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Interlaboratory Reliability of 3D Gait Analysis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05530213
Enrollment
30
Registered
2022-09-07
Start date
2022-10-01
Completion date
2024-09-01
Last updated
2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Analysis, Reproducibility

Keywords

Norm database, Reliability, 3D gait analysis

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.

Interventions

DEVICE3D gait analysis on the GRAIL

3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical)

The subject's body weight and height will be assessed

Sponsors

Hasselt University
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Data analysis will be carried out by investigators who are blind to the location of where the data was collected.

Intervention model description

A single group of participants will be tested in 3 locations. Their results across the three locations will be compared

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
3D lower limb kinematics (angles °)Single point of assessment in one dayMarker 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 dayForce plate data is collected during the 3D gait analysis and hip, knee and ankle kinetics are calculated while walking at 3 different gait velocities.

Countries

Belgium, Netherlands

Contacts

Primary ContactLynn Bar-On, PhD
lynn.baron@ugent.be+32 9 332 26 32
Backup ContactAnke Van Bladel, PhD
Anke.VanBladel@UGent.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026