Radial Shockwave for Spasticity in Children With CP or ABI

NCT06909838 | Completed DMC

• 1 other identifier: S68824
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Extracorporeal shockwave therapy; shockwave therapy; shock wave therapy; children; radial shockwave therapy

Outcome Measures

Primary Outcomes (2)

• Modified Ashworth Scale

  The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion. The scale is validated for use in various clinical populations to measure spasticity. The MAS score varies form 0 (no increase in tone) up to 4 (limb rigid in flexion or extension).

  Change from baseline to the end of intervention sessions at week 4

• Modified Ashworth Scale

  The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion. The scale is validated for use in various clinical populations to measure spasticity. The MAS score varies form 0 (no increase in tone) up to 4 (limb rigid in flexion or extension).

  Change from baseline to 3 months follow-up

Secondary Outcomes (4)

• Patient Specific Functional Scale

  Change from baseline to the end of intervention sessions at week 4

• Patient Specific Functional Scale

  Change from baseline to 3 months follow-up

• passive Range Of Motion

  Change from baseline to the end of intervention sessions at week 4

• passive Range Of Motion

  Change from baseline to 3 months follow-up

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Conventional physiotherapy plan

Other: Conventional treatment

Shockwave and usual care

EXPERIMENTAL

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

Device: radial Extracorporeal shockwave therapy (rESWT); Other: Conventional treatment

Interventions

radial Extracorporeal shockwave therapy (rESWT) DEVICE

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

Shockwave and usual care

Conventional treatment OTHER

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

Shockwave and usual care; Usual care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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+.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gymna Uniphy: lead
• FRAME Jessa Ziekenhuis, Belgium: collaborator

Study Sites (1)

Sint-Gerardus

Diepenbeek, Limburg, 3590, Belgium

Location

Study Officials

• Peter Aerssens, Pediatrician

  MFC Sint Gerardus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: September 24, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)