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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03718026
Other study ID # 438
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 24, 2018
Est. completion date November 19, 2018

Study information

Verified date November 2018
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis.


Description:

At baseline, the timed 360° turn 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 timed 360° turn test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the timed 360° turn test.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date November 19, 2018
Est. primary completion date November 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
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,

- orhopedic 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:
The timed 360° turn test
The timed 360° turn test: Each participant turns around in place in a standing position for both sides. Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment). Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again. Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support. One-leg stance test: Individuals were asked to stand on either their left or right leg. Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways.

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 (4)

Adusumilli G, Lancia S, Levasseur VA, Amblee V, Orchard M, Wagner JM, Naismith RT. Turning is an important marker of balance confidence and walking limitation in persons with multiple sclerosis. PLoS One. 2018 Jun 7;13(6):e0198178. doi: 10.1371/journal.pone.0198178. eCollection 2018. — View Citation

Cameron MH, Asano M, Bourdette D, Finlayson ML. People with multiple sclerosis use many fall prevention strategies but still fall frequently. Arch Phys Med Rehabil. 2013 Aug;94(8):1562-6. doi: 10.1016/j.apmr.2013.01.021. Epub 2013 Feb 4. — View Citation

Gunn H, Creanor S, Haas B, Marsden J, Freeman J. Frequency, characteristics, and consequences of falls in multiple sclerosis: findings from a cohort study. Arch Phys Med Rehabil. 2014 Mar;95(3):538-45. doi: 10.1016/j.apmr.2013.08.244. Epub 2013 Sep 18. — View Citation

Spain RI, St George RJ, Salarian A, Mancini M, Wagner JM, Horak FB, Bourdette D. Body-worn motion sensors detect balance and gait deficits in people with multiple sclerosis who have normal walking speed. Gait Posture. 2012 Apr;35(4):573-8. doi: 10.1016/j.gaitpost.2011.11.026. Epub 2012 Jan 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The timed 360° turn test The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance. 1 minute
Secondary Berg Balance Scale Berg Balance Scale assesses functional balance. It consists of 14 functional tasks rated on a 5-point scale ranging from 0 to 4. The maximum score is 56 points. Higher scores indicate better functional balance. 10 minutes
Secondary Timed Up and Go test Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility. 1 minute
Secondary Functional Reach Test Functional Reach Test is used to evaluate limits of stability. Higher distances indicate better limits of stability. 1 minute
Secondary Four Square Step Test Four Square Step Test is used to assess dynamic balance. Higher durations indicate worse dynamic balance. 1 minute
Secondary One Leg Stance Test One Leg Stance Test evaluates postural stability. Higher durations indicate better postural stability. 3 minutes
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