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Completed

NCT Number: NCT05295563

Effects of Repeated Botulinum Toxin Injections 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Metaplasia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Neovascularization, Pathologic Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascularization

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation

Other

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.

Primary outcomes

  1. Muscle morphology

    Time frame: Through study completion, an average of 1 year

    Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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