Interlaboratory Reliability of 3D Gait Analysis

NCT ID: NCT05530213

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-09-01

Brief Summary

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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

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Conditions

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Gait Analysis Reproducibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

3D gait analysis on the GRAIL

Intervention Type DEVICE

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

Weight and height

Intervention Type OTHER

The subject's body weight and height will be assessed

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.

Group Type EXPERIMENTAL

3D gait analysis on the GRAIL

Intervention Type DEVICE

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

Weight and height

Intervention Type OTHER

The subject's body weight and height will be assessed

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.

Group Type EXPERIMENTAL

3D gait analysis on the GRAIL

Intervention Type DEVICE

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

Weight and height

Intervention Type OTHER

The subject's body weight and height will be assessed

Interventions

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3D gait analysis on the GRAIL

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

Intervention Type DEVICE

Weight and height

The subject's body weight and height will be assessed

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasselt University

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynn Bar-On, PhD

Role: PRINCIPAL_INVESTIGATOR

UGent

Locations

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University Hasselt

Hasselt, , Belgium

Site Status RECRUITING

Maastricht University

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Belgium Netherlands

Central Contacts

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Lynn Bar-On, PhD

Role: CONTACT

+32 9 332 26 32

Anke Van Bladel, PhD

Role: CONTACT

Facility Contacts

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Pieter Meyns, PhD

Role: primary

Kenneth Meijer, PhD

Role: primary

Other Identifiers

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ONZ-2022-0248

Identifier Type: -

Identifier Source: org_study_id

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