Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation

Study Overview
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Brief Summary
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In this study, it was aimed to evaluate whether or not NMES in front of the mirror brings an additional benefit to mirror therapy alone or NMES alone on upper extremity motor and functional development, spasticity, anxiety, depression, cognitive function and activities of daily living, and neuropathic pain.

Detailed Description
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Cerebrovascular diseases are the general name given to clinical neurological pictures that occur as a result of pathological changes in the blood vessels of the primary lesion and / or in the properties of the blood passing through them. Many complications develop in the acute and chronic periods in patients with stroke, and the rate of complication development has been reported to vary between 40-96% in different studies. The aim of hemiplegic upper extremity rehabilitation is to prevent complications and improve lost motor-sensory control. Upper limb rehabilitation is less successful than lower limb rehabilitation because the upper limb is more functional and more complex. For muscle reeducation, NMES is used to strengthen inhibited muscle groups, facilitate voluntary isolated muscle contraction, prevent muscle atrophy, increase metabolism and enzyme activity, change the contractile properties of the muscle, maintain or increase the normal range of motion of the joint, develop voluntary movement and functional gains. NMES has been used in hemiplegia rehabilitation since 1960 for the purpose of functional retraining of muscles. The purpose of this treatment is to enable the muscles with impaired neural function of the electrical current to perform a functional and useful movement. Applications in front of the mirror are thought to trigger the neuronal connections in the motor cortex associated with the imagined movement. Findings obtained from studies with functional magnetic resonance support this theory. Compared to conventional PR, applications in front of the mirror are thought to have more and longer-lasting effects.

Official Title
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Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study

Conditions
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Hemiplegia, Upper Extremity Dysfunction

Intervention / Treatment
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* Other: Group Mirror
* Device: Group NMES
* Other: Group Mirror+NMES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacute hemiplegia Patients who can communicate well, are motivated enough and are willing to participate in the study Patients' medical conditions are stable Initiation of voluntary extension movement in the wrist (lower limit) Exclusion Criteria: The presence of more than one previous cerebrovascular disease (except transient ischemic attack). Presence of flaccid hemiplegia. Presence of a previous neurological disease causing a decrease in strength in the affected extremity. Presence of deformity due to a previous fracture, inflammatory arthropathy, etc. in the affected extremity. Presence of more than grade 3 spasticity in upper extremity according to Modified Ashworth Scale Use of cardiac pace maker Presence of fatal cardiac arrhythmia Presence of seizure history within 2 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Controlled, Single-Blinded Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Mirror<br>Along with conventional rehabilitation techniques, patients will be given ROM exercises in all directions, in front of the real mirror, by the practitioner on the healthy upper extremity for 30 minutes. | Other: Group Mirror<br>* For 30 minutes, ROM exercises will be applied to the solid upper extremity in all directions in front of a real mirror by the practitioner. (3 weeks, 5 days a week, 15 sessions in total)<br>* Other names: Mirror theraphy;|
| Active Comparator: Group NMES<br>Along with conventional rehabilitation techniques, NMES will be applied to the hemiplegic arm for 30 minutes by the practitioner while the patients are sitting in a chair. | Device: Group NMES<br>* NMES will be applied to the hemiplegic arm(deltoid, elbow extensors and forearm) for 30 minutes by the practitioner (3 weeks, 5 days a week, 15 sessions in total)<br>* Other names: NMES (neuromuscular electrical stimulation);|
| Active Comparator: Group Mirror+NMES<br>In addition to conventional rehabilitation techniques, patients will be given ROM exercises for 30 minutes in all directions in front of the real mirror to the healthy extremity, which the practitioner will synchronize with visual or auditory stimuli, and NMES treatment for 30 minutes to the paretic upper extremity. | Other: Group Mirror+NMES<br>* The practitioner will be synchronized with visual or auditory stimuli, and ROM exercises in all directions in front of the real mirror for 30 minutes, and NMES therapy for 30 minutes on the paretic upper extremity will be applied together. (3 weeks, 5 days a week, 15 sessions in total)<br>* Other names: Mirror therapy+NMES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity Motor Rating Scale | To analysis the increase in upper limb motor function | Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week | 
| Modified Tardieu Scale | For spasticity | Change from Baseline Modified Tardieu Scale at 3rd week | 
| Modified Ashworth Scale | For spasticity | Change from Baseline Modified Ashworth Scale at 3rd week | 
| Brunnstrom stages | For improvement of upper limb motor function | Change from Baseline Brunnstrom stages at 3rd week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety-Depression Scale (HADS) | For depression | Change from Baseline Hospital Anxiety-Depression Scale at 3rd week | 
| Mini-Mental Test | for cognitive functions | Change from Baseline Mini-Mental Test at 3rd week | 
| Numeric Rating Scale | for pain | Change from Baseline Numeric Rating Scale at 3rd week | 
| Pain Detect Questionnaire | for neuropathic pain | Change from Baseline Pain Detect Questionnaire at 3rd week | 
| Functional Independence Scale (FIM) | for daily life activities | Change from Baseline Functional Independence Scale (FIM) at 3rd week | 
| Ideomotor Apraxia Test | for apraxia | Change from Baseline Ideomotor Apraxia Test at 3rd week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegia, mirror theraphy, NMES