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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04288960
• Other study ID #: Wright_Validity_GWalk
• Status: Suspended
• Start date: September 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: University of Winchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

Intervention

Device:
• Gwalk accelerometer walking trials
No intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device

Locations

Country	Name	City	State
United Kingdom	University of Winchester	Winchester	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Winchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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). pii: jsr.2018-0295. doi: 10.1123/jsr.2018-0295. — View Citation

Outcome

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