Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke

Suspended

• Conditions: Gait, Hemiplegic; Stroke
• Interventions: Device: Gwalk accelerometer walking trials

• Registration Number: NCT04288960
• Lead Sponsor: University of Winchester

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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-28
• Status Verified: 2021-11
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26
• Study Start: 2022-09-01
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Stroke	Gwalk accelerometer walking trials	Twenty chronic stroke patients (\>3months post-stroke) will complete a one off session in a biomechanics lab. This session will include the Fugl Meyer Questionnaire and several walking trials along a flat, level 10m walkway. During this participants will wear a belt mounted accelerometer and small reflective markers on joints.

Primary Outcome Measures

Name	Time	Method
Cadence	60 minutes	Steps taken per minute
Stance phase duration	60 minutes	Percentage of the gait cycle spent in stance phase
Gait cycle duration	60 minutes	The time it takes to complete one gait cycle
Stride Length	60 minutes	The distance between strides
Speed	60 minutes	How quickly a participant walks overground
Swing phase duration	60 minutes	Percentage of the gait cycle spent in swing phase
Double support duration	60 minutes	Percentage of the gait cycle spend with both feet on the ground (double support)

Trial Locations

Locations (1)

University of Winchester; 🇬🇧 Winchester, Hampshire, United Kingdom