Mirror Therapy and Cross-Education of Muscle Strength

Study Overview
=================
Brief Summary
-----------------
This study was conducted to determine whether mirror therapy has an additive effect on cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic patients was measured.

Detailed Description
-----------------
A total of 29 patients, 7 women, and 22 men were included according to the inclusion and exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES, mirror therapy was applied to the experimental group simultaneously with NMES. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

Official Title
-----------------
Additive Effect of Mirror Therapy on Effects of Cross-Education of Muscle Strength of Neuromuscular Electrical Stimulation In Hemiplegic Patients

Conditions
-----------------
Cerebrovascular Stroke, Muscle Weakness

Intervention / Treatment
-----------------
* Device: Mirror frame
* Device: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with stroke duration ≥ 1 month Ability to walk at least 10m (functional ambulation scale ≥3) Age range 18-75 years Hemorrhagic or ischemic stroke Brunnstrom stage ≥4 for lower limb Unilateral stroke Cooperating with the examination and tests Exclusion Criteria: Mini Mental State Assessment score <21 Severe spasticity (MAS = 4) in ankle dorsiflexors Have a contracture on ankle joint The presence of skin lesions in the application area Painful pathologies in the lower extremities Having visual field defects Active inflammatory, rheumatological or infectious disease Parent rhythm / conduction block problem in the heart Uncontrollable hypertension (Maxima> 140, Minima> 90) Presence of lower extremity fracture Peripheral nerve lesions such as polyneuropathy, radiculopathy Finding or suspected active deep vein thrombosis History of deep vein thrombosis and pulmonary embolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirror Therapy<br>Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors. In addition to this application, mirror therapy was applied simultaneously with NMES. | Device: Mirror frame<br>* Combined Mirror and NMES therapy<br>|
| Placebo Comparator: Control<br>Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors. | Device: Control<br>* Only NMES therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ankle dorsiflexor isometric muscle strength | Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force | Change from Baseline muscle strength at 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lower Extremity Brunnstrom score | It evaluates the developmental stages of synergy patterns, muscle tone and isolated movements of the patients in the lower extremities. Patients are categorized between Stage-1 and 6. Stage 1: Flaccidity; Stage 6: Spasticity Disappears and Coordination Reappears | Change from Baseline Brunnstrom score at 6 days | 
| Change of Modified Ashworth Scale score | Modified Ashworth Scale was used for assessment spasticity. Modified Ashworth Scale scores are varied between 0 and 4: 0 points, no increase in muscle tone; 4 points indicate spasticity with a degree of rigidity. | Change from Baseline Modified Ashworth Scale score at 6 days | 
| Change of Functional Ambulation Scale score | The Functional Ambulation Classification (FAC) is a method for classifying mobility. The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). | Change from Baseline Functional Ambulation Scale score at 6 days | 
| Change of Timed Up and Go Test score | It is a test that evaluates the patient's static and dynamic balance, mobility and walking ability. The test's score is the time in seconds it takes the subject takes to complete the test. | Change from Baseline Timed Up and Go Test score at 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cross-education, Neuromuscular electrical stimulation, Mirror Therapy