NCT05679011

Brief Summary

Introduction: Gait speed is currently used to predict the future functional status of the patient or to evaluate the improvements produced by different neurorehabilitation treatments. There is no common agreement among researchers and clinicians as to the optimal distance required to accelerate and decelerate in walking tests (4-meter and 6-meter timed) in people in the chronic phase of stroke. Objectives: The main objective is to analyze what is the optimal distance to accelerate and decelerate in the 4-meter walk test (4mWT) and 6-meter walk test (6mWT) at comfortable and fast speed with optical motion capture for chronic stroke survivors (\> 6 months). The secondary objective is to evaluate whether the mean gait speed taken by stopwatch is comparable to optical motion capture system Optitrack for the 4mWT and the 6mWT for a correct measurement of gait at comfortable and fast speed in in chronic stroke survivors. Methods: A cross-sectional observational study is performed. The walking speed is measured using the OptiTrack optical motion capture system consisting of 8 PrimeX 13 cameras and Motive 2.0 capture and analysis software (Natural Point Inc. Corvallis OR USA).The patient ware 8 markers sensors applied to different parts of the body. The two tests are performed first at a comfortable gait and second at the fastest gait that the patient can safely perform. There were 3 repetitions for each of the tests. The individuals are randomized to start with either the 6mWT or the 4mWT test. All tests are performed on the same day. Discussion: This study will shed light on what is the optimal distance required for acceleration and deceleration phases on the 6mWT and 4mWT walking tests at comfortable and fast speed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

December 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

December 22, 2022

Last Update Submit

March 25, 2025

Conditions

Keywords

gait speedcomfortable gait speedacceleration distancewalking test10mWT6mWTfast speed6 meters walk test4 meters walk testdeceleration distance

Outcome Measures

Primary Outcomes (4)

  • Acceleration/deceleration distance for 6mWT at comfortable speed

    Distance time that an individual needs to reach their average gait speed. Examinees are timed once the first foot passes the acceleration path; the time is stopped once the first foot enters the deceleration path.

    15 minutes

  • Acceleration/deceleration distance for 4mWT at comfortable speed

    Distance time that an individual needs to reach their average gait speed. Examinees are timed once the first foot passes the acceleration path; the time is stopped once the first foot enters the deceleration path.

    15 minutes

  • Acceleration/deceleration distance for 6mWT at fast speed

    Distance time that an individual needs to reach their average gait speed.Examinees are timed once the first foot passes the acceleration path; the time is stopped once the first foot enters the deceleration path.

    15 minutes

  • Acceleration/deceleration distance for 4mWT at fast speed

    Distance time that an individual needs to reach their average gait speed. Examinees are timed once the first foot passes the acceleration path; the time is stopped once the first foot enters the deceleration path.

    15 minutes

Secondary Outcomes (2)

  • Gait speed for 6mWT

    15 minutes

  • Gait speed for 4mWT

    15 minutes

Interventions

A 10-meter and other 6-meter flats pathways were identified. Two-meter are provided for the acceleration zone and two-meter for deceleration for 6-meter walk test. One meter to acceleration and another to deceleration for 4-meter walk test. The participants are randomly to perform 3-time to comfortable speed and 3-time faster speed for 4-meter and 6-meter.

Eligibility Criteria

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

Stroke survivors in chronic phase \> 6 months

You may qualify if:

  • Stroke survivors in chronic phase \> 6 months
  • 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 10 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

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (13)

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

    PMID: 10499938BACKGROUND
  • 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.

    PMID: 17939776BACKGROUND
  • 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.

    PMID: 7811170BACKGROUND
  • 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.

    PMID: 15370761BACKGROUND
  • 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.

    PMID: 9021278BACKGROUND
  • 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.

    PMID: 10811152BACKGROUND
  • 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.

    PMID: 31449180BACKGROUND
  • 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.

    PMID: 16282564BACKGROUND
  • 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.

    PMID: 11944746BACKGROUND
  • 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.

    PMID: 22119886BACKGROUND
  • 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.

    PMID: 36696822BACKGROUND
  • Ng SS, Au KK, Chan EL, Chan DO, Keung GM, Lee JK, Kwong PW, Tam EW, Fong SS. Effect of acceleration and deceleration distance on the walking speed of people with chronic stroke. J Rehabil Med. 2016 Oct 5;48(8):666-670. doi: 10.2340/16501977-2124.

    PMID: 27534654BACKGROUND
  • Salbach NM, MacKay-Lyons M, Howe JA, McDonald A, Solomon P, Bayley MT, McEwen S, Nelson M, Bulmer B, Lovasi GS. Assessment of Walking Speed and Distance Post-Stroke Increases After Providing a Theory-Based Toolkit. J Neurol Phys Ther. 2022 Oct 1;46(4):251-259. doi: 10.1097/NPT.0000000000000406. Epub 2022 Jun 7.

    PMID: 35671402BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rosa Cabanas-Valdés, PhD

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 10, 2023

Study Start

March 23, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations