Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340425
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-01
Brief Title:
The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy a Retrospective Study
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy a Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Cerebral palsy or CP is the single largest cause of childhood physical disability with a prevalence of 2-3 per 1000 livebirths Children with CP experience different primary symptoms including abnormal increased muscle tone or spasticity Selective dorsal rhizotomy SDR is applied in children with spastic CP as a non-reversible tone reduction procedure Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making
Detailed Description:
Cerebral palsy or CP is the single largest cause of childhood physical disability with a prevalence of 2-3 per 1000 livebirths Children with CP experience different primary symptoms including abnormal increased muscle tone or spasticity Selective dorsal rhizotomy SDR is applied in children with spastic CP as a non-reversible tone reduction procedure During this neurosurgical procedure dorsal rootlets are transected to diminish the excitatory input from the afferents resulting in a reduction of the abnormal increased muscle tone Although different studies investigated the SDR-effect on separate sets of outcomes such as spasticity gait or gross motor function no study so far has studied SDR-effects on combined outcome sets in one CP-cohort or on macroscopic muscle morphology
The discrepancy between results of different previous studies highlight the added value of a multidimensional outcome set assessed within one cohort Integrating outcomes of different levels will provide a better insight on how effects do or do not occur Additionally although SDR does not directly intervene with the macroscopic muscle structures reducing the excitatory input from the afferents could potentially have an effect on muscle growth Indicating macroscopic muscle morphology as an important outcome
The current study will investigate the added value of a multidimensional outcome set assessed in one single cohort Important gaps in the literature will be addressed including the effect of SDR on muscle morphology and the use of instrumented assessments The primary objective of this study was to investigate changes in a multidimensional outcome set including spasticity muscle morphology gait and gross motor function pre- and post-SDR in one single cohort of children with spastic CP As a secondary objective this study will compare outcomes of the clinical examination spasticity range of motion strength selectivity pre- and post-SDR Additionally muscle morphology will be qualitatively compared in children with CP who received an SDR to children with CP without an SDR intervention
The discrepancy between results of different previous studies highlight the added value of a multidimensional outcome set assessed within one cohort Integrating outcomes of different levels will provide a better insight on how effects do or do not occur Additionally although SDR does not directly intervene with the macroscopic muscle structures reducing the excitatory input from the afferents could potentially have an effect on muscle growth Indicating macroscopic muscle morphology as an important outcome
The current study will investigate the added value of a multidimensional outcome set assessed in one single cohort Important gaps in the literature will be addressed including the effect of SDR on muscle morphology and the use of instrumented assessments The primary objective of this study was to investigate changes in a multidimensional outcome set including spasticity muscle morphology gait and gross motor function pre- and post-SDR in one single cohort of children with spastic CP As a secondary objective this study will compare outcomes of the clinical examination spasticity range of motion strength selectivity pre- and post-SDR Additionally muscle morphology will be qualitatively compared in children with CP who received an SDR to children with CP without an SDR intervention
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