NCT04919772

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

May 23, 2021

Last Update Submit

July 26, 2022

Conditions

Keywords

walking speedgaitsit-to-standreliabilityvaliditycorrelation

Outcome Measures

Primary Outcomes (8)

  • Reliability of 4-meter walking test

    Reliability is the overall consistency of a measure.

    Baseline

  • Reliability of 4-meter walking test

    Reliability is the overall consistency of a measure.

    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

    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

    1 hour later from baseline

  • Reliability of 10-meter walking test

    Reliability is the overall consistency of a measure.

    Baseline

  • Reliability of 10-meter walking test

    Reliability is the overall consistency of a measure.

    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

    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

    1 hour later from baseline

Secondary Outcomes (2)

  • Correlation of 5-repetition sit-to-stand with 4-meter walking test

    Baseline

  • Correlation of 5-repetition sit-to-stand with 10-meter walking test

    Baseline

Study Arms (1)

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

Other: Assessment

Interventions

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

Also known as: Evaluation
Stroke survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke survivors in chronic phase \> 6 months

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, 08195, Spain

Location

Related Publications (25)

  • 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.

    PMID: 19856632BACKGROUND
  • 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.

    PMID: 23983271BACKGROUND
  • 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.

    PMID: 11253156BACKGROUND
  • Richards CL, Malouin F, Dean C. Gait in stroke: assessment and rehabilitation. Clin Geriatr Med. 1999 Nov;15(4):833-55.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Cabanas-Valdes R, Garcia-Rueda L, Salgueiro C, Perez-Bellmunt A, Rodriguez-Sanz J, Lopez-de-Celis C. Assessment of the 4-meter walk test test-retest reliability and concurrent validity and its correlation with the five sit-to-stand test in chronic ambulatory stroke survivors. Gait Posture. 2023 Mar;101:8-13. doi: 10.1016/j.gaitpost.2023.01.014. Epub 2023 Jan 20.

MeSH Terms

Conditions

StrokeGait Disorders, NeurologicCerebral InfarctionCerebrovascular Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Laura GarcĂ­a-Rueda, MsC

    Universitat Internacional de Catalunya

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2021

First Posted

June 9, 2021

Study Start

May 1, 2021

Primary Completion

December 29, 2021

Study Completion

December 30, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations