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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04004026
Other study ID # SankoU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date June 30, 2020

Study information

Verified date April 2021
Source Sanko University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Other:
Assesment
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.

Locations

Country Name City State
Turkey SANKO University Gaziantep Sehitkamil

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Timed up and go test 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. First day
Secondary 12 Items MS Walking Scale 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 First day
Secondary 2 min walk test 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. First day
Secondary 25 foot walk test 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. First day
Secondary 4 square step test 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. First day
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