Reliability and Validity of the Dutch Language Version of the CFCS-NL and the VSS-NL in Flanders, Belgium

Study Overview
=================
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.

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

Conditions
-----------------
Cerebral Palsy, Communication

Intervention / Treatment
-----------------
* Other: Observation at home.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral Palsy GMFCS I-V Exclusion Criteria: Bi- or multilinguism Diagnosis of autism

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Group of patients with CP aged 4 to 10 years. | Other: Observation at home.<br>* An appointment will be made at home, first one of the parents will be interviewed using the 'Social Functioning' subdomain of the PEDI-NL (Ostensjo, Bjorbaekmo, Brogren Carlberg, & Vollestad, 2006) to determine the validity of the CFCS-NL and the VSS NL . This section contains some aspects that question the communication skills. The PEDI-NL was chosen as there is no gold standard to investigate functional communication in people with CP. Most standardized test and observational instruments only investigate language comprehension and / or language production and are furthermore developed for normally developing children. On the other hand, a video recording will be made in which the child interacts with a relative and an unknown person (the researcher) so that the CFCS-NL and VSS-score can be determined by the student and the speech therapists of the CP reference center.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and validity of the CFCS-NL and the VSS-NL | The inter-rater-reliability of the CFCS-NL and the VSS-NL (which are described above in the descriptive section) will be measured by comparing the classification scores given by the different groups of people who classified the child, using Cohen's Kappa. The validity of the CFCS-NL and the VSS-NL will be measured by comparing the scores with the total score on the section 'Social Functioning' of the PEDI-NL, using a Spearmans rho. | The scores will be collected over a timeframe of 5 months (may - september). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between CFCS-NL and the VSS-NL | The correlation will be measured using a Spearmans Rho. | The scores will be collected over a timeframe of 5 months (may - september). | 
| Correlation between CFCS-NL, GMFCS, MACS and EDACS. | The correlation will be measured using a Spearmans Rho. | The scores will be collected over a timeframe of 5 months (may - september). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CFCS, VSS, Cerebral Palsy