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

August 3, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven/KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Cerebral Palsy
  • GMFCS I-V

Exclusion Criteria:

  • Bi- or multilinguism
  • Diagnosis of autism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Group of patients with CP aged 4 to 10 years.
Other: Observation at home.
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.

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
Time Frame: The scores will be collected over a timeframe of 5 months (may - september).

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
Time Frame: The scores will be collected over a timeframe of 5 months (may - september).
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.
Time Frame: The scores will be collected over a timeframe of 5 months (may - september).
The correlation will be measured using a Spearmans Rho.
The scores will be collected over a timeframe of 5 months (may - september).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Investigators

  • Principal Investigator: Els Ortibus, Phd, UZ Leuven/ KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

June 25, 2020

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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