The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey

September 25, 2024 updated by: Gizem Gurzoglu, Acıbadem Atunizade Hospital

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

Completed

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

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Altunizade
      • Istanbul, Altunizade, Turkey, 34662
        • Acıbadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
baseline
The Gillette Functional Assessment Questionnaire (FAQ)
Time Frame: baseline
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.
baseline
The Edinburgh Visual Gait Score (EVGS)
Time Frame: baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gizem Gürzoğlu, Acıbadem Atunizade Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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