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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04288960
Other study ID # Wright_Validity_GWalk
Secondary ID
Status Suspended
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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