Gait AnalysisNCT05530213
Interlaboratory Reliability of 3D Gait Analysis
A study testing 3D gait analysis on the GRAIL and Weight and height in people with Gait Analysis and Reproducibility, run by University Ghent at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Analysis, Reproducibility
- What is being tested?
- 3D gait analysis on the GRAIL and Weight and height
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects aged 18-65 years old
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
Anke Van Bladel, PhD contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hasselt
Hasselt
Pieter Meyns, PhD, pieter.meyns@uhasselt.be
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
Kenneth Meijer, PhD, kenneth.meijer@maastrichtuniversity.nl
About this study
Official title: 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.
- Conditions
- Gait Analysis, Reproducibility
- Being tested
- 3D gait analysis on the GRAIL, Weight and height
- Keywords
- Norm database, Reliability, 3D gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D gait analysis on the GRAILDevice
3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical)
Weight and heightOther
The subject's body weight and height will be assessed
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults UZ Gent | Experimental | 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. Receives: Device: 3D gait analysis on the GRAIL; Other: Weight and height |
| Healthy adults UHasselt | Experimental | 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. Receives: Device: 3D gait analysis on the GRAIL; Other: Weight and height |
| Healthy adults UMaastricht | Experimental | 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. Receives: Device: 3D gait analysis on the GRAIL; Other: Weight and height |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Single point of assessment in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A single group of participants will be tested in 3 locations. Their results across the three locations will be compared
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Lynn Bar-On, PhD, Principal investigator, UGent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530213
- Sponsor's protocol ID
- ONZ-2022-0248
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the ethics agreements, an IPD data sharing plan document is available at each institute.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interlaboratory Reliability of 3D Gait Analysis Performed on an Instrumented Treadmill.
- ClinicalTrials.gov ID
- NCT05530213
- Acronym / sponsor ID
- ONZ-2022-0248
- Conditions
- Gait Analysis, Reproducibility
- Keywords
- Norm database, Reliability, 3D gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Hasselt University, Maastricht University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A single group of participants will be tested in 3 locations. Their results across the three locations will be compared
| Arm | Type | Receives |
|---|---|---|
| Healthy adults UZ Gent | Experimental | Device: 3D gait analysis on the GRAIL, Other: Weight and heightA 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 | Experimental | Device: 3D gait analysis on the GRAIL, Other: Weight and heightThe 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 UMaastricht | Experimental | Device: 3D gait analysis on the GRAIL, Other: Weight and heightThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects aged 18-65 years old
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D gait analysis on the GRAIL3D gait anlysis performed on an instrumented treadmill (GRAIL, Motek Medical) | Device | Healthy adults UHasselt, Healthy adults UMaastricht, Healthy adults UZ Gent |
| Weight and heightThe subject's body weight and height will be assessed | Other | Healthy adults UHasselt, Healthy adults UMaastricht, Healthy adults UZ Gent |
Primary outcome
3D lower limb kinematics (angles °)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Yes. According to the ethics agreements, an IPD data sharing plan document is available at each institute.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anke Van Bladel, PhD contact
Lynn Bar-On, PhD principal investigator
UGent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D gait analysis on the GRAIL and Weight and height in people with Gait Analysis and Reproducibility, run by University Ghent at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynn Bar-On, PhD (+32 9 332 26 32, lynn.baron@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D lower limb kinematics (angles °) (time frame: Single point of assessment in one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.