Status:
COMPLETED
Radial Shockwave for Spasticity in Children With CP or ABI
Lead Sponsor:
Gymna Uniphy
Collaborating Sponsors:
FRAME Jessa Ziekenhuis, Belgium
Conditions:
Spasticity Due to Cerebral Palsy
Spasticity Post-Traumatic Brain Injury
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to determine if radial Extracorporeal shockwave therapy (rESWT) reduces spasticity in children with Cerbral Palsy (CP) or traumatic brain injury (TBI). The main ques...
Eligibility Criteria
Inclusion
- cerebral palsy or acquired brain injury
- between 6-18 years old;
- gross motor function classification ≥2;
- experiencing spasticity in the lower limb (calf muscles, hip adductor muscles or hamstring muscles) and/or in the upper limb (biceps muscle, wrist flexor muscles, finger flexor muscles) with Modified Ashworth Scores (MAS) ≥1+.
Exclusion
- recent (≤3 months) Botox injections or other recent (≤6 months) invasive intervention;
- local infections or wounds; neuropathy;
- severe organ dysfunction;
- severe psychosocial dysfunction that would not allow adhering to protocol;
- planned changes in medication dosage or medication scheme that might affect spasticity during a 4-month intervention and follow-up phase.
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06909838
Start Date
September 24 2024
End Date
June 5 2025
Last Update
July 11 2025
Active Locations (1)
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1
Sint-Gerardus
Diepenbeek, Limburg, Belgium, 3590