- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06617507
The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Altunizade
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Istanbul, Altunizade, Turkey, 34662
- Acıbadem Altunizade Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children with diparetic cerebral palsy
20 ambulatory diparetic CP cases were included.
The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.
|
The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified Ashworth Scale (MAS)
Time Frame: baseline
|
It is a 6-point scale used to describe the muscle's resistance to passive movement and the ease with which the joint can be moved within the available range.
It is frequently used in clinical settings.
Its evaluation and interpretation are quite practical.
Within the scope of the study, lower extremity muscles were evaluated with MAS.
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baseline
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The Gillette Functional Assessment Questionnaire (FAQ)
Time Frame: baseline
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It is a measurement tool used to evaluate walking ability and functional mobility in children.
This questionnaire was developed specifically to evaluate the walking functions of children with CP and other neuromuscular disorders.
Developed at Gillette Children's Hospital, this survey aims to rate children's walking abilities in different environments.
Scores children's walking skills between 1-10.
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baseline
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The Edinburgh Visual Gait Score (EVGS)
Time Frame: baseline
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EVGS is a valid and reliable gait analysis method used in gait evaluation in children with CP.
It is a practically used gait analysis that supports observational gait analysis, especially in children with CP with mild involvement and distal deformities.
In EVGS, evaluation is made by video recording method.
It consists of 17 parameters and evaluates gait in frontal, sagittal and transverse planes.
In each lower extremity, 6 anatomical regions, namely trunk, pelvis, hip, knee, ankle and foot, are evaluated separately during the stance and swing phases of gait.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gizem Gürzoğlu, Acıbadem Atunizade Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GGurzoglu2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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