StrokeNCT04919772
Assessing the Reliability and Validity of 4-meter and 10-meter Walking Test
An observational study of Stroke and Gait, Hemiplegic, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The 4-meter walk test and 10-meter walk test is currently applied to assess gait speed.These tools are frequently used in clinical trials and were also shown to be reliable measurement methods. There are ocassions where it is not possible to have a long corridor to measure gait speed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait, Hemiplegic, Cerebral Infarction
- What is being tested?
- Assessment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke survivors in chronic phase > 6 months
Who may be able to join
- All study participants are clinically diagnosed with stroke
- Adult participants, defined as >18 years of age
- Have preserved cognitive ability: Achieve a score equal to or greater than 25 points on the Montreal Cognitive Assessment test.
- Have the ability to walk on a flat surface of at least 20 meters, with or without aid.
Who cannot join
- A history of lower extremities injury or surgery
- A history of botulinum injection within 3 months
- A history of inflammatory arthritis
- A history of inflammatory myopathy or peripheral nervous disease
- A history of other neurological disease as a Parkinson, spinal cord etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Reliability and Validity of 4-meter and 10-meter Walking Test for Measurements of Gait Speed and Their Correlation With 5-repetition Sit-to-stand Test in Chronic Stroke Survivors
The 4-meter walk test and 10-meter walk test is currently applied to assess gait speed.These tools are frequently used in clinical trials and were also shown to be reliable measurement methods. There are ocassions where it is not possible to have a long corridor to measure gait speed. It is necessary to have a tool to evaluate gait speed in a small space as 4-meter walk test.
Read the detailed description
Walking speed is an important aspect of gait and is commonly used as an objective measure of functional mobility in both clinical and research settings. The majority who have suffered a stroke tend to have gait disturbances. Regaining locomotor ability is one of the primary goals in stroke rehabilitation, and it is most commonly measured using changes in self-selected walking speed. Although many of them can walk independently, they do not do so with enough speed and endurance to allow them to perform their activities of daily living prior to stroke. Not only is self-selected walking speed simple, cost effective, reliable, valid, sensitive, and specific, but it is also highly related to the severity of impairment and predicts functional walking status. It is recommended as a "vital sign" of health. Improvements in walking speed of 0.1 m/s or more have been shown to be a predictor of good health. However, decreased walking speed has been related to worse health outcomes and frailty in older people.
The 4-meter walk test (4 MWT) and 10-meter walk test (10 MWT) is currently applied using various timing protocols and distance covered that may affect data interpretation with a standard value, and comparisons among the studies. There are two protocols to measure walking speed, static and flying start. A static start (i.e., record the time used to cover a total walkway or from the start to stop walking) or a flying start (i.e., measured the time while walking in the middle of the walkway).
The aim of this study is to investigate the test-retest reliability of the 4 MWT and 10 MWT and their correlation with 5-repetition sit-to-stand in chronic stroke survivors.
- Being tested
- Assessment
- Keywords
- walking speed, gait, sit-to-stand, reliability, validity, correlation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Cerebral Infarction, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called Evaluation
The participants walk 4-meter and 10-meter and 5-repetition sit-to-stand twice.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors | Chronic stroke, generally speaking chronic stroke refers to the period of recovery that takes place at least six months after the initial stroke event Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of 4-meter walking test
Reliability is the overall consistency of a measure.
Measured: Baseline
Reliability of 4-meter walking test
Reliability is the overall consistency of a measure.
Measured: 1 hour later from baseline
Validity of 4-meter walking test
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Measured: Baseline
Validity of 4-meter walking test
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Measured: 1 hour later from baseline
Reliability of 10-meter walking test
Reliability is the overall consistency of a measure.
Measured: Baseline
Reliability of 10-meter walking test
Reliability is the overall consistency of a measure.
Measured: 1 hour later from baseline
Validity of 10-meter walking test
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Measured: Baseline
Validity of 10-meter walking test
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Measured: 1 hour later from baseline
Secondary outcomes (2)
Correlation of 5-repetition sit-to-stand with 4-meter walking test
A rank correlation coefficient measures the degree of similarity between two rankings, and can be used to assess the significance of the relation between them.
Measured: Baseline
Correlation of 5-repetition sit-to-stand with 10-meter walking test
A rank correlation coefficient measures the degree of similarity between two rankings, and can be used to assess the significance of the relation between them.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 May 2021
- Primary completion29 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Responsible party
- Principal investigator, Rosa Cabanas Valdés, Universitat Internacional de Catalunya
- Investigators
- Laura García-Rueda, MsC, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919772
- Sponsor's protocol ID
- 4-meter walking test
- Status last verified
- Jul 2022
- First submitted
- 23 May 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohannon RW. Measurement of gait speed of older adults is feasible and informative in a home-care setting. J Geriatr Phys Ther. 2009;32(1):22-3. doi: 10.1519/00139143-200932010-00005.
PubMed 19856632Karpman C, Lebrasseur NK, Depew ZS, Novotny PJ, Benzo RP. Measuring gait speed in the out-patient clinic: methodology and feasibility. Respir Care. 2014 Apr;59(4):531-7. doi: 10.4187/respcare.02688. Epub 2013 Aug 27.
PubMed 23983271Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Richards CL, Malouin F, Dean C. Gait in stroke: assessment and rehabilitation. Clin Geriatr Med. 1999 Nov;15(4):833-55.
PubMed 10499938Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.
PubMed 17939776Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
PubMed 7811170Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
PubMed 15370761Parker CJ, Gladman JR, Drummond AE. The role of leisure in stroke rehabilitation. Disabil Rehabil. 1997 Jan;19(1):1-5. doi: 10.3109/09638289709166438.
PubMed 9021278Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
PubMed 10811152Awad L, Reisman D, Binder-Macleod S. Distance-Induced Changes in Walking Speed After Stroke: Relationship to Community Walking Activity. J Neurol Phys Ther. 2019 Oct;43(4):220-223. doi: 10.1097/NPT.0000000000000293.
PubMed 31449180Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005 Oct;60(10):1304-9. doi: 10.1093/gerona/60.10.1304.
PubMed 16282564Feld JA, Rabadi MH, Blau AD, Jordan BD. Berg balance scale and outcome measures in acquired brain injury. Neurorehabil Neural Repair. 2001;15(3):239-44. doi: 10.1177/154596830101500312.
PubMed 11944746Taylor-Piliae RE, Latt LD, Hepworth JT, Coull BM. Predictors of gait velocity among community-dwelling stroke survivors. Gait Posture. 2012 Mar;35(3):395-9. doi: 10.1016/j.gaitpost.2011.10.358. Epub 2011 Nov 26.
PubMed 22119886Braden HJ, Hilgenberg S, Bohannon RW, Ko MS, Hasson S. Gait speed is limited but improves over the course of acute care physical therapy. J Geriatr Phys Ther. 2012 Jul-Sep;35(3):140-4. doi: 10.1519/JPT.0b013e31824baa1e.
PubMed 22415359Barthuly AM, Bohannon RW, Gorack W. Gait speed is a responsive measure of physical performance for patients undergoing short-term rehabilitation. Gait Posture. 2012 May;36(1):61-4. doi: 10.1016/j.gaitpost.2012.01.002. Epub 2012 Mar 8.
PubMed 22406292
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Reliability and Validity of 4-meter and 10-meter Walking Test for Measurements of Gait Speed and Their Correlation With 5-repetition Sit-to-stand Test in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT04919772
- Acronym / sponsor ID
- 4-meter walking test
- Keywords
- walking speed, gait, sit-to-stand, reliability, validity, correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Jun 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 4-meter walk test and 10-meter walk test is currently applied to assess gait speed.These tools are frequently used in clinical trials and were also shown to be reliable measurement methods. There are ocassions where it is not possible to have a long corridor to measure gait speed. It is necessary to have a tool to evaluate gait speed in a small space as 4-meter walk test.
Detailed description
Walking speed is an important aspect of gait and is commonly used as an objective measure of functional mobility in both clinical and research settings. The majority who have suffered a stroke tend to have gait disturbances. Regaining locomotor ability is one of the primary goals in stroke rehabilitation, and it is most commonly measured using changes in self-selected walking speed. Although many of them can walk independently, they do not do so with enough speed and endurance to allow them to perform their activities of daily living prior to stroke. Not only is self-selected walking speed simple, cost effective, reliable, valid, sensitive, and specific, but it is also highly related to the severity of impairment and predicts functional walking status. It is recommended as a "vital sign" of health. Improvements in walking speed of 0.1 m/s or more have been shown to be a predictor of good health. However, decreased walking speed has been related to worse health outcomes and frailty in older people.
The 4-meter walk test (4 MWT) and 10-meter walk test (10 MWT) is currently applied using various timing protocols and distance covered that may affect data interpretation with a standard value, and comparisons among the studies. There are two protocols to measure walking speed, static and flying start. A static start (i.e., record the time used to cover a total walkway or from the start to stop walking) or a flying start (i.e., measured the time while walking in the middle of the walkway).
The aim of this study is to investigate the test-retest reliability of the 4 MWT and 10 MWT and their correlation with 5-repetition sit-to-stand in chronic stroke survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors | – | Other: AssessmentChronic stroke, generally speaking chronic stroke refers to the period of recovery that takes place at least six months after the initial stroke event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors in chronic phase > 6 months
Key inclusion criteria (4 listed)
- All study participants are clinically diagnosed with stroke
- Adult participants, defined as >18 years of age
- Have preserved cognitive ability: Achieve a score equal to or greater than 25 points on the Montreal Cognitive Assessment test.
- Have the ability to walk on a flat surface of at least 20 meters, with or without aid.
Key exclusion criteria (5 listed)
- A history of lower extremities injury or surgery
- A history of botulinum injection within 3 months
- A history of inflammatory arthritis
- A history of inflammatory myopathy or peripheral nervous disease
- A history of other neurological disease as a Parkinson, spinal cord etc.
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 |
|---|---|---|
| AssessmentAlso: EvaluationThe participants walk 4-meter and 10-meter and 5-repetition sit-to-stand twice. | Other | Stroke survivors |
Primary outcome
Reliability of 4-meter walking test
Time frame: Baseline
Reliability is the overall consistency of a measure.
Reliability of 4-meter walking test
Time frame: 1 hour later from baseline
Reliability is the overall consistency of a measure.
Validity of 4-meter walking test
Time frame: Baseline
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Validity of 4-meter walking test
Time frame: 1 hour later from baseline
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Reliability of 10-meter walking test
Time frame: Baseline
Reliability is the overall consistency of a measure.
Reliability of 10-meter walking test
Time frame: 1 hour later from baseline
Reliability is the overall consistency of a measure.
Validity of 10-meter walking test
Time frame: Baseline
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
Validity of 10-meter walking test
Time frame: 1 hour later from baseline
Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
2 secondary outcomes
Correlation of 5-repetition sit-to-stand with 4-meter walking test
Time frame: Baseline
Correlation of 5-repetition sit-to-stand with 10-meter walking test
Time frame: Baseline
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 27 Jul 2022.
- Background: PubMed 19856632Bohannon RW. Measurement of gait speed of older adults is feasible and informative in a home-care setting. J Geriatr Phys Ther. 2009;32(1):22-3. doi: 10.1519/00139143-200932010-00005.
- Background: PubMed 23983271Karpman C, Lebrasseur NK, Depew ZS, Novotny PJ, Benzo RP. Measuring gait speed in the out-patient clinic: methodology and feasibility. Respir Care. 2014 Apr;59(4):531-7. doi: 10.4187/respcare.02688. Epub 2013 Aug 27.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Results publication: PubMed 10499938Richards CL, Malouin F, Dean C. Gait in stroke: assessment and rehabilitation. Clin Geriatr Med. 1999 Nov;15(4):833-55.
- Results publication: PubMed 17939776Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.
- Results publication: PubMed 7811170Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
- Results publication: PubMed 15370761Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
- Results publication: PubMed 9021278Parker CJ, Gladman JR, Drummond AE. The role of leisure in stroke rehabilitation. Disabil Rehabil. 1997 Jan;19(1):1-5. doi: 10.3109/09638289709166438.
- Results publication: PubMed 10811152Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
- Results publication: PubMed 31449180Awad L, Reisman D, Binder-Macleod S. Distance-Induced Changes in Walking Speed After Stroke: Relationship to Community Walking Activity. J Neurol Phys Ther. 2019 Oct;43(4):220-223. doi: 10.1097/NPT.0000000000000293.
- Results publication: PubMed 16282564Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005 Oct;60(10):1304-9. doi: 10.1093/gerona/60.10.1304.
- Results publication: PubMed 11944746Feld JA, Rabadi MH, Blau AD, Jordan BD. Berg balance scale and outcome measures in acquired brain injury. Neurorehabil Neural Repair. 2001;15(3):239-44. doi: 10.1177/154596830101500312.
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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.
Laura García-Rueda, MsC study director
Universitat Internacional de Catalunya
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 Stroke and Gait, Hemiplegic, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 4 inclusion and 5 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 27 Jul 2022. 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 Spain. 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?
Reliability of 4-meter walking test (time frame: Baseline). The study lists 8 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 NCT04919772, which also lists 25 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 27 Jul 2022.