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Completed

NCT Number: NCT06909838

Radial Shockwave for Spasticity in Children With CP or ABI

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.

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Key information

Conditions

Spasticity Due to Cerebral Palsy Spasticity Post-Traumatic Brain Injury

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint-Gerardus

Diepenbeek, Limburg, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radial Extracorporeal shockwave therapy (rESWT)

Device

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

conventional treatment

Other

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

Primary outcomes

  1. Modified Ashworth Scale

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

    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).

  2. Modified Ashworth Scale

    Time frame: Change from baseline to 3 months follow-up

    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).

Secondary outcomes

  1. Patient Specific Functional Scale

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

    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".

  2. Patient Specific Functional Scale

    Time frame: Change from baseline to 3 months follow-up

    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".

  3. passive Range Of Motion

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

    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.

  4. passive Range Of Motion

    Time frame: Change from baseline to 3 months follow-up

    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.

Sponsors and collaborators

Lead sponsor

Gymna Uniphy

Industry

Collaborators

  • FRAME Jessa Ziekenhuis, Belgium

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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