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COMPLETED
NCT07894003
NA

Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy

Sponsor: Dr Cipto Mangunkusumo General Hospital

View on ClinicalTrials.gov

Summary

The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are: 1. Does focused ESWT (fESWT) reduce gastrocnemius spasticity more effectively than radial ESWT (rESWT)? 2. Are the antispastic effects of fESWT more durable over time compared with rESWT? Researchers will compare: * fESWT group (one session weekly, 4 weeks) * rESWT group (one session weekly, 4 weeks) to see if fESWT more effective to lower Modified Ashworth Scale (MAS) scores during all assessment time points compared with rESWT. Participants will: * Be randomly assigned to either fESWT or rESWT group. * Receive one treatment session per week for 4 consecutive weeks. * Undergo MAS score evaluations at: baseline, post-intervention weeks 1-4, and follow-up at 4, 8, and 12 weeks after the final treatment.

Official title: Comparison of Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy: A Pilot Randomized Control

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-12-12

Completion Date

2026-09-14

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DEVICE

Focused Extracorporeal Shock Wave Therapy

Focused ESWT (fESWT) generates true acoustic shockwaves that converge at a defined focal point within deeper tissue. Dosing parameters: total impulses 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.

DEVICE

Radial Extracorporeal Shock Wave Therapy

Radial ESWT (rESWT) uses pneumatic acceleration of a projectile that produces pressure waves diverging from the applicator tip, with maximal energy at the skin surface and progressively decreasing energy with depth. Dosing parameters: 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.

Locations (1)

Dr. Cipto Mangunkusumo National General Hospital (RSCM)

Jakarta Pusat, DKI Jakarta, Indonesia