Clinical trial NCT04288960: Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke
Official title: Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stroke
Gait, Hemiplegic
Keywords: stroke
validity
gait
Lead sponsor: University of Winchester
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic stroke (\<3month post stroke) will be recruited from a neuro-physiotherapy practice, community-based stroke support groups and community exercise programme. All participants would have been diagnosed with stroke by a specialist neurologist/stroke consultant from a UK National Health Service (NHS) Foundation Trust, and have undertaken normal inpatient and outpatient rehabilitation in accordance with NICE guidelines (National Institute of Health and CARE

Brief summary: The aim of this study is to validate the G-walk for several gait parameters, tested against a gold standard three dimensional camera system. This research will inform researchers and practitioners as to whether the G-Walk is a suitable and valid tool to easily assess walking ability in people with chronic stroke.

Detailed description: Twenty chronic stroke survivors will be recruited for this study from an independent neuro-physiotherapy practice and community exercise programme.Gait analysis will be used to look at several gait parameters through the use of a three-dimensional visual analysis system based in our Biomechanics Lab at the University of Winchester. Participants will attend testing one testing session of approximately 1 hour. During this testing session functional measures and walking trials will be assessed. Participants will first be asked to complete a set of simple movements that will contribute towards Fugl Meyer questionnaire. Twenty eight reflective markers will then be attached to specified joints and segments of the body, such as the thigh, with double sided sticky tape to allow for data collection through the camera system to collect kinematic data. The belt mounted accelerometer (G-Walk) will be positioned around the waist over the L5 vertebrae. Participants will be asked to perform 6 walking trials of 10m to collect 3D kinematic and accelerometer gait data.

Eligibility criteria: Inclusion Criteria:

* \<3 months post stroke
* Lower limb impairment
* Able to stand and step independently
* Functional ambulation classifications (FAC) of 2-5
* Modified Rankin Scale (MRS) of 1-3
* Cognitively aware to undertake the testing session

Exclusion Criteria:

* Unresolved deep vein thrombosis
* unstable cardiovascular conditions
* open wounds
* active drug resistant infection
* recent fractures of involved limb
* peripheral arterial disease
* incontinence
* severe osteoporosis
* non-weight bearing.

Primary outcomes:
measure: Speed
timeFrame: 60 minutes
measure: Cadence
timeFrame: 60 minutes
measure: Stride Length
timeFrame: 60 minutes
measure: Swing phase duration
timeFrame: 60 minutes
measure: Stance phase duration
timeFrame: 60 minutes
measure: Gait cycle duration
timeFrame: 60 minutes
measure: Double support duration
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Winchester
country: United Kingdom
facility: University of Winchester
state: Hampshire
Study officials:
affiliation: University of Winchester
name: Amy Wright, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.