NCT05295563

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 8, 2022

Last Update Submit

March 5, 2024

Conditions

Cerebral PalsyMuscle SpasticityVascularization

Keywords

Repeated botulinum toxin injectionsMuscle morphologyFunctionality

Outcome Measures

Primary Outcomes (7)

  • Muscle morphology

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

    Through study completion, an average of 1 year

  • Muscle stiffness

    Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.

    Through study completion, an average of 1 year

  • Muscle vascularization

    Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.

    Through study completion, an average of 1 year

  • Functionality 1

    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

    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

    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

    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

Study Arms (2)

Group 1

Children who had been injected once or twice before were included in Group 1.

Other: Evaluation

Group 2

Children who received 3 or more injections were included in Group 2.

Other: Evaluation

Interventions

EvaluationOTHER

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 1Group 2

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle SpasticityNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMetaplasiaPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 25, 2022

Study Start

May 1, 2021

Primary Completion

May 30, 2022

Study Completion

May 31, 2022

Last Updated

March 6, 2024

Record last verified: 2022-03

Locations

TU(1)