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Clinical Trials/NCT03986333
NCT03986333
Completed
Not Applicable

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

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française6 sites in 1 country55 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Enrollment
55
Locations
6
Primary Endpoint
Change in Drooling Impact Scale
Status
Completed
Last Updated
6 years ago

Overview

Brief 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)

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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(All groups : at inclusion)
  • Test-retest reliability(Control group : baseline and 1 month later)
  • Responsiveness to change(Intervention group : baseline and 1 month after treatment.)

Study Sites (6)

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