Clinical trial NCT03986333: Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population
Official title: Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Drooling
Lead sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 55
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty-five children were included, 33 in the stable group and 22 in the intervention group.

Brief summary: The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy (CP)

Detailed description: Drooling in children with CP is likely underestimated and under treated. It is an over-handicap for these children, because it causes many complications and may lead to a decline in self-esteem and to social isolation, altering the quality of life for patients and families. The therapeutic arsenal for the management of drooling includes rehabilitation techniques, oral drug treatments, local treatments or surgical treatments whose effectiveness is variable. In order to evaluate the efficacy of these therapies, standardized and valid assessment tools must be used. The Drooling Impact Scale (DIS) developed by Dr. Sue Reid's team in Melbourne in 2008, shows good validity and sensitivity to change, especially after botulinum toxin injection. It is commonly used in English-speaking studies, but no validation in French is available yet.

The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with CP.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy
* Hypersialorrhea
* No change in content and frequency of speech therapy for three months following baseline
* At least 1 out of 2 parents must have a clear understanding of french language
* Oral consent

Exclusion Criteria:

* No clear understanding of french language

Primary outcomes:
measure: Change in Drooling Impact Scale
timeFrame: Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment
Secondary outcomes:
measure: Internal consistency
timeFrame: All groups : at inclusion
measure: Test-retest reliability
timeFrame: Control group : baseline and 1 month later
measure: Responsiveness to change
timeFrame: Intervention group : baseline and 1 month after treatment.
Other outcomes:
Locations:
city: Dommartin
country: France
facility: Centre d'Education Motrice Jean-Marie Arnion - Odynéo
city: Ecully
country: France
facility: Centre d'Education Motrice Henry Gormand
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Hôpital Nord
city: Lyon
country: France
facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
city: Marseille
country: France
facility: AP-HM Hôpital de la Timone
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: CMCR des Massues Croix rouge française
name: Emmanuelle Chaléat-Valayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: