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

ConditionCerebral Palsy, Spastic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIstanbul Medeniyet University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Having uncontrolled epilepsy.

Having infection

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Botulinum Toxin Injection and Conventional TherapyNo intervention 0 interventions
Group B: Botulinum Toxin Injection and Shockwave TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Aschworth Scale

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

Time frame
3 months (before injection, first week, first month and third month after injection.)
2

Modified Tradiue Scale

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

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

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.

Time frame
3 months (before injection, first week, first month and third month after injection.
4

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."

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Medeniyet University

Lead sponsor

Source ClinicalTrials.gov
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