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临床试验/NCT06610357
NCT06610357已完成不适用

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

Acıbadem Atunizade Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
The Modified Ashworth Scale (MAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
0 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Their ages must be between 0-17,
  • They must be diagnosed with diparetic CP,
  • The participants and their parents want to participate in the study voluntarily
  • The Gross Motor Function Classification System (GMFSS) level II-IV
  • Having a sitting level between 4-8 according to the Level Sitting Scale (LSS)
  • Actively continuing the Physiotherapy and Rehabilitation (PTR) program for at least 2 months in the post-operative period.

排除标准

  • Having different types of CP such as dyskinetic, ataxic and mixed type
  • Having spastic quadriparetic or hemiparetic type of CP
  • Having any surgical history on the musculoskeletal system,
  • Having Botulinum Toxin injection within the last 6 months.

结局指标

主要结局

The Modified Ashworth Scale (MAS)

时间窗: baseline

It is used to describe the muscle's resistance to passive movement, the ease with which the joint can be moved within the available range. It is a 6-point scale that measures the muscle's resistance to passive movement by passively moving the joint through its possible normal range of motion. Within the scope of the study, lower extremity muscles; hip flexors, hip adductors, hip internal rotators, knee flexors, knee extensors and ankle plantar flexors will be evaluated with MAS.

The Gross Motor Function Measure-88 (GMFM-88)

时间窗: baseline

It is an observational scale developed to evaluate the gross motor skills of children with CP and identify limitations. Gross motor function is evaluated in 5 sections: supine position and rolling over, sitting, crawling and kneeling, standing and walking-running and jumping. It consists of a total of 88 items. Each item is scored as 0, 1, 2, 3 or "not tested" and the total score and percentage (%) are calculated.

The Children's Functional Independence Measure (WeeFIM)

时间窗: baseline

It was developed to evaluate the functional independence levels of children with developmental disorders in daily living activities. The scale consists of 6 parts: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored between 1-7. 1 point, complete dependence; 7 points indicate complete independence. A total of minimum 18 (fully dependent) points and a maximum of 126 (fully independent) points can be obtained.

次要结局

未报告次要终点

研究者

发起方
Acıbadem Atunizade Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Neslihan Yildizdagi

Pediatric Physiotherapist

Acıbadem Atunizade Hospital

研究点 (1)

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