Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

March 5, 2024 updated by: Kamile Uzun Akkaya, Gazi University

Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy

One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years, who had previously been injected with BoNT-A into the gastrocnemius muscle, who can cooperate were included in the study.

Description

Inclusion Criteria:

  • Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years
  • Children who had previously been injected with BoNT-A into the gastrocnemius muscle

Exclusion Criteria:

  • Children with dyskinetic, ataxic, and hypotonic type CP
  • Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Children who had been injected once or twice before were included in Group 1.
Other: Evaluation
Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated.
Group 2
Children who received 3 or more injections were included in Group 2.
Other: Evaluation
Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle morphology
Time Frame: Through study completion, an average of 1 year
Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Through study completion, an average of 1 year
Muscle stiffness
Time Frame: Through study completion, an average of 1 year
Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Through study completion, an average of 1 year
Muscle vascularization
Time Frame: Through study completion, an average of 1 year
Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Through study completion, an average of 1 year
Functionality 1
Time Frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Through study completion, an average of 1 year
Functionality 2
Time Frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
Through study completion, an average of 1 year
Functionality 3
Time Frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Through study completion, an average of 1 year
Functionality 4
Time Frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Gazi University

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, 2021

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KamileUzunAkkaya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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