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

F

Federal University of Health Science of Porto Alegre

Status

Unknown

Conditions

Stroke

Treatments

Other: Mirror therapy intervention and control intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04030806
CBernardi

Details and patient eligibility

About

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.

Full 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%.

Enrollment

26 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Intervention group
Experimental group
Description:
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.
Treatment:
Other: Mirror therapy intervention and control intervention
Control group
Sham Comparator group
Description:
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.
Treatment:
Other: Mirror therapy intervention and control intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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