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临床试验/NCT04500782
NCT04500782已完成不适用

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

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Reliability and validity of the CFCS-NL and the VSS-NL

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cerebral Palsy
  • GMFCS I-V

排除标准

  • Bi- or multilinguism
  • Diagnosis of autism

结局指标

主要结局

Reliability and validity of the CFCS-NL and the VSS-NL

时间窗: 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.

次要结局

  • Correlation between CFCS-NL and the VSS-NL(The scores will be collected over a timeframe of 5 months (may - september).)
  • Correlation between CFCS-NL, GMFCS, MACS and EDACS.(The scores will be collected over a timeframe of 5 months (may - september).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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