Multiple Sclerosis Clinical Trial
Official title:
The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis
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 |
Verified date | April 2020 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Fatih Söke | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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
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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