Interlaboratory Reliability of 3D Gait Analysis
1 other identifier
interventional
30
2 countries
2
Brief Summary
The purpose of this study is to determine the interlaboratory reliability of 3D gait analysis performed on healthy subjects on an instrumented treadmill in three different laboratories. This will allow us to evaluate whether the pooling of control data is feasible in future studies. This will support our ambitions to enter into future collaborations to conduct studies with larger samples. Moreover, this way we will know if we can share patient data in the future so that patients can be specifically referred to a lab with expertise on a particular evaluation, e.g. the lab in Maastricht has expertise on perturbations, UZ Gent has expertise on full-body measurements and UHasselt has expertise on balance. During this study approximately 30 healthy subjects will be recruited (10 from each center) from the staff and students at each center. These subjects are own staff and students of the 3 centers. Each subject will undergo a 3D gait analysis at each center (at UZGent, UHasselt and UMaastricht). Therefore, each subject will be evaluated 3 times. The time between each evaluations will be a maximum of one week. The evaluations will be performed as per standard procedure in each lab. However, a standardized model (HBM2 lower limb), an agreed walking velocity (0.9 m/s, 1.0 m/s, 1.1 m/s) and an agreed duration per recording (3 min) will be used. The same software will be used to process the collected data. 3D kinematics and kinetic time-series data of the lower limbs will be extracted as outcome data. Absolute reliability indices will be calculated in the following way: First, the standard deviation (SD) of time-series data across different gait cycles will be calculated per participant per center. The SD values across different centers per participant will then be averaged. Finally, the SD values across different participants will form the inter-laboratory reliability indices. In addition, we will use statistical parametric mapping (Anova repeated measures) to compare the full time-series data of each outcome parameter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Typical duration for not_applicable
2 active sites
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
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedAugust 25, 2023
August 1, 2023
1.9 years
August 30, 2022
August 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
3D lower limb kinematics (angles °)
Marker trajectory data is collected during the 3D gait analysis and lower limb kinematics are calculated in post-processing. Pelvis, hip, knee and ankle angles will be assessed during walking at 3 different gait velocities
Single point of assessment in one day
3D lower limb kinetics (Nm/kg)
Force plate data is collected during the 3D gait analysis and hip, knee and ankle kinetics are calculated while walking at 3 different gait velocities.
Single point of assessment in one day
Study Arms (3)
Healthy adults UZ Gent
EXPERIMENTALA group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UZ Gent within a week of the 3D gait analysis at UHasselt and/or UMaastricht.
Healthy adults UHasselt
EXPERIMENTALThe same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UMaastricht.
Healthy adults UMaastricht
EXPERIMENTALThe same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UZGent.
Interventions
3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical)
The subject's body weight and height will be assessed
Eligibility Criteria
You may qualify if:
- healthy subjects aged 18-65 years old
You may not qualify if:
- Individuals cannot participate if:
- They suffer from a neurological disorder.
- They experience balance problems.
- They have had surgical procedures on the legs in the past.
- They are taking medication that may affect gait and balance. They experience leg or back pain at the time of test taking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Hasselt Universitycollaborator
- Maastricht Universitycollaborator
Study Sites (2)
University Hasselt
Hasselt, Belgium
Maastricht University
Maastricht, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Bar-On, PhD
UGent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data analysis will be carried out by investigators who are blind to the location of where the data was collected.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 7, 2022
Study Start
October 1, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
August 25, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
According to the ethics agreements, an IPD data sharing plan document is available at each institute.