Validation 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)

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Drooling Mouth Diseases Nervous System Diseases Salivary Gland Diseases Sialorrhea Stomatognathic Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'Education Motrice Jean-Marie Arnion - Odynéo, Dommartin, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Jun 14, 2019
Registry last updated: Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed