An interventional study of Focused Extracorporeal Shock Wave Therapy and Radial Extracorporeal Shock Wave Therapy in Spastic Quadriplegia, Cerebral Palsy (CP) and Gastrocnemius Muscle, sponsored by Dr Cipto Mangunkusumo General Hospital. Completed at 1 site in Indonesia. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Treatment
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:
Researchers will compare:
Participants will:
Dosing parameter is identical in both groups: 1,500 shocks, 2 bar, 6 Hz, medium energy intensity.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's enrollment of 16 is close to the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 39 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
Device: Focused Extracorporeal Shock Wave Therapy
Total impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
Device: Radial 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.
Also known as: fESWT, focused shockwave 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.
Also known as: rESWT, radial shockwave therapy
The Modified Ashworth Scale (MAS) score of the gastrocnemius muscle
The primary outcome was the Modified Ashworth Scale (MAS) score of the gastrocnemius muscle, recorded as an ordinal score on a 6-point scale (0, 1, 1.5, 2, 3, and 4), measuring resistance to passive stretch.
Time frame: The primary outcome was evaluated at baseline, post-intervention weeks 1 to 4, and follow-up at 4, 8, and 12 weeks post-final treatment by blinded outcome assessor.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared publicly due to the small sample size and privacy considerations for pediatric participants.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Dr Cipto Mangunkusumo General Hospital