Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. In addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. The stabilizing muscles, defined as the core region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. The aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with Multiple Sclerosis.

Official Title
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Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait

Conditions
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Multiple Sclerosis, Gait Disorders, Neurologic

Intervention / Treatment
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* Other: Physiotherapy - Study group
* Other: Physiotherapy - control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old EDSS score is between 3-5,5 Patients who did not take corticosteroid therapy within three months Patients who get at least 24 points from the Mini Mental Test were included in the study. Exclusion Criteria: Patients who had an acute MS attack or had an attack within the last three months. An orthopedic or systemic problem that would prevent participation in exercises Patients who were using walking orthoses or walking aids were not included in the study.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Spinal stabilization exercises in addition to home exercise program | Other: Physiotherapy - Study group<br>* Study group : In addition to home program spinal stabilization exercises<br>|
| Active Comparator: Control Group<br>Home exercise program | Other: Physiotherapy - control group<br>* Home exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walk Test | Maximum Walking Distance in 6 Minutes | Change from Baseline 6 Minutes Walking Distance at 6 weeks. | 
| Modified Borg Scale | Evaluating fatigue between the scores of 0 and 10. 0 means no fatigue at all. 10 means maximal fatigue. | Change from Baseline Fatigue Score at 6 weeks. | 
| Plantar Pressure Distribution | Peak pressure values of 10 subregions under the foot | Change from baseline peak pressure and contact area values at 6 weeks | 
| Plantar Pressure Distribution | Contact area values of 10 subregions under the foot | Change from baseline peak pressure and contact area values at 6 weeks | 
| Multiple Sclerosis Quality of Life Scale | Quality of life assessment with 54 questions about mental and physical health in daily life activities. | Change from baseline mental and physical quality of life scores at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength with hand held dynamometer | Hip Flexors Muscle Strength | Change from baseline muscle strength at 6 weeks | 
| Muscle strength with hand held dynamometer | Hip Abductors Muscle Strength | Change from baseline muscle strength at 6 weeks | 
| Muscle strength with hand held dynamometer | Knee Flexors Muscle Strength | Change from baseline muscle strength at 6 weeks | 
| Muscle strength with hand held dynamometer | Knee Extensors Muscle Strength | Change from baseline muscle strength at 6 weeks | 
| Muscle strength with hand held dynamometer | Ankle Dorsiflexors Muscle Strength | Change from baseline muscle strength at 6 weeks | 
| MiniBESTest | Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status. | Change from baseline MiniBESTest scores at 6 weeks | 
| Dynamic Gait Index | Dynamic balance evaluation especially walking balance. This test includes 8 items and maximum score is 24. Maximum score means best dynamic balance status. | Change from baseline Dynamic Gait Index scores at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Gait, Spinal Stabilization Exercises, Plantar Pressure Distribution, Rehabilitation