The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis

February 10, 2021 updated by: Furkan BİLEK, Firat University

Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis

The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients.

Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.

The sample size, according to Lexell and Downham (2005), 40-50 participants should be included in reliability studies. Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.

Study Overview

Status

Unknown

Conditions

Detailed Description

The methodological model of the study is the validity and reliability study. Individuals who applied to Fırat University Training and Research Hospital after ethical approval and diagnosed with MS by a neurologist will be included in our study. It is planned to collect data from individuals who meet the inclusion criteria on a voluntary basis with the Helsinki Declaration. As demographic characteristics; Patients' age, gender, body weight, height, EDSS score, occupation and education status, as a history of the disease, the number of falls in the last year and the type of MS will be recorded. Inclusion criteria for the volunteers; Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included. Also exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.

Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.

The sample size, according to Lexell and Downham, 30-50 participants should be included in reliability studies . Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.

Statistical analysis SPSS for Windows 20.00 computer package program will be used for all statistical analyzes. Descriptive statistical information will be given as mean ± standard deviation (x ± SD) or%. Interclass Correlation Coefficients (ICC) and Cronbach's coefficients values will be examined for the reliability and internal consistency of 3MGDYT. The data will be analyzed with appropriate statistical methods and the statistical significance level will be accepted as p <0.05.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals who applied to Fırat University Training and Research Hospital and diagnosed with MS by a neurologist will be included.

Description

Inclusion Criteria:

  • Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included.

Exclusion Criteria:

  • Exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Meter Backward Walking Test
Time Frame: 2 weeks
The 3-meter distance is marked with a black tape and the participants are asked to align their heels with black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. The evaluation will take place three times and the average time will be recorded.
2 weeks
Berg Balance Scale
Time Frame: 1 day
It was designed for quantitative evaluation of balance and determination of fall risk, and was chosen because it evaluates individuals' ability to maintain their balance while performing functional activities. According to the scores obtained from the test in question, the cases were divided into groups as "high fall risk (0-20 points)", "medium fall risk (21-40 points)", "low fall risk (41-56)". score) ". Fifty-six, the highest score, is considered to show the best balance. Turkish validity and reliability study of the scale was conducted by Şahin et al.
1 day
Timed Get Up and Go Test
Time Frame: 1 day
It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit on a chair. The patient is then asked to stand up, walk regularly at a predetermined distance of 3 meters, return at the end of 3 meters and sit on a chair. The walking time of the patient during the test is recorded with the stopwatch in seconds. The test was repeated three times and the average value will be recorded
1 day
4-Square Step Test
Time Frame: 1 day
Aims to evaluate dynamic balance and stepping forward, side and back over objects. Using tape, 1 horizontal and 1 vertical line is made in the form of diagonal 4 divisions. At the start of the test, the individual stands in the upper left square. Then they step clockwise with both feet before moving on to the next frame: first to the right, then back, then to the left, and finally to the back position. They immediately follow this by stepping counterclockwise. After 1 application attempt, the time is saved for the next 2 attempts and the best 1 attempt is counted. Among older adults living in the community, over 15 seconds has been associated with an increased risk of falling
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 5, 2021

Primary Completion (Anticipated)

April 4, 2021

Study Completion (Anticipated)

May 4, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Firat U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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