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

Istanbul Medeniyet University

Status: Enrolling

Conditions: Cerebral Palsy, Spastic

Treatments: Device: Radial Extracorporeal Shockwave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06494618

CP BTX ESWT

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Botulinum Toxin Injection and Conventional Therapy

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Radial Extracorporeal Shockwave Therapy