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.
1 other identifier
observational
55
1 country
6
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedJune 14, 2019
May 1, 2019
2.9 years
May 13, 2019
June 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 Arms (2)
Control
Children whose drooling was expected to remain relatively stable over 1 month
Intervention
Children receiving a treatment to reduce their drooling
Eligibility Criteria
Fifty-five children were included, 33 in the stable group and 22 in the intervention group.
You may qualify if:
- 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
You may not qualify if:
- No clear understanding of french language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Centre d'Education Motrice Jean-Marie Arnion - Odynéo
Dommartin, 69380, France
Centre d'Education Motrice Henry Gormand
Écully, 69130, France
Centre Hospitalier Universitaire Hôpital Nord
La Tronche, 38700, France
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69005, France
AP-HM Hôpital de la Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuelle Chaléat-Valayer, PhD
CMCR des Massues Croix rouge française
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
June 14, 2019
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
June 14, 2019
Record last verified: 2019-05