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Radial Shockwave for Spasticity in Children With CP or ABI

NCT06909838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-11

No results posted yet for this study

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 questions it aims to answer are:

* Is it feasible to implement radial shockwave therapy in conventional physiotherapy plan in children with CP or TBI?
* Is it safe and effective to use rESWT for reducing spasticity in children with CP or TBI? Participants will receive a 4 week therapy intervention, as add on to the conventional physio (usual care), including one rESWT session per week for a total of 4 sessions.

Conditions

  • Spasticity Due to Cerebral Palsy
  • Spasticity Post-Traumatic Brain Injury

Interventions

DEVICE

radial Extracorporeal shockwave therapy (rESWT)

4 rESWT interventions, with a one week interval, are added to the conventional treatment plan

OTHER

Conventional treatment

Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,..

Sponsors & Collaborators

  • FRAME Jessa Ziekenhuis, Belgium

    collaborator UNKNOWN

  • Gymna Uniphy

    lead INDUSTRY

Principal Investigators

  • Peter Aerssens, Pediatrician · MFC Sint Gerardus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2025-06-05
Completion
2025-06-05

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909838 on ClinicalTrials.gov