Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| FRAME Jessa Ziekenhuis, Belgium | UNKNOWN |
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Conventional physiotherapy plan |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radial Extracorporeal shockwave therapy (rESWT) | Device | 4 rESWT interventions, with a one week interval, are added to the conventional treatment plan |
|
| 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 |
| 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". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Aerssens, Pediatrician | MFC Sint Gerardus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint-Gerardus | Diepenbeek | Limburg | 3590 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional treatment | Other | Usual conventional therapy, including physiotherapy, ergotherapy, hippotherapy,.. |
|
| 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 |