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

NCT ID: NCT03986333

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Drooling

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Children whose drooling was expected to remain relatively stable over 1 month

No interventions assigned to this group

Intervention

Children receiving a treatment to reduce their drooling

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle Chaléat-Valayer, PhD

Role: PRINCIPAL_INVESTIGATOR

CMCR des Massues Croix rouge française

Locations

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Centre d'Education Motrice Jean-Marie Arnion - Odynéo

Dommartin, , France

Site Status

Centre d'Education Motrice Henry Gormand

Écully, , France

Site Status

Centre Hospitalier Universitaire Hôpital Nord

La Tronche, , France

Site Status

Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, , France

Site Status

AP-HM Hôpital de la Timone

Marseille, , France

Site Status

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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DROOLING

Identifier Type: -

Identifier Source: org_study_id

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