Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355869
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-02
Brief Title:
Repeatability of Gait Deviations in Children With Cerebral Palsy
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie caused by the persons natural gait variability and extrinsic ie methodological sources such as marker placement errors factors and may vary between walking conditions Follow-up andor pre- and post-intervention 3DGAs are used to determine the treatment for these children with CP So it is important to know when differences between 3DGAs can be seen as true differences or when the difference can be explained by intrinsicextrinsic gait variability
The purpose of the current study is to quantify the repeatability of gait in children with CP Therefore the repeatability between two 3DGAs 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
Three-dimensional gait analysis 3DGA is the gold standard for measurement and description of gait However gait variability can arise from intrinsic ie caused by the persons natural gait variability and extrinsic ie methodological sources such as marker placement errors factors and may vary between walking conditions Follow-up andor pre- and post-intervention 3DGAs are used to determine the treatment for these children with CP So it is important to know when differences between 3DGAs can be seen as true differences or when the difference can be explained by intrinsicextrinsic gait variability
The purpose of the current study is to quantify the repeatability of gait in children with CP Therefore the repeatability between two 3DGAs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None