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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Device: Radial Extracorporeal Shockwave Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismail Hakan Akbulut, Resident; Phone Number: +905549151240; Email: hakan__akbulut@hotmail.com
• Study Contact Backup: Name: Belgin Erhan, Assoc. Prof.; Phone Number: +905322678024; Email: dr.belginerhan@gmail.com

Study Locations

• Turkey
  • Kadikoy
    • Istanbul, Kadikoy, Turkey, 34722
      • Recruiting
      • Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
      • Contact: Ismail Hakan Akbulut, Resident; Phone Number: +905549151240; Email: hakan__akbulut@hotmail.com
      • Contact: Belgin Erhan, Assoc. Prof.; Phone Number: +905322678024; Email: dr.belginerhan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 lower extremity.
• Agreed to participate to study (patient/primary caregiver)

Exclusion Criteria:

• Surgery history within the last year of the muscle to be injected and treated
• Having uncontrolled epilepsy.
• Having infection
• Coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Botulinum Toxin Injection and Conventional Therapy; The group received conventional therapy (such as stretching exercises) after Botulinum Toxin Type A Injection for spastic lower extremity muscle groups.
Active Comparator: Botulinum Toxin Injection and Shockwave Therapy; The group received extracorporeal shockwave therapy conventional therapy (such as stretching exercises). Shockwave therapy is planned 3 sessions, starting first week after injection. It is planned to apply 1500 pulses, 4 hertz, 2 bars radial eswt to the injected spastic muscle groups in each session. The patients in this group will continue to their conventional therapy like the first group.	Device: Radial Extracorporeal Shockwave Therapy; 1500 pulses, 4 hertz, 2 bar radial extracorporeal shockwave therapy targeted muscle belly for botulinum toxin injected lower extremity muscle groups. 3 sessions were planned once a week, starting from first week after injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Aschworth Scale	Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.	3 months (before injection, first week, first month and third month after injection.)
Modified Tradiue Scale	Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.	3 months (before injection, first week, first month and third month after injection.)
Modified Timed Up and Go Test	The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded.	3 months (before injection, first week, first month and third month after injection.
Facies Pain Scale Revised	The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."	3 months (before injection, first week, first month and third month after injection.)
Passive Range of Motion	Goniometric measurement of the range of motion of the joint of the injected muscle	3 months (before injection, first week, first month and third month after injection.)
Goal Attaintment Scale	The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2. Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2	3 months (before injection, first week, first month and third month after injection.)

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Study Director: Belgin Erhan, Assoc. Prof., Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: spasticity; cerebral palsy; extracorporeal shockwave therapy; botulinum toxin injection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Muscle Spasticity; Cerebral Palsy; Paralysis
• Other Study ID Numbers: CP BTX ESWT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No