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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05679011
Other study ID # Gait speed optimal distance
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 23, 2023
Est. completion date December 1, 2025

Study information

Verified date January 2024
Source Universitat Internacional de Catalunya
Contact Carlos-Antonio Zárate-Tejero, PhD
Phone +34935042000
Email czarate@uic.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Gait disorder is a common clinical problem after stroke and is among the prevalent physical limitations contributing to stroke-related disability that impacts performance of activities of daily(1). Gait disturbances in patients with stroke are caused by weakness (paresis or paralysis), abnormal tone in the limbs or trunk, or by disturbances in the sensory-motor system or central control mechanisms.(2) Therefore, gait recovery is a major objective in the rehabilitation program in stroke survivors.(3) Walking speed is considered to be the sixth vital sign (4). Clinical practice guidelines worldwide recommend using reliable and valid tools to assess walking in stroke rehabilitation.(5,6) The 10 meter walk test at comfortable speed is widely recommended to reflect a walking speed. (7) However, there are many different distances to accelerate and decelerate.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. 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


Related Conditions & MeSH terms


Intervention

Other:
4 and 6 meters walking test
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.

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat del Valles Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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

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. — 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. doi: 10.1586/14737175.7.10.1417. — 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. doi: 10.1177/154596830101500312. — 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. doi: 10.1080/16501960410016776. — 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 short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. — View Citation

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. — 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. doi: 10.1093/gerona/60.10.1304. — View Citation

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. — View Citation

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. — View Citation

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

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. Erratum In: J Neurol Phys Ther. 2023 Jan 1;47(1):63. — 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

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Gait speed for 6mWT Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. 15 minutes
Secondary Gait speed for 4mWT Gait speed is the time one takes to walk a specified distance on level surfaces over a 15 minutes
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