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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500782
• Other study ID #: S62306
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: June 25, 2020

Study information

• Verified date: June 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 25, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Cerebral Palsy

• GMFCS I-V

Exclusion Criteria:

• Bi- or multilinguism

• Diagnosis of autism

Related Conditions & MeSH terms

• Cerebral Palsy
• Communication

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven/KU Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (11)

Berument SK, Rutter M, Lord C, Pickles A, Bailey A. Autism screening questionnaire: diagnostic validity. Br J Psychiatry. 1999 Nov;175:444-51. — View Citation

Eliasson AC, Krumlinde-Sundholm L, Rösblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. — View Citation

Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. Review. — View Citation

Hidecker MJ, Paneth N, Rosenbaum PL, Kent RD, Lillie J, Eulenberg JB, Chester K Jr, Johnson B, Michalsen L, Evatt M, Taylor K. Developing and validating the Communication Function Classification System for individuals with cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):704-10. doi: 10.1111/j.1469-8749.2011.03996.x. Epub 2011 Jun 27. — View Citation

Østensjø S, Bjorbaekmo W, Carlberg EB, Vøllestad NK. Assessment of everyday functioning in young children with disabilities: an ICF-based analysis of concepts and content of the Pediatric Evaluation of Disability Inventory (PEDI). Disabil Rehabil. 2006 Apr 30;28(8):489-504. — View Citation

Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. — View Citation

Pennington L, Virella D, Mjøen T, da Graça Andrada M, Murray J, Colver A, Himmelmann K, Rackauskaite G, Greitane A, Prasauskiene A, Andersen G, de la Cruz J. Development of The Viking Speech Scale to classify the speech of children with cerebral palsy. Res Dev Disabil. 2013 Oct;34(10):3202-10. doi: 10.1016/j.ridd.2013.06.035. Epub 2013 Jul 24. — View Citation

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum in: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation

Scime NV, Bartlett DJ, Brunton LK, Palisano RJ. Parents' Experiences and Perceptions when Classifying their Children with Cerebral Palsy: Recommendations for Service Providers. Phys Occup Ther Pediatr. 2017 Aug;37(3):252-267. doi: 10.1080/01942638.2016.1185505. Epub 2016 Jul 1. — View Citation

Sellers D, Mandy A, Pennington L, Hankins M, Morris C. Development and reliability of a system to classify the eating and drinking ability of people with cerebral palsy. Dev Med Child Neurol. 2014 Mar;56(3):245-51. doi: 10.1111/dmcn.12352. Epub 2013 Dec 18. — View Citation

Vander Zwart KE, Geytenbeek JJ, de Kleijn M, Oostrom KJ, Gorter JW, Hidecker MJ, Vermeulen RJ. Reliability of the Dutch-language version of the Communication Function Classification System and its association with language comprehension and method of communication. Dev Med Child Neurol. 2016 Feb;58(2):180-8. doi: 10.1111/dmcn.12839. Epub 2015 Jul 1. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).