- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04004026
3 Meter Backwards Walk Test and Multiple Sclerosis
April 11, 2021 updated by: zekiye ipek katırcı kırmacı, Sanko University
The Validity and Reliability of 3 Meter Backwards Walk Test in Multiple Sclerosis Patients
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Gait and mobility are frequently affected functions in MS and have a negative impact on quality of life.
Approximately 40% of patients describe walking problems and 70% of individuals in this group are reported to be affected by daily living activities.
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.
Therefore, determining the performance-based fall risk of these patients is important in terms of establishing a rehabilitation program and evaluating the treatment results.
In this context, researchers have recently reported that assessment of backward gait may be an important clinical tool to determine the risk of falling, especially in individuals with balance problems.
However, it has not been investigated whether backward gait is often associated with performance and balance tests in individuals with MS who have balance problems.
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Şehitkamil
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Gaziantep, Şehitkamil, Turkey, 27090
- Sanko University
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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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Multiple Sclerosis patient
Description
Inclusion Criteria:
- EDSS score is 4 or less,
Exclusion Criteria:
- 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
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Multiple sclerosis patient
First day, first evaluator will perform all tests, and second day, second evaluator will perform 3 m backwards walk test.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3 m backwards walk test
Time Frame: First and second days
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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
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First and second days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed up and go test
Time Frame: First day
|
At the beginning of the test, individuals sit in a chair.
A distance of 3 m is determined in front of it.
With the start command, he gets up from his seat and walks for 3 m and turns around and walks back and sits.
With the Start command, the time in seconds until the seat is fully seated.
A shorter duration means that functional mobility is good.
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First day
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12 Items MS Walking Scale
Time Frame: First day
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It is a 12-item questionnaire that questions the effect of gait in MS.
The difficulties experienced by individuals during walking activity during the last 2 weeks are questioned.
Each item contains 5 points (1; I am not affected at all; 5; I am fully impressed).
Low scores indicate better gait disturbance
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First day
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2 min walk test
Time Frame: First day
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Individuals are asked to walk as fast as possible without running in a 25 m corridor.
The distance they walk for 2 minutes is recorded.
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First day
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25 foot walk test
Time Frame: First day
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It is an evaluation to evaluate mobility and leg functions.
Individuals are asked to walk safely on a flat surface at the highest speed of 7.62 m.
Individuals are allowed to use walking aids if necessary.
Individuals are asked to walk 3 times.
The average of the times is recorded.
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First day
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4 square step test
Time Frame: First day
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It aims to evaluate dynamic balance and to step forward, sideways and backwards of objects.
The square drawn on the floor is divided into 4 equal parts.
The number 1 is written in the lower right corner, up to 4 clockwise.
With the Start command, individuals are asked to press on the numbers respectively.
It is first asked to take a step forward (number 1 and 2) then left (number 3), then backward (number 4).
It is then asked to take steps 4 through 1 again.
The time is saved.
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First day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zekiye İpek Katırcı Kırmacı, Ph.D(c), Sanko 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.
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 (Actual)
July 1, 2019
Primary Completion (Actual)
April 15, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
June 27, 2019
First Posted (Actual)
July 1, 2019
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 11, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SankoU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Undecided
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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