NCT03718026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

23 days

First QC Date

October 22, 2018

Last Update Submit

November 19, 2018

Conditions

Keywords

The timed 360° turn testMultiple sclerosisreliabilityvalidity

Outcome Measures

Primary Outcomes (1)

  • The timed 360° turn test

    The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance.

    1 minute

Secondary Outcomes (5)

  • Berg Balance Scale

    10 minutes

  • Timed Up and Go test

    1 minute

  • Functional Reach Test

    1 minute

  • Four Square Step Test

    1 minute

  • One Leg Stance Test

    3 minutes

Study Arms (2)

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

Healthy Controls

-The timed 360° turn test

Other: The timed 360° turn test

Interventions

* 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.

Also known as: Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test
Healthy ControlsPatients with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

You may qualify if:

  • 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.

You may not qualify if:

  • other neurologic disorder,
  • Pregnancy,
  • orhopedic problems affecting gait and stance,
  • visual, auditory, orientational problems that could affect study results,
  • Cardiovascular, pulmonary, and humoral disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Söke

Ankara, 06560, Turkey (Türkiye)

Location

Related 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.

    PMID: 29879144BACKGROUND
  • 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.

    PMID: 22277368BACKGROUND
  • 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.

    PMID: 24055784BACKGROUND
  • 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.

    PMID: 23391522BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fatih Söke

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

October 24, 2018

Primary Completion

November 16, 2018

Study Completion

November 19, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations