Quantitative muscle ultrasound of orofacial muscles in children with cerebral palsy

Recruiting

• Conditions: spasticity; 10010335

• Registration Number: NL-OMON46117
• Lead Sponsor: afdeling Logopedie (kinderen), Afdeling Revalidatie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Thickness of orofacial muscles (digastrics muscle, masseter muscle, temporal<br /><br>muscle, tongue) and described as z-score (corrected for age, height and weight,<br /><br>based on own laboratory normal values).<br /><br>- Echogenicity of orofacial muscle (digastrics muscle, geniohyoid muscle,<br /><br>masseter muscle, temporal muscle) and described as z-score (corrected for age,<br /><br>height and weight, based on own laboratory normal values).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Performance of mastication (Mastication Observation Evaluation)<br /><br>- EDACS level<br /><br>- Drooling Quotient<br /><br>- Timed Test of Swallowing (ml/sec)<br /><br>- Pediatric Posterior Drooling Scale</p><br>