Clinical trial NCT06610357: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diplegic Cerebral Palsy
Muscle Tone Abnormalities
Keywords: Cerebral Palsy
ICF
Muscle Tone
Mobility
Long-Term effects
Selective Dorsal Rhizotomy
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 42
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 42 children with Diparetic Cerebral Palsy were included in the study.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Modified Ashworth Scale (MAS)
timeFrame: baseline
measure: The Gross Motor Function Measure-88 (GMFM-88)
timeFrame: baseline
measure: The Children's Functional Independence Measure (WeeFIM)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
state: AA
Study officials:
References: