Walk-test: 6 and 10 Meters WalkTest Acceleration Distance in Stroke Survivors

Sponsor
Universitat Internacional de Catalunya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05679011
Collaborator
(none)
10
1
20
0.5

Study Details

Study Description

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 best distance required to accelerate and decelerate and the optimal distance to time walking speed in people in the chronic phase of stroke.

Objectives: The main objective is to analyze whether the 6-meter walk test (6-MeWT) with one meter for acceleration and one for deceleration is optimal as well as 2 meters for acceleration and deceleration in the 10-meter walk test (10-MWT) both at maximum and comfortable or usual speed for patients who have suffered a stroke in the chronic phase (> 6 months).

The secondary objective is to evaluate whether the 10-meter walk test (10-MWT) with two meters for acceleration and deceleration is comparable to the 6-MeWT with one meter for acceleration and one meter for deceleration for a correct measurement of gait in patients who have suffered a stroke in chronic phase (> 6 months).

Methods: A cross-sectional observational study will be performed. The results of the 6-MeWT with a one-meter zone for acceleration and a one-meter zone for deceleration will be compared with the 10-meter gait test (10-MWT) with 2 meters for acceleration and 2 meters for deceleration. The patient will have 8 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 will be 3 repetitions for each of the tests. The patient will be randomized to start with either the 6 MeWT or the 10 MWT test. All tests will be performed on the same day. One researcher will perform the timing measurements, another will count the number of steps and another will record the signal sent by the cameras, which record the movement of the sensors.

Discussion: This study will shed light on what is the optimal distance required for acceleration and deceleration in the 6 MeWT and 10 MWT walking tests and whether the two tests are comparable.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 6 and 10 meters walking test 6-MeWT

Detailed Description

Stroke is a worldwide health problem and in the last two decades, the number of survivors has increased. One third of them present an inability to walk in the community and the others present different gait disturbances such as slow speed and lack of stamina to allow them to return to pre-stroke activity levels.

Returning home and community ambulation is a primary rehabilitation goal for many stroke survivors. Ambulation ability is commonly correlated with gait speed. It is commonly used as an objective measure of functional mobility. and is strongly associated with fall risk, quality of life, and gait independence. In addition, it has been shown to have the potential to predict an individual's future functional impairment and long-term survival. It is recommended to use gait speed as a "vital sign" of health. Improvements of 0.1 meters/second or more have been found to predict good health, whereas decreased walking speed has been associated with worse health outcomes. Ambulation ability predicted by walking speed is a reliable method for classifying the functional status of stroke survivors.

To date, the 10-meter comfort walk test (10-MWT) is a measure that has demonstrated excellent reliability and construct validity throughout the post-stroke rehabilitation process and is sensitive to change in that population.

But different researchers disagree on how to run the test. Some perform the test in a 14-meter corridor. A disadvantage may be that an ambulatory or home medical practice setting may have limited space and/or terrain with different obstacles, such as furniture, to walk on. Others perform it in 10 meters and time the 6 meters, leaving 2 meters to accelerate and another 2 meters to decelerate. To authors' knowledge, have not found any study in a gait laboratory assessing whether this distance is correct for accelerating and decelerating in these individuals.

An alternative option to the 10-MWT could be the 6-MeWT, which is included in the Short Physical Performance Battery (SPPB). SPPB is one of the most widely used tools in the investigation of elderly people and as a predictor of functional capacity after stroke. This test consists of three tests: balance, 4-MWT (no zone for acceleration/deceleration) and 5 times sitting and standing. The 4-MWT is increasingly used as an independent measure and is an established marker of exercise capacity in the elderly.

To authors' knowledge there are four studies correlating 4-MWT with 10-MWT: three studies in elderly population only was evaluated in women, one in lower extremity surgery, and one in pulmonary pathology. Some authors used 5 meters of acceleration and deceleration for the 10-MWT test, i.e. they needed a 20-meter corridor and 2 meters for the 4-MWT they needed an 8-meter corridor. Other author did not use zones for acceleration and deceleration. Another used 2 meters of acceleration and deceleration for the 10-MWT and for the 4-MWT. Other author used 2 meters of acceleration and deceleration for the 10-MWT and 3 meters of acceleration and deceleration for the 4-MWT in healthy individuals, with various pathologies and in elderly people.

In the scientific literature there is no common agreement on how to name the gait tests. Some call the test by the meters timed and others call it by the meters that are necessary to perform the test, regardless of the acceleration and deceleration zone. The authors have decided to name the tests by the meters necessary to carry out the test. Therefore the 6-MeWT test will be 6 meters in total, which are needed to perform the test and 4 meters are timed and 10-MWT also the meters needed regardless of the acceleration and deceleration zone, therefore 6 meters are timed.

To authors' knowledge there are no studies using 1 meter for acceleration and deceleration in the 6-MeWT test in adults in the chronic phase of stroke (≥ 6 months).

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Comparison of Acceleration and Gait Speed Between the 6 and 10 Meter Walking Tests in Chronic Stroke Survivors. Cross-sectional Observational Pilot Study
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Acceleration distance [through study completion, an average of 1 year]

    Distance time that an individual needs to reach their average gait speed

Secondary Outcome Measures

  1. Gait speed [through study completion, an average of 1 year]

    Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitat Internacional de Catalunya Sant Cugat del Valles Barcelona Spain 08195

Sponsors and Collaborators

  • Universitat Internacional de Catalunya

Investigators

  • Principal Investigator: Rosa Cabanas-Valdés, PhD, Universitat Internacional de Catalunya

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rosa Cabanas Valdés, Principal investigator, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT05679011
Other Study ID Numbers:
  • FIS-2022-12
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rosa Cabanas Valdés, Principal investigator, Universitat Internacional de Catalunya
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023