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The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03718026
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Fatih Söke, Gazi University

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

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Other: The timed 360° turn test

Detailed 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.

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test Test in Patients With Multiple Sclerosis
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Multiple Sclerosis
  • The timed 360° turn test
  • Berg Balance Scale
  • Timed Up and Go test
  • Functional Reach Test
  • One-leg stance test
  • Four square step test
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.
Other Name: Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test

Healthy Controls
-The timed 360° turn test
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.
Other Name: Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test




Primary Outcome Measures :
  1. The timed 360° turn test [ Time Frame: 1 minute ]
    The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance.


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 10 minutes ]
    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.

  2. Timed Up and Go test [ Time Frame: 1 minute ]
    Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.

  3. Functional Reach Test [ Time Frame: 1 minute ]
    Functional Reach Test is used to evaluate limits of stability. Higher distances indicate better limits of stability.

  4. Four Square Step Test [ Time Frame: 1 minute ]
    Four Square Step Test is used to assess dynamic balance. Higher durations indicate worse dynamic balance.

  5. One Leg Stance Test [ Time Frame: 3 minutes ]
    One Leg Stance Test evaluates postural stability. Higher durations indicate better postural stability.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718026


Locations
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Turkey
Fatih Söke
Ankara, Turkey, 06560
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Fatih Söke Gazi University

Publications:
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Responsible Party: Fatih Söke, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03718026     History of Changes
Other Study ID Numbers: 438
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Fatih Söke, Gazi University:
The timed 360° turn test
Multiple sclerosis
reliability
validity

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases