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

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

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)

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Drooling

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Dommartin, France, 69380
    • Centre d'Education Motrice Jean-Marie Arnion - Odynéo
  • Ecully, France, 69130
    • Centre d'Education Motrice Henry Gormand
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Hôpital Nord
  • Lyon, France, 69005
    • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
  • Marseille, France, 13385
    • AP-HM Hopital de la Timone
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fifty-five children were included, 33 in the stable group and 22 in the intervention group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Children whose drooling was expected to remain relatively stable over 1 month
Intervention; Children receiving a treatment to reduce their drooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.

Collaborators and Investigators

• Sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
• Investigators: Principal Investigator: Emmanuelle Chaléat-Valayer, PhD, CMCR des Massues Croix rouge française

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Cerebral Palsy; Sialorrhea
• Other Study ID Numbers: DROOLING

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No