Mirror Therapy in Sensorimotor Recovery of Paretic Upper Extremity After Chronic Stroke

NCT ID: NCT04030806

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2019-12-31

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.

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%.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mirror therapy intervention and control intervention

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Mirror therapy intervention and control intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Have suffered a single stroke, ischemic or hemorrhagic at least 6 months prior to the study and at most 5 years prior to the study, diagnosed by MRI and / or CT scan;

2. Age between 30 and 80 years;

3. Spasticity ≤ 3 in the flexor muscles of the elbow, wrist and fingers, shoulder horizontal adductor (Ashworth Modified Scale);

4. Mild or moderate sensorimotor impairment (Fugl-Meyer score scale - mild: 58-64 points, moderate: 39-57 points);

5. Present ability to understand the instructions of the study (Mini-Mental score ≥ 18 for schooled individuals and ≥ 13 for illiterate individuals);

6. Present muscular strength ≥ 3 in the flexor muscles of shoulder, and extensors of elbow and wrist.

7. Be able to stay in position for more than 30 minutes;

Exclusion Criteria

1. Visual deficit that may limit participation in Mirror Therapy;

2. History of severe depression or severe psychiatric disorder;

3. Other neurological or musculoskeletal disorders in the upper limb not related to the stroke;

4. Severe visuospatial negligence.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Caren Luciane Bernardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Caren Luciane Bernardi

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

CBernardi

Identifier Type: -

Identifier Source: org_study_id