Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy

Last updated: March 8, 2025
Sponsor: Istanbul Medeniyet University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Spasticity

Cataplexy

Cerebral Palsy

Treatment

Radial Extracorporeal Shockwave Therapy

Clinical Study ID

NCT06494618
CP BTX ESWT
  • Ages 2-18
  • All Genders

Study Summary

This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with cerebral palsy.

  • Spasticity in at least one of the lower extremity muscle groups.

  • No contraindications to shockwave therapy.

  • Applied Botulinum Toxin Type A injection for at least one spastic muscle of lowerextremity.

  • Agreed to participate to study (patient/primary caregiver)

Exclusion

Exclusion Criteria:

  • Surgery history within the last year of the muscle to be injected and treated

  • Having uncontrolled epilepsy.

  • Having infection

  • Coagulopathy

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Radial Extracorporeal Shockwave Therapy
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
June 30, 2025

Study Description

20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.

Connect with a study center

  • Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, Kadikoy 34722
    Turkey

    Active - Recruiting

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