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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04185688
Other study ID # 2019-153
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 6, 2019
Est. completion date February 7, 2020

Study information

Verified date April 2020
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Loss of limits of stability ability is one of the major components of balance dysfunction in MS. The functional reach test is quick and clinically available tool for assessing limits of stability but reliability and validity of this test has not yet been systematically examined in people with Multiple Sclerosis.The aim of the study is to investigate reliability and validity of the functional reach test in patients with Multiple Sclerosis.


Description:

At baseline, the functional reach test, limits of stability test by using Biodex Balance System, Berg Balance Scale, four step square test, and timed up and go test was applied to the patients with Multiple Sclerosis. The functional reach test was repeated after seven days from the first application to evaluate its reliability.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date February 7, 2020
Est. primary completion date February 7, 2020
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 20 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,

- orthopedic problems affecting gait and stance,

- visual, auditory, orientational problems that could affect study results,

- cardiovascular, pulmonary, and humoral disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Functional Reach Test
The Functional Reach Test assesses balance by measuring the limits of stability while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.

Locations

Country Name City State
Turkey Fatih Söke Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X. Review. — View Citation

Duncan PW, Studenski S, Chandler J, Prescott B. Functional reach: predictive validity in a sample of elderly male veterans. J Gerontol. 1992 May;47(3):M93-8. — View Citation

Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. — View Citation

Ganesan M, Kanekar N, Aruin AS. Direction-specific impairments of limits of stability in individuals with multiple sclerosis. Ann Phys Rehabil Med. 2015 Jun;58(3):145-50. doi: 10.1016/j.rehab.2015.04.002. Epub 2015 May 8. — View Citation

Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830. — View Citation

Lynch SM, Leahy P, Barker SP. Reliability of measurements obtained with a modified functional reach test in subjects with spinal cord injury. Phys Ther. 1998 Feb;78(2):128-33. — View Citation

Martins EF, de Menezes LT, de Sousa PH, de Araujo Barbosa PH, Costa AS. Reliability of the Functional Reach Test and the influence of anthropometric characteristics on test results in subjects with hemiparesis. NeuroRehabilitation. 2012;31(2):161-9. doi: 10.3233/NRE-2012-0786. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Reach Test Functional Reach Test is clinically used to assess limits of stability. 30 seconds
Secondary Biodex Balance System Biodex Balance System is used to assess limits of stability. 2 minutes
Secondary Berg Balance Scale Berg Balance Scale is used to assess functional balance. Berg Balance Scale is a 14-item related to daily living activities that is scored between 0 and 4. The maximum score is 56 points and higher scores represent better balance. 10 minutes
Secondary Four Square Step Test Four Square Step Test is used to assess dynamic balance. 20 seconds
Secondary Timed Up and Go Test Timed Up and Go Test is used to assess functional mobility. 15 seconds
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