Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 4:51 AM
Study NCT ID:
NCT06610357
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Term Effects of Selective Dorsal Rhizotomy Surgery on Function and Mobility in Children With Cerebral Palsy Using the International Classification of Functioning, Disability, and Health (ICF) Model
Sponsor:
Acıbadem Atunizade Hospital
Organization:
Study Overview
Official Title:
Evaluation of Long-Term Effects of Selective Dorsal Rhizotomy Surgery on Function and Mobility in Children With Cerebral Palsy Using the International Classification of Functioning, Disability, and Health (ICF) Model
Status:
COMPLETED
Status Verified Date:
2024-09
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 (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills as a result of permanent, non-progressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). The worldwide prevalence of CP is 2-3 per 1000 live births (Paul et al., 2022). The most common type is spastic type CP with a prevalence rate of 70-80% (Christensen et al., 2014). Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014). In diparetic CP (DCP); lower extremity involvement is more prominent than upper extremity involvement (Elbasan et al., 2017). Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with spastic diparetic CP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020). Studies in the literature have revealed the long-term effects of SDR through surveys. Many problems are observed in individuals with CP. It is very important to evaluate the situation in detail in order to analyze it well. It is recommended to use the International Classification of Functioning, Disability and Health (ICF) model, which creates a framework to evaluate children with a diagnosis of DCP in a healthy way and develop effective treatment strategies (Riyahi et al., 2024). ICF enables the identification of situations related to human functionality and limitations and creates a framework (Çankaya \& Seyhan, 2016). The aim of this study is to evaluate the late effects of SDR surgery on function and mobility in cases with DCP using the ICF model.
Detailed Description:
It's an observational study. Purpose of the study: This study aims to assess the long-term impact of SDR surgery on function and mobility in children with CP using the ICF model.
The study included 42 diparetic CP cases. These cases were aged between 2-9 years, with a mean age of 4.7±1.7 years.
* How did the long-term the Modified Ashworth Scale (MAS) values after SDR change compared to before the operation?
* How did the long-term the Gross Motor Function Measure-88 (GMFM-88) values after SDR change compared to before the operation?
* How did the long-term the Children's Functional Independence Measure (WeeFIM)- Mobility scores after SDR change compared to before the operation?
The Modified Ashworth Scale (MAS), the Gross Motor Function Measure-88 (GMFM-88) and the Children's Functional Independence Measure (WeeFIM)-Mobility section were applied to the participants.
The study included 42 diparetic CP cases. These cases were aged between 2-9 years, with a mean age of 4.7±1.7 years.
* How did the long-term the Modified Ashworth Scale (MAS) values after SDR change compared to before the operation?
* How did the long-term the Gross Motor Function Measure-88 (GMFM-88) values after SDR change compared to before the operation?
* How did the long-term the Children's Functional Independence Measure (WeeFIM)- Mobility scores after SDR change compared to before the operation?
The Modified Ashworth Scale (MAS), the Gross Motor Function Measure-88 (GMFM-88) and the Children's Functional Independence Measure (WeeFIM)-Mobility section were applied to the participants.
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?: