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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Fatih Söke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The timed 360° turn test	The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Timed Up and Go test	Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.	1 minute
Functional Reach Test	Functional Reach Test is used to evaluate limits of stability. Higher distances indicate better limits of stability.	1 minute
Four Square Step Test	Four Square Step Test is used to assess dynamic balance. Higher durations indicate worse dynamic balance.	1 minute
One Leg Stance Test	One Leg Stance Test evaluates postural stability. Higher durations indicate better postural stability.	3 minutes

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Fatih Söke, Gazi University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 19, 2018

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Multiple sclerosis; validity; reliability; The timed 360° turn test
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No