Clinical trial NCT04500782: Reliability and Validity of the Dutch Language Version of the CFCS-NL and the VSS-NL in Flanders, Belgium
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Communication
Keywords: CFCS
VSS
Cerebral Palsy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2020-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Cerebral Palsy (all CP-subtypes)
* GMFCS I-V
* age 4 - 10 years

Exclusion Criteria:

* Bi- or multilinguism
* Diagnosis of autism

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 t.e.m. 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 child's 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.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* GMFCS I-V

Exclusion Criteria:

* Bi- or multilinguism
* Diagnosis of autism

Primary outcomes:
measure: Reliability and validity of the CFCS-NL and the VSS-NL
timeFrame: The scores will be collected over a timeframe of 5 months (may - september).
Secondary outcomes:
measure: Correlation between CFCS-NL and the VSS-NL
timeFrame: The scores will be collected over a timeframe of 5 months (may - september).
measure: Correlation between CFCS-NL, GMFCS, MACS and EDACS.
timeFrame: The scores will be collected over a timeframe of 5 months (may - september).
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven/KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven/ KU Leuven
name: Els Ortibus, Phd
role: PRINCIPAL_INVESTIGATOR
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