Condition or disease |
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Cerebral Palsy Drooling |
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 : | 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 |
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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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 |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Emmanuelle Chaléat-Valayer, PhD | CMCR des Massues Croix rouge française |
Tracking Information | |||||
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First Submitted Date | May 13, 2019 | ||||
First Posted Date | June 14, 2019 | ||||
Last Update Posted Date | June 14, 2019 | ||||
Actual Study Start Date | January 2015 | ||||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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).
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population | ||||
Official Title | Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population. | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Fifty-five children were included, 33 in the stable group and 22 in the intervention group. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
55 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | December 2018 | ||||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 18 Years (Child, Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03986333 | ||||
Other Study ID Numbers | DROOLING | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française | ||||
Study Sponsor | Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française | ||||
Verification Date | May 2019 |