Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test Test in Patients With Multiple Sclerosis
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 |
Verified date | November 2018 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Fatih Söke | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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
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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