Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors

Study Overview
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Brief Summary
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The aim of the biomedical research is to evaluate the changes of body position management during standing and walking for stroke patients, using innovative training methods during the rehabilitation.

Official Title
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Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position During Standing and Walking for Patients With Stroke During the Second Stage of Rehabilitation

Conditions
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Brain Ischemia, Stroke, Ischemic

Intervention / Treatment
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* Other: Standard physiotherapy
* Device: Biodex Balance SD and Biodex Gait Trainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experienced an ischemic stroke for the first time; Middle-aged (44-59) and elderly (60-74) by WHO classification; Muscle strength of the lower extremities according to the Oxford scale is 3-5 points; Do not have any neglect; Mini Mental State Examination >12 points. Exclusion Criteria: Experienced an ischemic stroke not for the first time; Had hip or knee replacement surgery's, which may affect gait; Muscle strength of the lower extremities according to the Oxford scale is 0-2 points; Have neglect; Mini Mental State Examination <12 points.

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 74 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: Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Group<br>Neuromuscular exercise program with standard physiotherapy with no visual feedback. | Other: Standard physiotherapy<br>* Neuromuscular exercise program with standard physiotherapy with no visual feedback<br>|
| Experimental: Second Group<br>Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform | Device: Biodex Balance SD and Biodex Gait Trainer<br>* Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength by Oxford scale | Testing key muscles from the lower and upper extremities against the examiner's resistance and grading the patient's strength on a 0 (No contraction) to 5 (Movement against gravity with full resistance) scale. | Baseline | 
| Gait and Balance testing by Berg Scale | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk). | Baseline | 
| Timed Stand Up and Go Test | subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. 314. The test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time. | Baseline | 
| Recovery Locus of Control Scale | This scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limits of Stability Testing with Biodex SD (score) | During test, patients must shift their weight to move the cursor from the center target to a colored target and back as quickly and with as little deviation as possible. Platform Setting- static. Direction control - overall. Faster and accurately- better. | Baseline - before enrolling 4 week training program and after 4 week training | 
| Risk of Fall Testing with Biodex SD (score) | Test results are compared to age dependent normative data. Platform Setting - static. Test Trial Time 30 seconds in four positions: eyes opened narrow stance, eyes closed narrow stance, eyes opened closed feet stance, eyes closed stance. Patient's aged 54-71 years' normative scores are 0.9-3.7 scores, 72-89 years' normative scores are 2-4 scores, 36-53 years' normative scores are 0.7-3.1 scores, 17-35 years' normative scores are 0.7-2.1 scores. Change from baseline indicates a fall risk by scores. | Baseline - before enrolling 4 week training program and after the whole training | 
| Stance analysis with zebris FDM (score) | Stance phase analysis (stance parameters and forces) - average load distribution under the feet is displayed in color. The color scale enables the load distribution to be quantified. The central point's show the centers of pressure (COP) over the time. The left and right points are the respective centers of pressure of the left and right contact areas. The area of the displayed confidence ellipse contains 95% of the COP's measuring points. | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait geometry: Foot rotation(degree) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait geometry: Step length(cm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait geometry:Stride length(cm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait geometry: Step width(cm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Stance phase(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Load response(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Single limb support(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Pre-Swing(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Swing phase(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait phases: Double stance phase(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait timing: Step time(sec) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait timing: Stride time(sec) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait timing: Cadence(steps/min) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Gait analysis with zebris FDM (score) | Analysis of gait timing: Velocity(km/h) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Butterfly parameters): Length of gait line(mm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Butterfly parameters): Single limb support line(mm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Butterfly parameters): Anterior/posterior position(mm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Butterfly parameters): Lateral symmetry(mm) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Butterfly parameters): Max gait line velocity(cm/sec) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Load change parameters): Time change heel to forefoot(sec) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Load change parameters): Time change heel to forefoot(%) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Load change parameters): Maximum force (Forefoot, Midfoot, Heel) (N) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Load change parameters): Maximum pressure (Forefoot, Midfoot, Heel) (N/cm²) | Baseline - before enrolling 4 week training program and after 4 week training | 
| Center of Pressure analysis during step cycles with zebris FDM (score) | COP analysis (Load change parameters): Time maximum force (Forefoot, Midfoot, Heel)(% of stance) | Baseline - before enrolling 4 week training program and after 4 week training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Ischemia, Stroke, Balance, Gait, Physiotherapy, Physical Therapy, Visual Feedback