Spastic Cerebral Palsy Clinical Trial
Official title:
Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
NCT number | NCT06355869 |
Other study ID # | s65337 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 17, 2021 |
Est. completion date | May 31, 2023 |
Verified date | April 2024 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: - Gross Motor Function Classification System (GMFCS) level I - III - CP (bilateral & unilateral) - Age: 6 - 17 years - Prescribed AFO by the medical team (as part of the standard care) Exclusion Criteria: - Severe contractures or spasticity, which makes it impossible to wear a conventional AFO - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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= v((?¦?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) | |
Primary | 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) | |
Primary | 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= v((?¦?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] |
A period of 1-14 days is foreseen between the two measurements (3DGA) | |
Primary | 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 v(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) |
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