Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population
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|ClinicalTrials.gov Identifier: NCT03986333|
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease|
|Cerebral Palsy Drooling|
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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2018|
Children whose drooling was expected to remain relatively stable over 1 month
Children receiving a treatment to reduce their drooling
- Change in Drooling Impact Scale [ Time Frame: Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment ]The severity of drooling is assessed from the parents perception, by the Drooling Impact Scale. This scale consists of a set of ten items exploring the impact of drooling on daily life activities and relationships, each measured on a scale of 1 to 10 (1 representing the lowest impact of drooling, 10 the highest).
- Internal consistency [ Time Frame: All groups : at inclusion ]Internal consistency was assessed by calculating the Cronbach's alpha coefficient from scores obtained at inclusion. A correlation coefficient of at least 0.7 was defined as indicative of adequate inter-relatedness of items. The Pearson correlation matrix was used to define the linear relationships between items.
- Test-retest reliability [ Time Frame: Control group : baseline and 1 month later ]The Lin concordance correlation coefficient was used to compute the level of agreement between the two assessments. In addition, the Bland-Altman limits-of-agreement method for assessing test-retest reliability was used as a complementary approach.
- Responsiveness to change [ Time Frame: Intervention group : baseline and 1 month after treatment. ]An estimate of the responsiveness or sensitivity to change of the measure was obtained using four statistical methods : effect size, standardized response mean,Guyatt responsiveness statistics, unpaired t-test (Wilcoxon test).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986333
|Centre d'Education Motrice Jean-Marie Arnion - Odynéo|
|Dommartin, France, 69380|
|Centre d'Education Motrice Henry Gormand|
|Ecully, France, 69130|
|Centre Hospitalier Universitaire Hôpital Nord|
|La Tronche, France, 38700|
|Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues|
|Lyon, France, 69005|
|AP-HM Hôpital de la Timone|
|Marseille, France, 13385|
|Centre Hospitalier Universitaire de Nîmes|
|Nîmes, France, 30029|
|Principal Investigator:||Emmanuelle Chaléat-Valayer, PhD||CMCR des Massues Croix rouge française|