group (Mirror Therapy group and control group), totalizing 26 individuals, considering a level of significance (p) 5% and power of 80%. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Stroke | ||||
Intervention ICMJE | Other: Mirror therapy intervention and control intervention
The exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group). Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation. |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE |
26 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT04030806 | ||||
Other Study ID Numbers ICMJE | CBernardi | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |