Interlaboratory Reliability of 3D Gait Analysis

Not Applicable

Recruiting

• Conditions: Gait Analysis; Reproducibility
• Interventions: Device: 3D gait analysis on the GRAIL; Other: Weight and height

• Registration Number: NCT05530213
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2022-10-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy adults UZ Gent	Weight and height	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.
Healthy adults UHasselt	Weight and height	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.
Healthy adults UZ Gent	3D gait analysis on the GRAIL	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.
Healthy adults UMaastricht	3D gait analysis on the GRAIL	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.
Healthy adults UMaastricht	Weight and height	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.
Healthy adults UHasselt	3D gait analysis on the GRAIL	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.

Primary Outcome Measures

Name	Time	Method
3D lower limb kinematics (angles °)	Single point of assessment in one day	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
3D lower limb kinetics (Nm/kg)	Single point of assessment in one day	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.

Trial Locations

Locations (2)

Maastricht University; 🇳🇱 Maastricht, Netherlands

University Hasselt; 🇧🇪 Hasselt, Belgium