Radial Shockwave for Spasticity in Children With CP or ABI

Radial Shockwave Therapy With ShockMaster 300® to Reduce Spasticity in Children With CP or Acquired Brain Injury: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Spasticity Due to Cerebral Palsy; Spasticity Post-Traumatic Brain Injury
• Intervention / Treatment: Other: Conventional treatment; Device: radial Extracorporeal shockwave therapy (rESWT)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Sint-Gerardus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Conventional physiotherapy plan	Other: Conventional treatment; Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,..
Experimental: 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	Other: Conventional treatment; Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,..; Device: radial Extracorporeal shockwave therapy (rESWT); 4 rESWT interventions, with a one week interval, are added to the conventional treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Specific Functional Scale	The PSFS focuses on the patient's opinion of their function, and requires the physiotherapist to ask the patient to list three activities that are limited by the condition for which they are seeking treatment. The current level of difficulty associated with the activities is rated on a 11 point scale, where "0" represents "unable to perform activity" and "10" represents "able to perform at prior level".	Change from baseline to the end of intervention sessions at week 4
Patient Specific Functional Scale	The PSFS focuses on the patient's opinion of their function, and requires the physiotherapist to ask the patient to list three activities that are limited by the condition for which they are seeking treatment. The current level of difficulty associated with the activities is rated on a 11 point scale, where "0" represents "unable to perform activity" and "10" represents "able to perform at prior level".	Change from baseline to 3 months follow-up
passive Range Of Motion	Passive range of motion (PROM) is the ROM that is achieved when a therapist exclusively causes movement of a joint and is usually the maximum range of motion that a joint can move. An increasing ROM in spasticity helps maintain or increase the extensibility of soft tissue and joints, reduces pain, improves function and can normalize muscle tone.	Change from baseline to the end of intervention sessions at week 4
passive Range Of Motion	Passive range of motion (PROM) is the ROM that is achieved when a therapist exclusively causes movement of a joint and is usually the maximum range of motion that a joint can move. An increasing ROM in spasticity helps maintain or increase the extensibility of soft tissue and joints, reduces pain, improves function and can normalize muscle tone.	Change from baseline to 3 months follow-up

Collaborators and Investigators

• Sponsor: Gymna Uniphy
• Collaborators: FRAME Jessa Ziekenhuis, Belgium
• Investigators: Principal Investigator: Peter Aerssens, Pediatrician, MFC Sint Gerardus

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: children; Extracorporeal shockwave therapy; shock wave therapy; shockwave therapy; radial shockwave therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Brain Injuries, Traumatic; Muscle Spasticity; Brain Injuries; Cerebral Palsy
• Other Study ID Numbers: S68824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No