Reliability and ValidityNCT04753411
The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
An observational study of Reliability and Validity, run by Firat University.
Trial summary
The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reliability and Validity
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2021to 4 May 2021
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Individuals who applied to Fırat University Training and Research Hospital and diagnosed with MS by a neurologist will be included.
Who may be able to join
- Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included.
Who cannot join
- Exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.
About this study
Official title: Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients.
Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.
The sample size, according to Lexell and Downham (2005), 40-50 participants should be included in reliability studies. Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.
Read the detailed description
The methodological model of the study is the validity and reliability study. Individuals who applied to Fırat University Training and Research Hospital after ethical approval and diagnosed with MS by a neurologist will be included in our study. It is planned to collect data from individuals who meet the inclusion criteria on a voluntary basis with the Helsinki Declaration. As demographic characteristics; Patients' age, gender, body weight, height, EDSS score, occupation and education status, as a history of the disease, the number of falls in the last year and the type of MS will be recorded. Inclusion criteria for the volunteers; Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included. Also exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.
Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.
The sample size, according to Lexell and Downham, 30-50 participants should be included in reliability studies . Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.
Statistical analysis SPSS for Windows 20.00 computer package program will be used for all statistical analyzes. Descriptive statistical information will be given as mean ± standard deviation (x ± SD) or%. Interclass Correlation Coefficients (ICC) and Cronbach's coefficients values will be examined for the reliability and internal consistency of 3MGDYT. The data will be analyzed with appropriate statistical methods and the statistical significance level will be accepted as p <0.05.
- Conditions
- Reliability and Validity
- Keywords
- Multiple Sclerosis, Balance, Backward
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Meter Backward Walking Test
The 3-meter distance is marked with a black tape and the participants are asked to align their heels with black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. The evaluation will take place three times and the average time will be recorded.
Measured: 2 weeks
Berg Balance Scale
It was designed for quantitative evaluation of balance and determination of fall risk, and was chosen because it evaluates individuals' ability to maintain their balance while performing functional activities. According to the scores obtained from the test in question, the cases were divided into groups as "high fall risk (0-20 points)", "medium fall risk (21-40 points)", "low fall risk (41-56)". score) ". Fifty-six, the highest score, is considered to show the best balance. Turkish validity and reliability study of the scale was conducted by Şahin et al.
Measured: 1 day
Timed Get Up and Go Test
It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit on a chair. The patient is then asked to stand up, walk regularly at a predetermined distance of 3 meters, return at the end of 3 meters and sit on a chair. The walking time of the patient during the test is recorded with the stopwatch in seconds. The test was repeated three times and the average value will be recorded
Measured: 1 day
4-Square Step Test
Aims to evaluate dynamic balance and stepping forward, side and back over objects. Using tape, 1 horizontal and 1 vertical line is made in the form of diagonal 4 divisions. At the start of the test, the individual stands in the upper left square. Then they step clockwise with both feet before moving on to the next frame: first to the right, then back, then to the left, and finally to the back position. They immediately follow this by stepping counterclockwise. After 1 application attempt, the time is saved for the next 2 attempts and the best 1 attempt is counted. Among older adults living in the community, over 15 seconds has been associated with an increased risk of falling
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start5 Feb 2021 (estimated)
- Primary completion4 Apr 2021 (estimated)
- Study completion4 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Reliability and ValidityStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753411
- Sponsor's protocol ID
- Firat U
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
PubMed 16510748Pelfrey CM, Cotleur AC, Lee JC, Rudick RA. Sex differences in cytokine responses to myelin peptides in multiple sclerosis. J Neuroimmunol. 2002 Sep;130(1-2):211-23. doi: 10.1016/s0165-5728(02)00224-2.
PubMed 12225904Frzovic D, Morris ME, Vowels L. Clinical tests of standing balance: performance of persons with multiple sclerosis. Arch Phys Med Rehabil. 2000 Feb;81(2):215-21. doi: 10.1016/s0003-9993(00)90144-8.
PubMed 10668778Williams NP, Roland PS, Yellin W. Vestibular evaluation in patients with early multiple sclerosis. Am J Otol. 1997 Jan;18(1):93-100.
PubMed 8989958Daley ML, Swank RL. Quantitative posturography: use in multiple sclerosis. IEEE Trans Biomed Eng. 1981 Sep;28(9):668-71. doi: 10.1109/TBME.1981.324761. No abstract available.
PubMed 7319527Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.
PubMed 14966714Cattaneo D, De Nuzzo C, Fascia T, Macalli M, Pisoni I, Cardini R. Risks of falls in subjects with multiple sclerosis. Arch Phys Med Rehabil. 2002 Jun;83(6):864-7. doi: 10.1053/apmr.2002.32825.
PubMed 12048669DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):290-7. doi: 10.1016/j.apmr.2003.06.003.
PubMed 14966716Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
PubMed 12525714Tesio L, Perucca L, Franchignoni FP, Battaglia MA. A short measure of balance in multiple sclerosis: validation through Rasch analysis. Funct Neurol. 1997 Sep-Oct;12(5):255-65.
PubMed 9439943Thomas MA, Fast A. One step forward and two steps back: the dangers of walking backwards in therapy. Am J Phys Med Rehabil. 2000 Sep-Oct;79(5):459-61. doi: 10.1097/00002060-200009000-00011.
PubMed 10994888Carter 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 29095771Rose DK, DeMark L, Fox EJ, Clark DJ, Wludyka P. A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. J Neurol Phys Ther. 2018 Jan;42(1):12-21. doi: 10.1097/NPT.0000000000000210.
PubMed 29232308Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13.
PubMed 33197801Lexell JE, Downham DY. How to assess the reliability of measurements in rehabilitation. Am J Phys Med Rehabil. 2005 Sep;84(9):719-23. doi: 10.1097/01.phm.0000176452.17771.20.
PubMed 16141752
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04753411
- Acronym / sponsor ID
- Firat U
- Conditions
- Reliability and Validity
- Keywords
- Multiple Sclerosis, Balance, Backward
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (estimated)
- Primary completion
- 4 Apr 2021 (estimated)
- Study completion
- 4 May 2021 (estimated)
- First posted
- 15 Feb 2021 (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.
The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients.
Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.
The sample size, according to Lexell and Downham (2005), 40-50 participants should be included in reliability studies. Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.
Detailed description
The methodological model of the study is the validity and reliability study. Individuals who applied to Fırat University Training and Research Hospital after ethical approval and diagnosed with MS by a neurologist will be included in our study. It is planned to collect data from individuals who meet the inclusion criteria on a voluntary basis with the Helsinki Declaration. As demographic characteristics; Patients' age, gender, body weight, height, EDSS score, occupation and education status, as a history of the disease, the number of falls in the last year and the type of MS will be recorded. Inclusion criteria for the volunteers; Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included. Also exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.
Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations.
The sample size, according to Lexell and Downham, 30-50 participants should be included in reliability studies . Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.
Statistical analysis SPSS for Windows 20.00 computer package program will be used for all statistical analyzes. Descriptive statistical information will be given as mean ± standard deviation (x ± SD) or%. Interclass Correlation Coefficients (ICC) and Cronbach's coefficients values will be examined for the reliability and internal consistency of 3MGDYT. The data will be analyzed with appropriate statistical methods and the statistical significance level will be accepted as p <0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals who applied to Fırat University Training and Research Hospital and diagnosed with MS by a neurologist will be included.
Key inclusion criteria (1 listed)
- Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included.
Key exclusion criteria (1 listed)
- Exclusion criteria for volunteers; High level spasticity of the lower limbs (Ashworth score 3 or 4), who had an acute MS attack or had a history of an attack within the last 1 month, had orthopedic or systemic problems that prevented participation in tests, had another known neuromuscular disorder other than MS, had visual involvement or diplopia, and Having a cardio-pulmonary problem that will prevent him from participating in tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3 Meter Backward Walking Test
Time frame: 2 weeks
The 3-meter distance is marked with a black tape and the participants are asked to align their heels with black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. The evaluation will take place three times and the average time will be recorded.
Berg Balance Scale
Time frame: 1 day
It was designed for quantitative evaluation of balance and determination of fall risk, and was chosen because it evaluates individuals' ability to maintain their balance while performing functional activities. According to the scores obtained from the test in question, the cases were divided into groups as "high fall risk (0-20 points)", "medium fall risk (21-40 points)", "low fall risk (41-56)". score) ". Fifty-six, the highest score, is considered to show the best balance. Turkish validity and reliability study of the scale was conducted by Şahin et al.
Timed Get Up and Go Test
Time frame: 1 day
It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit on a chair. The patient is then asked to stand up, walk regularly at a predetermined distance of 3 meters, return at the end of 3 meters and sit on a chair. The walking time of the patient during the test is recorded with the stopwatch in seconds. The test was repeated three times and the average value will be recorded
4-Square Step Test
Time frame: 1 day
Aims to evaluate dynamic balance and stepping forward, side and back over objects. Using tape, 1 horizontal and 1 vertical line is made in the form of diagonal 4 divisions. At the start of the test, the individual stands in the upper left square. Then they step clockwise with both feet before moving on to the next frame: first to the right, then back, then to the left, and finally to the back position. They immediately follow this by stepping counterclockwise. After 1 application attempt, the time is saved for the next 2 attempts and the best 1 attempt is counted. Among older adults living in the community, over 15 seconds has been associated with an increased risk of falling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 16510748Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
- Background: PubMed 12225904Pelfrey CM, Cotleur AC, Lee JC, Rudick RA. Sex differences in cytokine responses to myelin peptides in multiple sclerosis. J Neuroimmunol. 2002 Sep;130(1-2):211-23. doi: 10.1016/s0165-5728(02)00224-2.
- Background: PubMed 10668778Frzovic D, Morris ME, Vowels L. Clinical tests of standing balance: performance of persons with multiple sclerosis. Arch Phys Med Rehabil. 2000 Feb;81(2):215-21. doi: 10.1016/s0003-9993(00)90144-8.
- Background: PubMed 8989958Williams NP, Roland PS, Yellin W. Vestibular evaluation in patients with early multiple sclerosis. Am J Otol. 1997 Jan;18(1):93-100.
- Background: PubMed 7319527Daley ML, Swank RL. Quantitative posturography: use in multiple sclerosis. IEEE Trans Biomed Eng. 1981 Sep;28(9):668-71. doi: 10.1109/TBME.1981.324761. No abstract available.
- Background: PubMed 14966714Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.
- Background: PubMed 12048669Cattaneo D, De Nuzzo C, Fascia T, Macalli M, Pisoni I, Cardini R. Risks of falls in subjects with multiple sclerosis. Arch Phys Med Rehabil. 2002 Jun;83(6):864-7. doi: 10.1053/apmr.2002.32825.
- Background: PubMed 14966716DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):290-7. doi: 10.1016/j.apmr.2003.06.003.
- Background: PubMed 12525714Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
- Background: PubMed 9439943Tesio L, Perucca L, Franchignoni FP, Battaglia MA. A short measure of balance in multiple sclerosis: validation through Rasch analysis. Funct Neurol. 1997 Sep-Oct;12(5):255-65.
- Background: PubMed 10994888Thomas MA, Fast A. One step forward and two steps back: the dangers of walking backwards in therapy. Am J Phys Med Rehabil. 2000 Sep-Oct;79(5):459-61. doi: 10.1097/00002060-200009000-00011.
- 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.
- Individual participant dataSharing planned: 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reliability and Validity, run by Firat University.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 Meter Backward Walking Test (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 NCT04753411, which also lists 18 linked publications.
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 15 Feb 2021.