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

• Conditions: Multiple Sclerosis
• Interventions: 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

• Registration Number: NCT03584672
• Lead Sponsor: Gazi University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-30
• Study First Submitted QC: 2018-06-30
• Status Verified: 2018-07
• Study First Posted: 2018-07-12
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17
• Study Start: 2018-08-05
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Multiple Sclerosis	Berg Balance Scale	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Patients with Multiple Sclerosis	One-leg Stance Test	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Patients with Multiple Sclerosis	Timed Up an Go Test	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Patients with Multiple Sclerosis	Static Balance Test	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Patients with Multiple Sclerosis	Functional Reach Test	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Patients with Multiple Sclerosis	Four Square Step Test	Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)
Healthy Controls	Static Balance Test	Healthy people

Primary Outcome Measures

Name	Time	Method
Static Balance Test	5 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	15 minutes	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.
Timed Up and Go Test	1 minutes	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.
Four Square Step Test	1 minutes	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.
One-leg Stance Test	5 minutes	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.
Functional Reach Test	30 seconds	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.