spasticity
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 3-18 years Diagnosis of spastic cerebral palsy Signed informed consent by parents (and the patient when aged above 12 years).
Exclusion criteria
Exclusion criteria: - Medication to reduce saliva production (glycopyrrolate, scopolamine, trihexyfenidyl) - Treatment with botulin toxin injections in the salivary glands in the past 32 weeks - Surgical treatment for drooling in the past. These exclusion criteria are included because they influence the functional outcome measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Thickness of orofacial muscles (digastrics muscle, masseter muscle, temporal muscle, tongue) and described as z-score (corrected for age, height and weight, based on own laboratory normal values). - Echogenicity of orofacial muscle (digastrics muscle, geniohyoid muscle, masseter muscle, temporal muscle) and described as z-score (corrected for age, height and weight, based on own laboratory normal values). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Performance of mastication (Mastication Observation Evaluation) - EDACS level - Drooling Quotient - Timed Test of Swallowing (ml/sec) - Pediatric Posterior Drooling Scale | — |
Countries
Netherlands