Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-18 @ 2:32 PM
Study NCT ID:
NCT06307561
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
Sponsor:
Acıbadem Atunizade Hospital
Organization:
Study Overview
Official Title:
The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
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:
Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
Detailed Description:
It's an observational study. Purpose of the study: Investigating the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
* Does dystonia severity affect participation in daily life activities in CP children with secondary dystonia?
* Does the severity of dystonia in children with CP with secondary dystonia affect the burden on the caregiver?
* Are the participation in daily living activities and caregiver burden of children with CP with secondary dystonia related to each other?
Total of 20 CP cases with secondary dystonia who applied to Acıbadem University Department of Pediatric Neurosurgery will be included in the study.
Dystonia severity of these cases will be evaluated with the Barry-Albright Dystonia Scale (BADS). Children's participation in daily living activities will be evaluated with The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), and the burden on the caregiver will be evaluated with the Care and Comfort Hypertonicity Questionnaire (CCHQ).
* Does dystonia severity affect participation in daily life activities in CP children with secondary dystonia?
* Does the severity of dystonia in children with CP with secondary dystonia affect the burden on the caregiver?
* Are the participation in daily living activities and caregiver burden of children with CP with secondary dystonia related to each other?
Total of 20 CP cases with secondary dystonia who applied to Acıbadem University Department of Pediatric Neurosurgery will be included in the study.
Dystonia severity of these cases will be evaluated with the Barry-Albright Dystonia Scale (BADS). Children's participation in daily living activities will be evaluated with The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), and the burden on the caregiver will be evaluated with the Care and Comfort Hypertonicity Questionnaire (CCHQ).
Study Oversight
Has Oversight DMC:
False
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?: