About this trial
Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 7 to 12 years with Isolated cleft lip
isolated velopalatal cleft
Without a diagnosis of syndromic cleft or Pierre Robin sequence
French speaking, and French is the native language
Disqualifiers
Refusal of the parents and/or the patient
With a contraindication to MRI
Whose follow-up was initiated in another center and/or whose surgery was performed in another center
Whose surgical schedule has not been followed
Trial design
Parallel
Treatments tested in this trial
real time MRI
Other interventionubjects will be scanned in the supine position using ACHIEVA 3T TX DStream Philips® and a 33 channels head and neck coil. An elastic strap will be fixed to the forehead to limits movement during scan. Headset will be used to cancel the loud MRI noise and to communicate with the subjects
Treatment groups
Trial outcomes
Primary outcomes
ratio between the diameter of pharynx at rest and during phonation.
closure distance between the velar knee and the posterior pharyngeal wall
distance between the velar knee and the posterior pharyngeal wall
Sponsors and contacts
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