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出境医 / 临床实验 / Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort
Control
Children whose drooling was expected to remain relatively stable over 1 month
Intervention
Children receiving a treatment to reduce their drooling
Outcome Measures
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).


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
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
 (submitted: June 13, 2019)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 13, 2019)
  • 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.
  • 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.
  • 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).
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
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
  • Cerebral Palsy
  • Drooling
Intervention Not Provided
Study Groups/Cohorts
  • Control
    Children whose drooling was expected to remain relatively stable over 1 month
  • Intervention
    Children receiving a treatment to reduce their drooling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2019)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Emmanuelle Chaléat-Valayer, PhD CMCR des Massues Croix rouge française
PRS Account Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Verification Date May 2019