- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919772
Assessing the Reliability and Validity of 4-meter and 10-meter Walking Test
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08195
- Universitat Internacional de Catalunya
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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The participants walk 4-meter and 10-meter and 5-repetition sit-to-stand twice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reliability of 4-meter walking test
Time Frame: Baseline
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Reliability is the overall consistency of a measure.
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Baseline
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Reliability of 4-meter walking test
Time Frame: 1 hour later from baseline
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Reliability is the overall consistency of a measure.
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1 hour later from baseline
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Validity of 4-meter walking test
Time Frame: Baseline
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Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
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Baseline
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Validity of 4-meter walking test
Time Frame: 1 hour later from baseline
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Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
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1 hour later from baseline
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Reliability of 10-meter walking test
Time Frame: Baseline
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Reliability is the overall consistency of a measure.
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Baseline
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Reliability of 10-meter walking test
Time Frame: 1 hour later from baseline
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Reliability is the overall consistency of a measure.
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1 hour later from baseline
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Validity of 10-meter walking test
Time Frame: Baseline
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Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
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Baseline
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Validity of 10-meter walking test
Time Frame: 1 hour later from baseline
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Validity is the extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world
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1 hour later from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation of 5-repetition sit-to-stand with 4-meter walking test
Time Frame: Baseline
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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.
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Baseline
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Correlation of 5-repetition sit-to-stand with 10-meter walking test
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Investigators
- Study Director: Laura García-Rueda, MsC, Universitat Internacional de Catalunya
Publications and helpful links
General Publications
- Fried 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.
- Guralnik 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.
- Peters DM, Fritz SL, Krotish DE. Assessing the reliability and validity of a shorter walk test compared with the 10-Meter Walk Test for measurements of gait speed in healthy, older adults. J Geriatr Phys Ther. 2013 Jan-Mar;36(1):24-30. doi: 10.1519/JPT.0b013e318248e20d.
- Karpman 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.
- Eng 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.
- 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.
- Richards CL, Malouin F, Dean C. Gait in stroke: assessment and rehabilitation. Clin Geriatr Med. 1999 Nov;15(4):833-55.
- Jorgensen 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.
- Geyh 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.
- Parker CJ, Gladman JR, Drummond AE. The role of leisure in stroke rehabilitation. Disabil Rehabil. 1997 Jan;19(1):1-5. doi: 10.3109/09638289709166438.
- Awad 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.
- Montero-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.
- Feld 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.
- Taylor-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.
- Braden 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.
- Barthuly 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.
- Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007 Nov;55(11):1727-34. doi: 10.1111/j.1532-5415.2007.01413.x. Epub 2007 Oct 3.
- Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
- Graham JE, Ostir GV, Fisher SR, Ottenbacher KJ. Assessing walking speed in clinical research: a systematic review. J Eval Clin Pract. 2008 Aug;14(4):552-62. doi: 10.1111/j.1365-2753.2007.00917.x. Epub 2008 May 2.
- Amatachaya S PT, PhD, Kwanmongkolthong M PT, BSc, Thongjumroon A PT, BSc, Boonpew N PT, BSc, Amatachaya P ME, PhD, Saensook W PT PhD, Thaweewannakij T PT, PhD, Hunsawong T PT, PhD. Influence of timing protocols and distance covered on the outcomes of the 10-meter walk test. Physiother Theory Pract. 2020 Dec;36(12):1348-1353. doi: 10.1080/09593985.2019.1570577. Epub 2019 Feb 1.
- Cheng DK, Nelson M, Brooks D, Salbach NM. Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways. Top Stroke Rehabil. 2020 May;27(4):251-261. doi: 10.1080/10749357.2019.1691815. Epub 2019 Nov 21.
- Wade DT, Hewer RL. Functional abilities after stroke: measurement, natural history and prognosis. J Neurol Neurosurg Psychiatry. 1987 Feb;50(2):177-82. doi: 10.1136/jnnp.50.2.177.
- Unver B, Baris RH, Yuksel E, Cekmece S, Kalkan S, Karatosun V. Reliability of 4-meter and 10-meter walk tests after lower extremity surgery. Disabil Rehabil. 2017 Dec;39(25):2572-2576. doi: 10.1080/09638288.2016.1236153. Epub 2016 Oct 11.
- Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments. BMC Med Res Methodol. 2006 Jan 24;6:2. doi: 10.1186/1471-2288-6-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Brain Ischemia
- Stroke
- Brain Infarction
- Infarction
- Cerebral Infarction
- Cerebrovascular Disorders
- Gait Disorders, Neurologic
Other Study ID Numbers
- 4-meter walking test
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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