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NCT Number: NCT06494618

Effects of Botulinum Toxin 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

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Key information

Conditions

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

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Modified Aschworth Scale

    Time frame: 3 months (before injection, first week, first month and third month after injection.)

    Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.

  2. Modified Tradiue Scale

    Time frame: 3 months (before injection, first week, first month and third month after injection.)

    Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.

  3. Modified Timed Up and Go Test

    Time frame: 3 months (before injection, first week, first month and third month after injection.

    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.

  4. Facies Pain Scale Revised

    Time frame: 3 months (before injection, first week, first month and third month after injection.)

    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."

  5. Passive Range of Motion

    Time frame: 3 months (before injection, first week, first month and third month after injection.)

    Goniometric measurement of the range of motion of the joint of the injected muscle

  6. Goal Attaintment Scale

    Time frame: 3 months (before injection, first week, first month and third month after injection.)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Belgin Erhan, Assoc. Prof.

CONTACT

[email protected]

+905322678024

Ismail Hakan Akbulut, Resident

CONTACT

[email protected]

+905549151240

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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