Interlaboratory Reliability of 3D Gait Analysis

Interlaboratory Reliability of 3D Gait Analysis Performed on an Instrumented Treadmill.

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.

Study Overview

• Status: Recruiting
• Conditions: Gait Analysis; Reproducibility
• Intervention / Treatment: Device: 3D gait analysis on the GRAIL; Other: Weight and height

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lynn Bar-On, PhD; Phone Number: +32 9 332 26 32; Email: lynn.baron@ugent.be
• Study Contact Backup: Name: Anke Van Bladel, PhD; Email: Anke.VanBladel@UGent.be

Study Locations

• Belgium
  • Hasselt, Belgium
    • Recruiting
    • University Hasselt
    • Contact: Pieter Meyns, PhD; Email: pieter.meyns@uhasselt.be
• Netherlands
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University
    • Contact: Kenneth Meijer, PhD; Email: kenneth.meijer@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy subjects aged 18-65 years old

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy adults UZ Gent; A 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.	Device: 3D gait analysis on the GRAIL; 3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical); Other: Weight and height; The subject's body weight and height will be assessed
Experimental: Healthy adults UHasselt; The 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.	Device: 3D gait analysis on the GRAIL; 3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical); Other: Weight and height; The subject's body weight and height will be assessed
Experimental: Healthy adults UMaastricht; The 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.	Device: 3D gait analysis on the GRAIL; 3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical); Other: Weight and height; The subject's body weight and height will be assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Hasselt University; Maastricht University
• Investigators: Principal Investigator: Lynn Bar-On, PhD, UGent

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Reliability; 3D gait analysis; Norm database
• Other Study ID Numbers: ONZ-2022-0248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the ethics agreements, an IPD data sharing plan document is available at each institute.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No