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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04919772
Other study ID # 4-meter walking test
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 30, 2021

Study information

Verified date July 2022
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. It is necessary to have a tool to evaluate gait speed in a small space as 4-meter walk test.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 30, 2021
Est. primary completion date December 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Assessment
The participants walk 4-meter and 10-meter and 5-repetition sit-to-stand twice.

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1080/10749357.2019.1691 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

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. Epub 2007 Oct 3. — View Citation

Jørgensen 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Parker CJ, Gladman JR, Drummond AE. The role of leisure in stroke rehabilitation. Disabil Rehabil. 1997 Jan;19(1):1-5. Review. — View Citation

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.0b — View Citation

Richards CL, Malouin F, Dean C. Gait in stroke: assessment and rehabilitation. Clin Geriatr Med. 1999 Nov;15(4):833-55. Review. — View Citation

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. — View Citation

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. — View Citation

Wade DT, Hewer RL. Functional abilities after stroke: measurement, natural history and prognosis. J Neurol Neurosurg Psychiatry. 1987 Feb;50(2):177-82. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability of 4-meter walking test Reliability is the overall consistency of a measure. Baseline
Primary Reliability of 4-meter walking test Reliability is the overall consistency of a measure. 1 hour later from baseline
Primary 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 Baseline
Primary 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 1 hour later from baseline
Primary Reliability of 10-meter walking test Reliability is the overall consistency of a measure. Baseline
Primary Reliability of 10-meter walking test Reliability is the overall consistency of a measure. 1 hour later from baseline
Primary 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 Baseline
Primary 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 1 hour later from baseline
Secondary 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. Baseline
Secondary 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. Baseline
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