<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500782</url>
  </required_header>
  <id_info>
    <org_study_id>S62306</org_study_id>
    <nct_id>NCT04500782</nct_id>
  </id_info>
  <brief_title>Reliability and Validity of the Dutch Language Version of the CFCS-NL and the VSS-NL in Flanders, Belgium</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to determine the reliability and validity of the CFCS-NL and VSS-NL (both&#xD;
      speech and language-related classification scales for children with cerebral palsy) for&#xD;
      Flanders so they can be implemented within the CP-referencecentre at UZ Leuven, amongst the&#xD;
      classification scales that are already being used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Within the CP-referencecentre, the gross motor (GMFCS), fine motor (MACS) and swallowing&#xD;
      (EDACS) skills have of children witch cerebral palsy (CP) have long been classified. In the&#xD;
      speech and language pathology field, the Communication Function Classification Scale (CFCS)&#xD;
      and the Viking Speech Scale (VSS) were recently developed. The CFCS maps communication as a&#xD;
      whole and is a five-point scale. The CFCS is analogous to the aforementioned scales. The VSS&#xD;
      focuses on speech intelligibility and is a four-point scale.&#xD;
&#xD;
      This research is based on determining the reliability and validity of the above scales for&#xD;
      Flanders so that they can be implemented within the CP-referencecentre. In addition, the&#xD;
      mutual relationship between the scales and the relationship between the CFCS-NL and the other&#xD;
      classification scales for CP (GMFCS, MACS &amp; EDACS) will be determined. The VSS will also be&#xD;
      translated into Dutch beforehand, this is a collaboration with the VU University Amsterdam&#xD;
      (dr. Joke Geytenbeek).&#xD;
&#xD;
      The study is a cross-sectional study. The patients (n = 20) will be recruited during the&#xD;
      consultations at the CP-referencecentre between February 1, 2019 and April 30, 2019. The&#xD;
      selection criteria consist of: diagnosis of CP, age of 4 t.e.m. 10 years, single language&#xD;
      education in Dutch, no diagnosis of ASD and a signed Informed Consent Form.&#xD;
&#xD;
      A questionnaire bundle will be given to the parents of the participating patients (completion&#xD;
      time approx. 30 to 45 minutes). This includes a few questionnaires about characteristics of&#xD;
      the child / filler, two questionnaires about the social communication skills and the social&#xD;
      interaction skills of the child, and the CFCS and VSS scales which the parents have to score.&#xD;
      This questionnaire bundle (with the exception of the questionnaires concerning social&#xD;
      communication skills and social interaction skills) will also be given to the child's teacher&#xD;
      and a treating paramedic. In addition, an appointment will also be made at the patients house&#xD;
      where a video recording (2x15min) will be made in which the child interacts with a trusted&#xD;
      person and an untrusted person (the researcher) so that the CFCS- NL and the VSS-NL scores of&#xD;
      the child can be determined by the student and the speech therapists of the&#xD;
      CP-referencecentre. During that appointment one of the parents will also be interviewed using&#xD;
      the subdomain &quot;Social Functioning&quot; of the PEDI-NL.&#xD;
&#xD;
      After data collection, a quantitative data analysis is performed to obtain an answer to the&#xD;
      research questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reliability and validity of the CFCS-NL and the VSS-NL</measure>
    <time_frame>The scores will be collected over a timeframe of 5 months (may - september).</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between CFCS-NL and the VSS-NL</measure>
    <time_frame>The scores will be collected over a timeframe of 5 months (may - september).</time_frame>
    <description>The correlation will be measured using a Spearmans Rho.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between CFCS-NL, GMFCS, MACS and EDACS.</measure>
    <time_frame>The scores will be collected over a timeframe of 5 months (may - september).</time_frame>
    <description>The correlation will be measured using a Spearmans Rho.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Communication</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Group of patients with CP aged 4 to 10 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation at home.</intervention_name>
    <description>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, &amp; 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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cerebral Palsy (all CP-subtypes)&#xD;
&#xD;
          -  GMFCS I-V&#xD;
&#xD;
          -  age 4 - 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bi- or multilinguism&#xD;
&#xD;
          -  Diagnosis of autism&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cerebral Palsy&#xD;
&#xD;
          -  GMFCS I-V&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bi- or multilinguism&#xD;
&#xD;
          -  Diagnosis of autism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Els Ortibus, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven/ KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven/KU Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Berument SK, Rutter M, Lord C, Pickles A, Bailey A. Autism screening questionnaire: diagnostic validity. Br J Psychiatry. 1999 Nov;175:444-51. doi: 10.1192/bjp.175.5.444.</citation>
    <PMID>10789276</PMID>
  </reference>
  <reference>
    <citation>Eliasson AC, Krumlinde-Sundholm L, Rosblad 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. doi: 10.1017/S0012162206001162.</citation>
    <PMID>16780622</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/0895-4356(93)90142-n.</citation>
    <PMID>8263569</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21707596</PMID>
  </reference>
  <reference>
    <citation>Ostensjo S, Bjorbaekmo W, Carlberg EB, Vollestad 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. doi: 10.1080/09638280500212013.</citation>
    <PMID>16513582</PMID>
  </reference>
  <reference>
    <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. doi: 10.1111/j.1469-8749.1997.tb07414.x.</citation>
    <PMID>9183258</PMID>
  </reference>
  <reference>
    <citation>Pennington L, Virella D, Mjoen T, da Graca 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.</citation>
    <PMID>23891732</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17370477</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27366828</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24344767</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26136153</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CFCS</keyword>
  <keyword>VSS</keyword>
  <keyword>Cerebral Palsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500782
org study id: S62306
nct id: NCT04500782
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: 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).
description: 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.
measure: Correlation between CFCS-NL and the VSS-NL
time frame: The scores will be collected over a timeframe of 5 months (may - september).
description: The correlation will be measured using a Spearmans Rho.
measure: Correlation between CFCS-NL, GMFCS, MACS and EDACS.
time frame: The scores will be collected over a timeframe of 5 months (may - september).
description: The correlation will be measured using a Spearmans Rho.
arm group label: Patients
description: Group of patients with CP aged 4 to 10 years.
intervention type: Other
intervention name: Observation at home.
description: 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.
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Els Ortibus, Phd
role: Principal Investigator
affiliation: UZ Leuven/ KU Leuven
facility: 
country: Belgium
citation: Berument SK, Rutter M, Lord C, Pickles A, Bailey A. Autism screening questionnaire: diagnostic validity. Br J Psychiatry. 1999 Nov;175:444-51. doi: 10.1192/bjp.175.5.444.
PMID: 10789276
citation: Eliasson AC, Krumlinde-Sundholm L, Rosblad 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. doi: 10.1017/S0012162206001162.
PMID: 16780622
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. doi: 10.1016/0895-4356(93)90142-n.
PMID: 8263569
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.
PMID: 21707596
citation: Ostensjo S, Bjorbaekmo W, Carlberg EB, Vollestad 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. doi: 10.1080/09638280500212013.
PMID: 16513582
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. doi: 10.1111/j.1469-8749.1997.tb07414.x.
PMID: 9183258
citation: Pennington L, Virella D, Mjoen T, da Graca 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.
PMID: 23891732
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.
PMID: 17370477
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.
PMID: 27366828
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.
PMID: 24344767
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.
PMID: 26136153
responsible party type: Sponsor
mesh term: Cerebral Palsy
sharing ipd: No