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

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ClinicalTrials.gov Identifier: NCT03986333
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

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)

Condition or disease
Cerebral Palsy Drooling

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.


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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Control
Children whose drooling was expected to remain relatively stable over 1 month
Intervention
Children receiving a treatment to reduce their drooling



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fifty-five children were included, 33 in the stable group and 22 in the intervention group.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986333


Locations
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France
Centre d'Education Motrice Jean-Marie Arnion - Odynéo
Dommartin, France, 69380
Centre d'Education Motrice Henry Gormand
Ecully, France, 69130
Centre Hospitalier Universitaire Hôpital Nord
La Tronche, France, 38700
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, France, 69005
AP-HM Hôpital de la Timone
Marseille, France, 13385
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Investigators
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Principal Investigator: Emmanuelle Chaléat-Valayer, PhD CMCR des Massues Croix rouge française

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Responsible Party: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
ClinicalTrials.gov Identifier: NCT03986333     History of Changes
Other Study ID Numbers: DROOLING
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sialorrhea
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases