Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500782
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2020-06-30
Brief Title:
Reliability and Validity of the Dutch Language Version of the CFCS-NL and the VSS-NL in Flanders Belgium
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Reliability and Validity of the Dutch Language Version of the Communication Function Classification System CFCS-NL and the Viking Speech Scale VSS-NL in Flanders Belgium
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to determine the reliability and validity of the CFCS-NL and VSS-NL both speech and language-related classification scales for children with cerebral palsy for Flanders so they can be implemented within the CP-referencecentre at UZ Leuven amongst the classification scales that are already being used
Detailed Description:
Within the CP-referencecentre the gross motor GMFCS fine motor MACS and swallowing EDACS skills have of children witch cerebral palsy CP have long been classified In the speech and language pathology field the Communication Function Classification Scale CFCS and the Viking Speech Scale VSS were recently developed The CFCS maps communication as a whole and is a five-point scale The CFCS is analogous to the aforementioned scales The VSS focuses on speech intelligibility and is a four-point scale
This research is based on determining the reliability and validity of the above scales for Flanders so that they can be implemented within the CP-referencecentre In addition the mutual relationship between the scales and the relationship between the CFCS-NL and the other classification scales for CP GMFCS MACS EDACS will be determined The VSS will also be translated into Dutch beforehand this is a collaboration with the VU University Amsterdam dr Joke Geytenbeek
The study is a cross-sectional study The patients n 20 will be recruited during the consultations at the CP-referencecentre between February 1 2019 and April 30 2019 The selection criteria consist of diagnosis of CP age of 4 tem 10 years single language education in Dutch no diagnosis of ASD and a signed Informed Consent Form
A questionnaire bundle will be given to the parents of the participating patients completion time approx 30 to 45 minutes This includes a few questionnaires about characteristics of the child filler two questionnaires about the social communication skills and the social interaction skills of the child and the CFCS and VSS scales which the parents have to score This questionnaire bundle with the exception of the questionnaires concerning social communication skills and social interaction skills will also be given to the childs teacher and a treating paramedic In addition an appointment will also be made at the patients house where a video recording 2x15min will be made in which the child interacts with a trusted person and an untrusted person the researcher so that the CFCS- NL and the VSS-NL scores of the child can be determined by the student and the speech therapists of the CP-referencecentre During that appointment one of the parents will also be interviewed using the subdomain Social Functioning of the PEDI-NL
After data collection a quantitative data analysis is performed to obtain an answer to the research questions
This research is based on determining the reliability and validity of the above scales for Flanders so that they can be implemented within the CP-referencecentre In addition the mutual relationship between the scales and the relationship between the CFCS-NL and the other classification scales for CP GMFCS MACS EDACS will be determined The VSS will also be translated into Dutch beforehand this is a collaboration with the VU University Amsterdam dr Joke Geytenbeek
The study is a cross-sectional study The patients n 20 will be recruited during the consultations at the CP-referencecentre between February 1 2019 and April 30 2019 The selection criteria consist of diagnosis of CP age of 4 tem 10 years single language education in Dutch no diagnosis of ASD and a signed Informed Consent Form
A questionnaire bundle will be given to the parents of the participating patients completion time approx 30 to 45 minutes This includes a few questionnaires about characteristics of the child filler two questionnaires about the social communication skills and the social interaction skills of the child and the CFCS and VSS scales which the parents have to score This questionnaire bundle with the exception of the questionnaires concerning social communication skills and social interaction skills will also be given to the childs teacher and a treating paramedic In addition an appointment will also be made at the patients house where a video recording 2x15min will be made in which the child interacts with a trusted person and an untrusted person the researcher so that the CFCS- NL and the VSS-NL scores of the child can be determined by the student and the speech therapists of the CP-referencecentre During that appointment one of the parents will also be interviewed using the subdomain Social Functioning of the PEDI-NL
After data collection a quantitative data analysis is performed to obtain an answer to the research questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None