NCT04004026

Brief Summary

Multiple Sclerosis (MS) is an autoimmune, demyelinating disease of the central nervous system that causes different levels of disability with motor and sensory loss. Although the signs and symptoms of the disease vary according to the location of the lesion; loss of strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction and decreased visual acuity are frequently seen. One of the most important causes of loss of function is balance problems. Balance problems, on the other hand, result in falls that cause severe injuries. One of the most important goals in the rehabilitation of individuals with MS is to increase their performance by minimizing the risk of falling in their daily lives. For medical professionals, many medical history questionnaires, self-assessment measures and performance-based tests have been developed to determine the risk of falls. Performance-based functional assessments consist of a timed walk and walk test, functional skill, balance and fall risk, 5 times sit-and-go test and Berg Balance Test, 4 square step test and gait speed measurement tests. These tests include the ability to walk forward and revolve around ones priorities. However, walking is a more difficult activity as it involves neuromuscular control and is dependent on proprioception and protective reflexes. In daily life activities, there is a need to walk backwards to perform tasks such as leaning against a chair and opening the door. This movement can be quite challenging especially for elderly people with neurological deficits. It has been noted that the mechanical measurements of the back support, in particular the speed, the step length, and the double support surface are significantly reduced in older adults. In a study conducted in geriatric individuals, it was shown that walking backward was more sensitive to detect age-related changes in mobility and balance than walking forward. The aim of this study is to determine the validity and reliability of the 3-meter backwards walk test for evaluating performance-based fall risk in individuals with MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

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

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

June 27, 2019

Last Update Submit

April 11, 2021

Conditions

Keywords

Multiple Sclerosis3-m backwards walkBalanceFall riskvalidityreliability

Outcome Measures

Primary Outcomes (1)

  • 3 m backwards walk test

    465/5000 A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band. With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded

    First and second days

Secondary Outcomes (5)

  • Timed up and go test

    First day

  • 12 Items MS Walking Scale

    First day

  • 2 min walk test

    First day

  • 25 foot walk test

    First day

  • 4 square step test

    First day

Study Arms (1)

Multiple sclerosis patient

First day, first evaluator will perform all tests, and second day, second evaluator will perform 3 m backwards walk test.

Other: Assesment

Interventions

3-m backwards walk test, timed up and go test, 12-item MS Walking Scale, 2-min walk test, timed 25-foot walk test, 4-square step test.

Multiple sclerosis patient

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Multiple Sclerosis patient

You may qualify if:

  • EDSS score is 4 or less,

You may not qualify if:

  • Pregnancy or in the first 3 months after birth,
  • Corticosteroid treatment in the last month
  • Using medication that will affect walking in the last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO University

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

Related Publications (1)

  • Carter V, Jain T, James J, Cornwall M, Aldrich A, de Heer HD. The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):249-255. doi: 10.1519/JPT.0000000000000149.

    PMID: 29095771BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple SclerosisMobility Limitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zekiye İpek Katırcı Kırmacı, Ph.D(c)

    Sanko University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

July 1, 2019

Primary Completion

April 15, 2020

Study Completion

June 30, 2020

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations