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PI2021_843_0208

Etiological study of persistent velopharyngeal insufficiency in children with operated velopalatine cleft by analysis of velopharyngeal motor skills in static and dynamic mri (fentirm)
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06072495
Velopharyngeal Insufficiency
real time MRI
Cleft palate
Source : Importé depuis le centre
Velopharyngeal Insufficiency
Real Time MRI
Cleft Palate
Recrutement ouvert
Dernière modification : 2023/10/19

Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Velopharyngeal Insufficiency

Real Time MRI

Cleft Palate

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

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
Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital
Whose follow-up is done at the Amiens University Hospital

Exclusion Criteria:

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
Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
Patients treated with fixed, non-removable orthodontic treatment.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
child with operated isolated labial cleft Donnée non disponible Donnée non disponible
  • Inconnu
  • child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy Donnée non disponible Donnée non disponible
  • Inconnu
  • child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy Donnée non disponible Donnée non disponible
  • Inconnu
  • child with isolated operated velopalatal cleft with normal anatomy and soft VPI Donnée non disponible Donnée non disponible
  • Inconnu
  • child with operated isolated labial cleft
    État du recrutement
    unknown
    child with isolated operated velopalatal cleft with severe VPI ( IIB//IIM) and normal velum anatomy
    État du recrutement
    unknown
    child with isolated operated velopalatal cleft with soft VPI (I/I-II) and abnormal velum anatomy
    État du recrutement
    unknown
    child with isolated operated velopalatal cleft with normal anatomy and soft VPI
    État du recrutement
    unknown
    Données à jour depuis : 19 octobre 2023

    Description de l'étude

    Résumé de l'étude

    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).

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 19 octobre 2023
    Données à jour depuis : 19 oct.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06072495