Spasticity Due to Cerebral Palsy, Spasticity Post-Traumatic Brain Injury
Conditions
Keywords
Extracorporeal shockwave therapy, shockwave therapy, shock wave therapy, children, radial shockwave therapy
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.
Interventions
DEVICEradial Extracorporeal shockwave therapy (rESWT)
4 rESWT interventions, with a one week interval, are added to the conventional treatment plan
OTHERConventional treatment
Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,..
Sponsors
FRAME Jessa Ziekenhuis, Belgium
Gymna Uniphy
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Functional Scale | 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. |
| passive Range Of Motion | 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. |
Countries
Belgium
Outcome results
None listed