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

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.

Study Overview

• Status: Suspended
• Conditions: Stroke; Gait, Hemiplegic
• Intervention / Treatment: Device: Gwalk accelerometer walking trials

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Winchester, Hampshire, United Kingdom, SO224NR
      • University of Winchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Stroke; 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.	Device: Gwalk accelerometer walking trials; No intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Winchester
• Investigators: Principal Investigator: Amy Wright, MSc, University of Winchester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: stroke; gait; validity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Gait Disorders, Neurologic
• Other Study ID Numbers: Wright_Validity_GWalk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share this information with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No