- What is the echogenicity (quantitative described as z-scores, based on own laboratory values and qualitatively described as Heckmatt gradations) of orofacial muscles (digastrics muscle, geniohyoid muscle, masseter muscle, temporal muscle) in…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- Performance of mastication (Mastication Observation Evaluation)
- EDACS level
- Drooling Quotient
- Timed Test of Swallowing (ml/sec)
- Pediatric Posterior Drooling Scale
Background summary
Children with cerebral palsy (CP) often have dysphagia (prevalence of 43 - 99%)
depending on the severity of the motor impairment. Observation of eating and
drinking and instrumental assessment (videofluoroscopic swallowing study) are
used to give a description of the eating and swallowing skills. However, these
assessments do not give insights in the underlying pathophysiology of the
problems: which muscles are affected in which way?
In the last years, quantitative muscle ultrasound is used in children with
neuromuscular disorders. With muscle ultrasound, the thickness and echogenicity
of a muscle can be determined. The echogenicity reflects the degree of density
of the measured tissue. Muscle tissue has a low echogenicity, and fat or
connective tissue and bone have a high echogenicity. Quantitative muscle
ultrasound of orofacial muscles provides insight into the underlying
pathological mechanisms of mastication and swallowing difficulties.
With the current research, a precise picture can be obtained of the (changed)
composition of the orofacial muscles and the relation with eating and
swallowing problems in children with CP. This knowledge can be a next step in
understanding the complex swallowing problems of the group of children with CP
and the way in which therapy has to be started in the form of exercises and
compensations. The different orofacial muscles (submental muscles, masticatory
muscles) all have their own function and influence on the activity to be
performed. If we have more insight in the affected muscles, we could also
examine whether influencing is possible through exercise. By visualizing these
muscles we can better explain the underlying mechanisms involved. With this
knowledge more differentiation can be made in therapy. This means an important
step for patients (and their parents) towards a better substantiated and more
targeted treatment of eating and swallowing problems in children with CP.
Study objective
- What is the echogenicity (quantitative described as z-scores, based on own
laboratory values and qualitatively described as Heckmatt gradations) of
orofacial muscles (digastrics muscle, geniohyoid muscle, masseter muscle,
temporal muscle) in children with CP?
- What is the thickness (quantitative described as z-scores, based on own
laboratory normal values) of orofacial muscles (digastrics muscle, masseter
muscle, temporal muscle and the tongue) in children with CP?
- Is there a relation between the echogenicity of orofacial muscles in children
with CP and the EDACS-level or other functional outcome measurements (about
mastication, swallowing and saliva control) and/or patient characteristics
(GMFCS, age, BMI)?
- Is there a relation between the thickness of orofacial muscles in children
with CP and the EDACS-level or other functional outcome measurements (about
mastication, swallowing and saliva control) and/or patient characteristics
(GMFCS, age, BMI)?
Study design
In 50 children with CP, visiting the outpatient clinic for Speech Language
Therapy, orofacial muscle ultrasound will be performed. Thickness and
echogenicity of orofacial muscle will be determined and will be described as
z-scores, corrected for age, height and weight (based on own laboratory
values). Children will be classified using the Eating and Drinking Ability
Classification System (EDACS). In all EDACS- levels (I-V), 10 patients with CP
will be included. Functional outcome measurements on mastication, swallowing
and saliva control (regular measurements during assessment in the Amalia
Children*s Hospital of the Radboudumc) will be described.
Study burden and risks
Time investment: 10 minutes within a regular visit at the outpatient clinic for
Speech and Language therapy.
There are no risks associated with participation to the study. The ultrasound
assessment is not invasive. For other patientgroups (neuromuscular diseases)
the ultrasound assessment is within regular care.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66563.091.18 |