Spasticity Due to Cerebral PalsyNCT06909838
Radial Shockwave for Spasticity in Children With CP or ABI
A study testing radial Extracorporeal shockwave therapy (rESWT) and Conventional treatment in people with Spasticity Due to Cerebral Palsy and Spasticity Post-Traumatic Brain Injury, run by Gymna Uniphy at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spasticity Due to Cerebral Palsy, Spasticity Post-Traumatic Brain Injury
- What is being tested?
- radial Extracorporeal shockwave therapy (rESWT) and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Sep 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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+.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- radial Extracorporeal shockwave therapy (rESWT), Conventional treatment
- Keywords
- Extracorporeal shockwave therapy, shockwave therapy, shock wave therapy, children, radial shockwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial Extracorporeal shockwave therapy (rESWT)Device
4 rESWT interventions, with a one week interval, are added to the conventional treatment plan
Conventional treatmentOther
Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,..
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Conventional physiotherapy plan Receives: 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 Receives: Device: radial Extracorporeal shockwave therapy (rESWT); Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Change from baseline to 3 months follow-up
Secondary outcomes (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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Change from baseline to 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start24 Sep 2024
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity Due to Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gymna Uniphy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Aerssens, Pediatrician, Principal investigator, MFC Sint Gerardus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909838
- Sponsor's protocol ID
- S68824
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Shockwave Therapy With ShockMaster 300® to Reduce Spasticity in Children With CP or Acquired Brain Injury: a Pilot Study
- ClinicalTrials.gov ID
- NCT06909838
- Acronym / sponsor ID
- S68824
- Keywords
- Extracorporeal shockwave therapy, shockwave therapy, shock wave therapy, children, radial shockwave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gymna UniphyIndustry (pharma, biotech, devices)
- Collaborators
- Jessa Hospital
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Conventional treatmentConventional physiotherapy plan |
| Shockwave and usual care | Experimental | Device: radial Extracorporeal shockwave therapy (rESWT), Other: Conventional treatmentAll participants receive a 4-week rESWT intervention plan (4 sessions with a one week interval), as add-on to the conventional physiotherapy plan |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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+.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radial Extracorporeal shockwave therapy (rESWT)4 rESWT interventions, with a one week interval, are added to the conventional treatment plan | Device | Shockwave and usual care |
| Conventional treatmentUsual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,.. | Other | Shockwave and usual care, Usual care |
Primary outcome
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).
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).
4 secondary outcomes
Patient Specific Functional Scale
Time frame: Change from baseline to the end of intervention sessions at week 4
Patient Specific Functional Scale
Time frame: Change from baseline to 3 months follow-up
passive Range Of Motion
Time frame: Change from baseline to the end of intervention sessions at week 4
passive Range Of Motion
Time frame: Change from baseline to 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Spasticity Due to Cerebral Palsy
Recruiting
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
CP (Cerebral Palsy)
Recruiting
Dorsal Root Electrical Stimulation in Children With Cerebral Palsy
Cerebral Palsy (CP), Cerebral Palsy
Enrolling by invitationObservational study
Intranasal AAV9-PHP.eB Gene Therapy in Cerebral Palsy (CP) & Hypoxic Ischemic Encephalopathy (HIE)
Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE)
Recruiting
Effect of Botulinum Toxin Type A on Motor Function in Children With Cerebral Palsy
Cerebral Palsy (CP), Spasticity Due to Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Aerssens, Pediatrician principal investigator
MFC Sint Gerardus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial Extracorporeal shockwave therapy (rESWT) and Conventional treatment in people with Spasticity Due to Cerebral Palsy and Spasticity Post-Traumatic Brain Injury, run by Gymna Uniphy at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: Change from baseline to the end of intervention sessions at week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.