Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

• Sponsor: Gazi University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05295563
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Muscle Spasticity; Vascularization	Other: Evaluation

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Muscle morphology [Through study completion, an average of 1 year]

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

2. Muscle stiffness [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 [Through study completion, an average of 1 year]

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

4. Functionality 1 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gazi University	Ankara		Turkey

Sponsors and Collaborators

• Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamile Uzun Akkaya, Principal Investigator, Gazi University
• ClinicalTrials.gov Identifier: NCT05295563
• Other Study ID Numbers: KamileUzunAkkaya
• First Posted: Mar 25, 2022
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kamile Uzun Akkaya, Principal Investigator, Gazi University: Repeated botulinum toxin injections; Muscle morphology; Functionality
• Additional relevant MeSH terms: Muscle Spasticity; Cerebral Palsy; Neovascularization, Pathologic

Study Results

No Results Posted as of Mar 25, 2022