Clinical trial NCT06355869: Repeatability of Gait Deviations in Children With Cerebral Palsy
Official title: Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spastic Cerebral Palsy
Keywords: Cerebral Palsy
Rehabilitation
Gait analysis
Variability
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The standard error of measurement (SEM) of the continuous kinematic gait waveforms
timeFrame: A period of 1-14 days is foreseen between the two measurements (3DGA)
measure: The intra-class correlation (ICC) of the gait indices
timeFrame: A period of 1-14 days is foreseen between the two measurements (3DGA)
measure: The standard error of measurement (SEM) of the continuous kinetic gait waveforms
timeFrame: A period of 1-14 days is foreseen between the two measurements (3DGA)
measure: The standard error of measurement (SEM) of the gait indices
timeFrame: A period of 1-14 days is foreseen between the two measurements (3DGA)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Department of Rehabilitation Sciences, KU Leuven, Belgium
name: Kaat Desloovere, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.