Multiple SclerosisNCT04004026
3 Meter Backwards Walk Test and Multiple Sclerosis
An observational study of Multiple Sclerosis and Walking, Difficulty, run by Sanko University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Walking, Difficulty, Balance; Distorted
- What is being tested?
- Assesment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Jun 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Multiple Sclerosis patient
Who may be able to join
- EDSS score is 4 or less,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Walking, Difficulty, Balance; Distorted
- Being tested
- Assesment
- Keywords
- Multiple Sclerosis, 3-m backwards walk, Balance, Fall risk, validity, reliability
- Medical subject headings
- Multiple Sclerosis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patient | First day, first evaluator will perform all tests, and second day, second evaluator will perform 3 m backwards walk test. Receives: Other: Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First and second days
Secondary outcomes (5)
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.
Measured: First day
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
Measured: First day
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.
Measured: First day
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.
Measured: First day
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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jul 2019
- Primary completion15 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zekiye ipek katırcı kırmacı, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Ph.D(c), Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004026
- Sponsor's protocol ID
- SankoU
- Status last verified
- Apr 2021
- First submitted
- 27 Jun 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- Individual data sharing
- Undecided: Undecided
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.
PubMed 29095771
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of 3 Meter Backwards Walk Test in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04004026
- Acronym / sponsor ID
- SankoU
- Conditions
- Multiple Sclerosis, Walking, Difficulty, Balance; Distorted
- Keywords
- Multiple Sclerosis, 3-m backwards walk, Balance, Fall risk, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patient | – | Other: AssesmentFirst day, first evaluator will perform all tests, and second day, second evaluator will perform 3 m backwards walk test. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Multiple Sclerosis patient
Key inclusion criteria (1 listed)
- EDSS score is 4 or less,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment3-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. | Other | Multiple sclerosis patient |
Primary outcome
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
5 secondary outcomes
Timed up and go test
Time frame: First day
12 Items MS Walking Scale
Time frame: First day
2 min walk test
Time frame: First day
25 foot walk test
Time frame: First day
4 square step test
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 29095771Carter 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.
- The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye İpek Katırcı Kırmacı, Ph.D(c) principal investigator
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Walking, Difficulty, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 m backwards walk test (time frame: First and second days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.