NCT04288960

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 26, 2022

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

February 25, 2020

Last Update Submit

May 19, 2022

Conditions

StrokeGait, Hemiplegic

Keywords

strokevaliditygait

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

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

Interventions

Gwalk accelerometer walking trialsDEVICE

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

Chronic Stroke

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \<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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Winchester

Winchester, Hampshire, SO224NR, United Kingdom

Location

Related 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):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.

    PMID: 30747572BACKGROUND

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy Wright, MSc

    University of Winchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

September 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 26, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

There is no plan to share this information with other researchers

Locations

GB(1)