- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03986333
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dommartin, France, 69380
- Centre d'Education Motrice Jean-Marie Arnion - Odynéo
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Ecully, France, 69130
- Centre d'Education Motrice Henry Gormand
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La Tronche, France, 38700
- Centre Hospitalier Universitaire Hôpital Nord
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Lyon, France, 69005
- Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
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Marseille, France, 13385
- AP-HM Hopital de la Timone
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Nîmes, France, 30029
- Centre Hospitalier Universitaire de Nîmes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
Children whose drooling was expected to remain relatively stable over 1 month
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Intervention
Children receiving a treatment to reduce their drooling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Drooling Impact Scale
Time Frame: Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment
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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).
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Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internal consistency
Time Frame: All groups : at inclusion
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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.
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All groups : at inclusion
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Test-retest reliability
Time Frame: Control group : baseline and 1 month later
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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.
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Control group : baseline and 1 month later
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Responsiveness to change
Time Frame: Intervention group : baseline and 1 month after treatment.
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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).
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Intervention group : baseline and 1 month after treatment.
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Collaborators and Investigators
Investigators
- Principal Investigator: Emmanuelle Chaléat-Valayer, PhD, CMCR des Massues Croix rouge française
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DROOLING
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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