Radial Shockwave for Spasticity in Children With CP or ABI

NCT ID: NCT06909838

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-24
• Study Completion Date: 2025-06-05

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Conventional physiotherapy plan

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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

Shockwave and usual care

All participants receive a 4-week rESWT intervention plan (4 sessions with a one week interval), as add-on to the conventional physiotherapy plan

Group Type: EXPERIMENTAL

radial Extracorporeal shockwave therapy (rESWT)

Intervention Type: DEVICE

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

Conventional treatment

Intervention Type: OTHER

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

Interventions

radial Extracorporeal shockwave therapy (rESWT)

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

Intervention Type: DEVICE

Conventional treatment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FRAME Jessa Ziekenhuis, Belgium

UNKNOWN

Sponsor Role: collaborator

Gymna Uniphy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Aerssens, Pediatrician

Role: PRINCIPAL_INVESTIGATOR

MFC Sint Gerardus

Locations

Sint-Gerardus

Diepenbeek, Limburg, Belgium

Countries

Belgium

Other Identifiers

S68824

Identifier Type: -

Identifier Source: org_study_id