The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.

Study Overview
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Brief Summary
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The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis.

Detailed Description
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At baseline, the Static Balance Test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The Static Balance Test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the Static Balance Test.

Official Title
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The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Static Balance Test
* Other: Berg Balance Scale
* Other: Timed Up an Go Test
* Other: Four Square Step Test
* Other: Functional Reach Test
* Other: One-leg Stance Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years, neurologist-diagnosed Multiple Sclerosis, Expanded Disability Status Scale (EDSS) score < 7, able to walk 10 m with or without aids, no MS exacerbation within the last 2 months, use of stable medication in the last 2 months, Exclusion Criteria: other neurologic disorder, Pregnancy, orhopedic problems iaffecting gait and stance, visual, auditory, orientational problems that could affect study results, Cardiovascular, pulmonary, and humoral disease.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Multiple Sclerosis<br>Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score < 7) | Other: Static Balance Test<br>* Balance control is assessed by the Static Balance Test.<br>Other: Berg Balance Scale<br>* Functional balance is assessed by the Berg Balance Scale.<br>Other: Timed Up an Go Test<br>* Functional mobility is assessed by the Timed Up and Go test.<br>Other: Four Square Step Test<br>* Dynamic balance is assessed by the Four Square Step Test.<br>Other: Functional Reach Test<br>* Limits of stability is assessed by the Functional Reach Test.<br>Other: One-leg Stance Test<br>* Postural steadiness is assessed by the One-leg Stance Test.<br>|
| Healthy Controls<br>Healthy people | Other: Static Balance Test<br>* Balance control is assessed by the Static Balance Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Balance Test | The Static Balance Test is used to assess balance control. The Static Balance Test, consists of five posture-holding tasks (sitting, stride standing, close standing, one-foot standing on the unparalyzed leg, and one-foot standing on the paralyzed leg). Four grades, 1-4, are used to judge the ability of patients to hold these postures. The grade at which a subject is rated on a task is taken as the score for that task. Hence, the minimum Static Balance Test score is 5, and the maximum is 20. A higher score indicates better balance. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance. | 15 minutes | 
| Timed Up and Go Test | Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair. A lower score indicates better functional mobility. | 1 minutes | 
| Four Square Step Test | The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square. A lower score indicates better dynamic balance. | 1 minutes | 
| One-leg Stance Test | The clinical test of One-leg Stance Test assesses postural steadiness in a static position by a quantitative measurement i.e. the number of seconds a person can maintain the One-leg Stance Test position, thus implying that better postural steadiness would allow for longer standing on one leg. | 5 minutes | 
| Functional Reach Test | The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor. A higher score indicates better limits of stability. | 30 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Static Balance Test, Balance, Reliability, Validity