Interlaboratory Reliability of 3D Gait Analysis

Gait Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530213
• Other study ID #: ONZ-2022-0248
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: University Ghent
• Contact: Lynn Bar-On, PhD
• Phone: +32 9 332 26 32
• Email: lynn.baron[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Analysis
• Reproducibility

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hasselt	Hasselt
Netherlands	Maastricht University	Maastricht

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	Hasselt University, Maastricht University

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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