StrokeNCT04288960
Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke
An observational study of Stroke and Gait, Hemiplegic, run by University of Winchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Gwalk accelerometer walking trials
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- <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
Who cannot join
- Unresolved deep vein thrombosis
- unstable cardiovascular conditions
- open wounds
- active drug resistant infection
- recent fractures of involved limb
- peripheral arterial disease
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- incontinence
- severe osteoporosis
- non-weight bearing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Winchester
Winchester, Hampshire, SO224NR
About this study
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.
Read the 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.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Gwalk accelerometer walking trials
- Keywords
- stroke, validity, gait
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gwalk accelerometer walking trialsDevice
No intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Gwalk accelerometer walking trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed
How quickly a participant walks overground
Measured: 60 minutes
Cadence
Steps taken per minute
Measured: 60 minutes
Stride Length
The distance between strides
Measured: 60 minutes
Swing phase duration
Percentage of the gait cycle spent in swing phase
Measured: 60 minutes
Stance phase duration
Percentage of the gait cycle spent in stance phase
Measured: 60 minutes
Gait cycle duration
The time it takes to complete one gait cycle
Measured: 60 minutes
Double support duration
Percentage of the gait cycle spend with both feet on the ground (double support)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Sep 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Covid and access to participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Wright, MSc, Principal investigator, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288960
- Sponsor's protocol ID
- Wright_Validity_GWalk
- Status last verified
- Nov 2021
- First submitted
- 25 Feb 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share this information with other researchers
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.
PubMed 30747572
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04288960
- Acronym / sponsor ID
- Wright_Validity_GWalk
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- stroke, validity, gait
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Covid and access to participants
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Stroke | – | Device: Gwalk accelerometer walking trialsTwenty 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- <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
Key exclusion criteria (9 listed)
- Unresolved deep vein thrombosis
- unstable cardiovascular conditions
- open wounds
- active drug resistant infection
- recent fractures of involved limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gwalk accelerometer walking trialsNo intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device | Device | Chronic Stroke |
Primary outcome
Speed
Time frame: 60 minutes
How quickly a participant walks overground
Cadence
Time frame: 60 minutes
Steps taken per minute
Stride Length
Time frame: 60 minutes
The distance between strides
Swing phase duration
Time frame: 60 minutes
Percentage of the gait cycle spent in swing phase
Stance phase duration
Time frame: 60 minutes
Percentage of the gait cycle spent in stance phase
Gait cycle duration
Time frame: 60 minutes
The time it takes to complete one gait cycle
Double support duration
Time frame: 60 minutes
Percentage of the gait cycle spend with both feet on the ground (double support)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 30747572De 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.
- Individual participant dataSharing planned: No. There is no plan to share this information with other researchers
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Wright, MSc principal investigator
University of Winchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Gait, Hemiplegic, run by University of Winchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed (time frame: 60 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.