NCT06355869|Completed
Repeatability of Gait Deviations in Children With Cerebral Palsy
Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
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Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
Sponsor study identifier
observational
10
1 country
1
Study Start
August 17, 2021
Actual (reported)Primary Completion
May 31, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2021
Actual (reported)May 31, 2023
Actual (reported)May 31, 2023
Actual (reported)April 2, 2024
Actual (reported)April 10, 2024
Actual (reported)The standard error of measurement (SEM) of the continuous kinematic gait waveforms
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations\^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinematic continuous waveforms in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. \[4\]
A period of 1-14 days is foreseen between the two measurements (3DGA)
The intra-class correlation (ICC) of the gait indices
The inter-trial and -session variability was defined by the use of the intra-class correlation coefficient (ICC; 2,1) (two-way random model with absolute agreement), along with the 95% confidence interval of the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion).
A period of 1-14 days is foreseen between the two measurements (3DGA)
The standard error of measurement (SEM) of the continuous kinetic gait waveforms
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations\^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinetic continuous waveforms (i.e., moments \& powers) in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. \[4\]
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.
Our TD-database of the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven was used for the calculation of the gait indices.
An observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
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.
Kaat Desloovere, prof. dr.
Department of Rehabilitation Sciences, KU Leuven, Belgium
10 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2024
First Posted
April 10, 2024
Study Start
August 17, 2021
Actual (reported)3D-Microscopic Muscle Architecture in Cerebral Palsy
A period of 1-14 days is foreseen between the two measurements (3DGA)
The standard error of measurement (SEM) of the gait indices
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= SD x √(1-ICC), where SD is the standard deviation of the grand mean (mean of session 1 and session 2) from all participants. The SEM was calculated for the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement, which makes the use of SEM particularly clinically relevant.
A period of 1-14 days is foreseen between the two measurements (3DGA)
Contact the study team to confirm eligibility.
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.
Primary Completion
May 31, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Last Updated
April 15, 2024
Record last verified: 2024-04
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