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

Cerebral Palsy Clinical Trial

Official title:

Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986333
• Other study ID #: DROOLING
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Drooling
• Sialorrhea

Locations

Country	Name	City	State
France	Centre d'Education Motrice Jean-Marie Arnion - Odynéo	Dommartin
France	Centre d'Education Motrice Henry Gormand	Ecully
France	Centre Hospitalier Universitaire Hôpital Nord	La Tronche
France	Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues	Lyon
France	AP-HM Hôpital de la Timone	Marseille
France	Centre Hospitalier Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment
Secondary	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.	All groups : at inclusion
Secondary	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.	Control group : baseline and 1 month later
Secondary	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).	Intervention group : baseline and 1 month after treatment.