Repeatability of Gait Deviations in Children With Cerebral Palsy
NCT ID: NCT06355869
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2021-08-17
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gait Classification in Children With Cerebral Palsy, a Reliability Study
NCT06448065
Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
NCT04559776
Loading Gait in Spatic Cerebral Palsy
NCT02010736
Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery
NCT06505499
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
NCT00338858
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. However, gait variability can arise from intrinsic (i.e., caused by the person's natural gait variability) and extrinsic (i.e., methodological sources, such as marker placement errors) factors and may vary between walking conditions. Follow-up and/or pre- and post-intervention 3DGA's are used to determine the treatment for these children with CP. So, it is important to know when differences between 3DGA's can be seen as 'true differences' or when the difference can be explained by intrinsic/extrinsic gait variability.
The purpose of the current study is to quantify the repeatability of gait in children with CP. Therefore, the repeatability between two 3DGA's that are performed at the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven will be assessed, following the standard 3DGA procedure that is applied at CMAL for routine clinical follow-up.
On the first test day, subjects will first receive a standard clinical examination preceding the clinical overground 3DGA that is planned as a routine clinical follow-up at the CMAL, extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute.
On the second test day, a repeated 3DGA overground and on the treadmill will be performed by the same clinician. This involved clinical assessor is well-trained to perform 3GDA in children with CP.
Between the measurements, a period from 1 - 14 days is foreseen. The combinations of repeated gait trials per test day, and the repeated test days, with involvement of only one assessor, facilitates the distinction between intrinsic and extrinsic variability.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ambulatory children with spastic CP
Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.
repeated 3D gait-analysis
An observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements.
TD children
Our TD-database of the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven was used for the calculation of the gait indices.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
repeated 3D gait-analysis
An observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* CP (bilateral \& unilateral)
* Age: 6 - 17 years
* Prescribed AFO by the medical team (as part of the standard care)
Exclusion Criteria
* Cognitive or visual impairment that hinder them to understand instructions
* Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
* Presence of ataxia or dystonia
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kaat Desloovere
Prof. Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kaat Desloovere, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation Sciences, KU Leuven, Belgium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
Morris C, Bowers R, Ross K, Stevens P, Phillips D. Orthotic management of cerebral palsy: recommendations from a consensus conference. NeuroRehabilitation. 2011;28(1):37-46. doi: 10.3233/NRE-2011-0630.
Schwartz MH, Trost JP, Wervey RA. Measurement and management of errors in quantitative gait data. Gait Posture. 2004 Oct;20(2):196-203. doi: 10.1016/j.gaitpost.2003.09.011.
Everaert L, Dewit T, Huenaerts C, Van Campenhout A, Labey L, Desloovere K. Repeatability of gait of children with spastic cerebral palsy in different walking conditions. J Biomech. 2024 Nov;176:112301. doi: 10.1016/j.jbiomech.2024.112301. Epub 2024 Aug 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
s65337
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.