The efficacy of 1,500 shots vs 750 shots of ESWT in spasticity reduction of gastrocnemius in spastic cerebral palsy.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210429003

Enrollment

Registered

2021-04-29

Start date

2021-01-11

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrocnemius spasticity in children with cerebral palsy Gastrocnemius, spasticity, extracorporeal shockwave therapy, cerebral palsy

Interventions

Focus ESWT 750 shots, intensity 1 (0.03 mJ/mm2), Frequency 5 Hz,Focus ESWT 1,500 shots, intensity 1 (0.03 mJ/mm2), Frequency 5 Hz,Sham Focus ESWT

Experimental Procedure/Surgery,Experimental Procedure/Surgery,Sham Comparator Procedure/Surgery

Focus ESWT 750 shots,Focus ESWT 1,500 shots,Sham focus ESWT

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1.Age between 2 and 15 years 2.Verified diagnosis of spastic CP by a physiatrist or pediatric neurologist 3.Spastic of lower limbs with MAS equal or more than 1+ 4.Sign informed consent by parents or legal guardian 5.No history of previous treatment with botulinum toxin within 7 months before the procedure 6.No history of dose adjustment of antispastic drug within 1 month before the procedure 7.No history of previous surgery interventions in the area of leg, ankle and foot within a year before the procedure

Exclusion criteria

Exclusion criteria: 1.Spastic of gastrocnemius with modified tardieu scale 5 or modified tardieu angle more than 20 degrees 2.Have deformity or contracture of lower legs, knees and ankles 3.Have dislocation of hip 4.Have precaution for ESWT: coagulopathy, thrombocytopenia, local infection 5.The participants are attending in other study

Design outcomes

Primary

Measure	Time frame
Gastrocnemius spasticity Immediately, 1 month and 3 months after end of the intervention Modified tardieu angle	—

Secondary

Measure	Time frame
Gastrocnemius spasticity Immediately, 1 month and 3 months after end of the intervention Modified tardieu grade,Gastrocnemius spasticity Immediately, 1 month and 3 months after end of the intervention Modified ashworth scale,Visual analog scale to assess parented quantification of spasticity Before the intervention, Immediately, 1 month and 3 months after end of the intervention VAS of spasticity	—

Countries

Thailand

Contacts

Public ContactChonnanid Limsakul

Rehabilitation department, Faculty of medicine, Prince of Songkla University

Chonnanid@hotmail.com074281601

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026