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

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

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Fatih Söke, Gazi University

Publications and helpful links

General Publications

• Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
• McConvey J, Bennett SE. Reliability of the Dynamic Gait Index in individuals with multiple sclerosis. Arch Phys Med Rehabil. 2005 Jan;86(1):130-3. doi: 10.1016/j.apmr.2003.11.033.
• Gijbels D, Alders G, Van Hoof E, Charlier C, Roelants M, Broekmans T, Eijnde BO, Feys P. Predicting habitual walking performance in multiple sclerosis: relevance of capacity and self-report measures. Mult Scler. 2010 May;16(5):618-26. doi: 10.1177/1352458510361357. Epub 2010 Mar 5.
• Matsuda PN, Shumway-Cook A, Bamer AM, Johnson SL, Amtmann D, Kraft GH. Falls in multiple sclerosis. PM R. 2011 Jul;3(7):624-32; quiz 632. doi: 10.1016/j.pmrj.2011.04.015.
• Suzuki M, Fujisawa H, Machida Y, Minakata S. Relationship between the Berg Balance Scale and Static Balance Test in Hemiplegic Patients with Stroke. J Phys Ther Sci. 2013 Aug;25(8):1043-9. doi: 10.1589/jpts.25.1043. Epub 2013 Sep 20.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 5, 2018
• Primary Completion (Anticipated): August 20, 2018
• Study Completion (Anticipated): August 30, 2018

Study Registration Dates

• First Submitted: June 30, 2018
• First Submitted That Met QC Criteria: June 30, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Balance; Validity; Reliability; Static Balance Test
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No