Clinical trial NCT05679011: Analysis Acceleration/Deceleration Distance Gait Speed Tests in Stroke Survivors
Official title: Analysis of Optimal Acceleration/Deceleration Distance in Gait Speed Tests With Motion Capture System in Chronic Post-stroke. Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Chronic Stroke
Keywords: gait speed
comfortable gait speed
acceleration distance
walking test
10mWT
6mWT
fast speed
6 meters walk test
4 meters walk test
deceleration distance
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors in chronic phase \> 6 months

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceleration/deceleration distance for 6mWT at comfortable speed
timeFrame: 15 minutes
measure: Acceleration/deceleration distance for 4mWT at comfortable speed
timeFrame: 15 minutes
measure: Acceleration/deceleration distance for 6mWT at fast speed
timeFrame: 15 minutes
measure: Acceleration/deceleration distance for 4mWT at fast speed
timeFrame: 15 minutes
Secondary outcomes:
measure: Gait speed for 6mWT
timeFrame: 15 minutes
measure: Gait speed for 4mWT
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa Cabanas-Valdés, PhD
role: PRINCIPAL_INVESTIGATOR
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