Multiple Sclerosis Clinical Trial
Official title:
The Validity and Reliability of 3 Meter Backwards Walk Test in Multiple Sclerosis Patients
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 |
Verified date | April 2021 |
Source | Sanko University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | SANKO University | Gaziantep | Sehitkamil |
Lead Sponsor | Collaborator |
---|---|
Sanko University |
Turkey,
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
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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