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

NCT06494618 | Recruiting DMC

• 1 other identifier: CP BTX ESWT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cerebral Palsy, Spastic

Keywords

cerebral palsy; spasticity; botulinum toxin injection; extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (6)

• 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.)

Study Arms (2)

Botulinum Toxin Injection and Conventional Therapy

NO INTERVENTION

The group received conventional therapy (such as stretching exercises) after Botulinum Toxin Type A Injection for spastic lower extremity muscle groups.

Botulinum Toxin Injection and Shockwave Therapy

ACTIVE COMPARATOR

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

Interventions

Radial Extracorporeal Shockwave Therapy DEVICE

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.

Botulinum Toxin Injection and Shockwave Therapy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

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

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Belgin Erhan, Assoc. Prof.

  Istanbul Medeniyet University

  STUDY DIRECTOR

Central Study Contacts

Ismail Hakan Akbulut, Resident

CONTACT

+905549151240; hakan__akbulut@hotmail.com

Belgin Erhan, Assoc. Prof.

CONTACT

+905322678024; dr.belginerhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor were blinded to patients who received shockwave therapy and who did not received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation

Model Details: Pediatric patients diagnosed with cerebral palsy who received botulinum toxin injection for lower extremity spasticity were randomized 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 and their routine conventional therapy. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)