An observational study in Cerebral Palsy and Drooling, sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Completed at 6 sites in France. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Observational
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)
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 55 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
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Fifty-five children were included, 33 in the stable group and 22 in the intervention group.
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Exclusion Criteria:
Children whose drooling was expected to remain relatively stable over 1 month
Children receiving a treatment to reduce their drooling
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).
Time frame: Control group : baseline and 1 month later. Intervention group : baseline and 1 month after treatment
Internal consistency
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.
Time frame: All groups : at inclusion
Test-retest reliability
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.
Time frame: Control group : baseline and 1 month later
Responsiveness to change
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).
Time frame: Intervention group : baseline and 1 month after treatment.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française