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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03584672
• Other study ID #: 322
• Status: Not yet recruiting
• Start date: August 5, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: July 2018
• Source: Gazi University
• Contact: Faith Söke
• Phone: +90 506 932 81 02
• Email: fthsk_8993[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 30, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Static Balance Test
Balance control is assessed by the Static Balance Test.
• Berg Balance Scale
Functional balance is assessed by the Berg Balance Scale.
• Timed Up an Go Test
Functional mobility is assessed by the Timed Up and Go test.
• Four Square Step Test
Dynamic balance is assessed by the Four Square Step Test.
• Functional Reach Test
Limits of stability is assessed by the Functional Reach Test.
• One-leg Stance Test
Postural steadiness is assessed by the One-leg Stance Test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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