Clinical trial NCT06617507: The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey
Official title: The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy Spastic Diplegia
Gait, Spastic
Keywords: Cerebral Palsy
Gait
Selective Dorsal Rhizotomy
Ambulation
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.

Brief summary: Cerebral Palsy (CP) is a motor disorder that develops during fetal brain development or due to non-progressive damage to the developing infant brain. These movement and posture disorders are classified as Spastic Type, Dyskinetic Type, Ataxic Type and Mixed Type (Rosenbaum, 2007). Spastic type CP accounts for 20% of all CP cases. Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014).

Lower extremity involvement is more common in diparetic cerebral palsy (DCP) (Donker et al., 2008). 98% of DCP cases vary between GMFS levels I and III. Walking rates are between 86-91% (Novak et al., 2014). Children with DCP can usually walk until the age of 4 (Cottalorda, 1998). However, these walks are often; Due to spasticity, muscle weakness, involuntary co-contraction, deficiencies in selective motor control, balance problems, structural changes of soft tissue and compensatory mechanisms (Manca, 2014), it can lead to musculoskeletal system problems and gait pathologies. Although the cerebral lesion that causes is static, children with spastic diplegia increase in height with age, and they may lose their ability to walk because bone length cannot be accompanied by muscle length at the same rate (Miller, 2020).

Selective Dorsal Rhizotomy (SDR) surgery is an effective method for spasticity management in children with spastic DCP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020).

It has been stated that SDR surgery applied to carefully selected candidates may be beneficial on gait quality in individuals with ambulatory CP (Chen, 2019). SDR surgery has been found to improve walking as a result of information collected from patients through a survey (Park, 2021). The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.

Detailed description: It's an observational study. Purpose of the study: The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.

A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.

* What is the effect of SDR surgery performed in Turkey on gait function in children with CP?
* How did the muscle tone of the participants change after the SDR operation?

The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 0-17
* Being diagnosed with Diparetic CP, one of the types of Cerebral Palsy

Exclusion Criteria:

* Having any history of orthopedic surgery on the musculoskeletal system
* Having Botulinum Toxin injection in the last 6 months
* Using of Baclofen Pump

Primary outcomes:
measure: The Modified Ashworth Scale (MAS)
timeFrame: baseline
measure: The Gillette Functional Assessment Questionnaire (FAQ)
timeFrame: baseline
measure: The Edinburgh Visual Gait Score (EVGS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
state: Altunizade
Study officials:
affiliation: Acıbadem Atunizade Hospital
name: Gizem Gürzoğlu
role: STUDY_DIRECTOR
References: