Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française55 enrolled

Overview

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)

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

Enrollment

Conditions

Cerebral Palsy Drooling

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Centre d'Education Motrice Jean-Marie Arnion - Odynéo

Dommartin, France

Centre d'Education Motrice Henry Gormand

Écully, France

Centre Hospitalier Universitaire Hôpital Nord

La Tronche, France

Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, France

Outcomes

Primary Outcomes

Change in Drooling Impact Scale

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).

Time frame: Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment

Secondary Outcomes

Internal consistency

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.

Time frame: All groups : at inclusion

Test-retest reliability

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.

Time frame: Control group : baseline and 1 month later

Responsiveness to change

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).

Time frame: Intervention group : baseline and 1 month after treatment.

Data from ClinicalTrials.gov

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