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出境医 / 临床实验 / 3 Meter Backwards Walk Test and Multiple Sclerosis
3 Meter Backwards Walk Test and Multiple Sclerosis
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Sclerosis Walking, Difficulty Balance; Distorted | Other: Assesment |
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 Design
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 40 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | The Validity and Reliability of 3 Meter Backwards Walk Test in Multiple Sclerosis Patients |
| Actual Study Start Date : | July 1, 2019 |
| Actual Primary Completion Date : | April 15, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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.
|
Outcome Measures
Primary Outcome Measures :
- 3 m backwards walk test [ Time Frame: First and second days ]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
Secondary Outcome Measures :
- 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.
- 12 Items MS Walking Scale [ Time Frame: First day ]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
- 2 min walk test [ Time Frame: First day ]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.
- 25 foot walk test [ Time Frame: First day ]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.
- 4 square step test [ Time Frame: First day ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Multiple Sclerosis patient
Criteria
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
Contacts and Locations
Locations
| Turkey | |
| SANKO University | |
| Gaziantep, Şehitkamil, Turkey, 27090 | |
Sponsors and Collaborators
Sanko University
Investigators
| Principal Investigator: | Zekiye İpek Katırcı Kırmacı, Ph.D(c) | Sanko University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 27, 2019 | ||||
| First Posted Date | July 1, 2019 | ||||
| Last Update Posted Date | April 14, 2021 | ||||
| Actual Study Start Date | July 1, 2019 | ||||
| Actual Primary Completion Date | April 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
3 m backwards walk test [ Time Frame: First and second days ] 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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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 3 Meter Backwards Walk Test and Multiple Sclerosis | ||||
| Official Title | The Validity and Reliability of 3 Meter Backwards Walk Test in Multiple Sclerosis Patients | ||||
| 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. | ||||
| 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 [Patient Registry] | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | 1 Day | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Multiple Sclerosis patient | ||||
| Condition |
|
||||
| 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.
|
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| Study Groups/Cohorts | Multiple sclerosis patient
First day, first evaluator will perform all tests, and second day, second evaluator will perform 3 m backwards walk test.
Intervention: Other: Assesment
|
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
40 | ||||
| Original Estimated Enrollment |
45 | ||||
| Actual Study Completion Date | June 30, 2020 | ||||
| Actual Primary Completion Date | April 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04004026 | ||||
| Other Study ID Numbers | SankoU | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | zekiye ipek katırcı kırmacı, Kahramanmaras Sutcu Imam University | ||||
| Study Sponsor | Sanko University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Sanko University | ||||
| Verification Date | April 2021 | ||||
