Viewing Study NCT06610357



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06610357
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-20

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: None
Organization: None

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: No
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: Its 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 4717 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 Childrens 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 Childrens Functional Independence Measure WeeFIM-Mobility section were applied to the participants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None