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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325842
Other study ID # ASKp_PCI_UDGEE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date December 31, 2020

Study information

Verified date October 2021
Source University of Modena and Reggio Emilia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Activities Scale for Kids performance (ASKp) is one of the few self-assessment questionnaires in pediatric rehabilitation that measures child perception in performance of daily routine activities. ASKp is composed of 30 questions designed to explore activities and participation in children and teenagers with musculoskeletal disorders. Scores assess level of physical ability, identify appropriate treatment and monitor changes over time. We recently undertook the cross-cultural validation to achieve a culturally adapted Italian version of ASKp: the Italian version is now to be tested on Italian children.


Description:

The purpose of the study isto test the psychometric properties of the Italian version of the ASKp assessment scale, in a representative sample of individuals with PCI. ASK p will be administered on a sample of individuals belonging to the population of children and / or adolescents with diplegia and hemiplegia as a consequence of PCI. We will perform comprehensive descriptive analysis of the data collected as well as the measurement of the degree of reliability of the Italian version of the scale. The aim is to obtain an estimate of ASKp reliability obtained through transcultural validation. Additionally, we will submit the ASKp on a control group of typical development children in order to test its ability to discriminate between different skill levels.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2020
Est. primary completion date February 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria: - Italian nationality Exclusion Criteria: - moderate or severe cognitive impairment; - linguistic barriers

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ASKp
30 items questionnaire

Locations

Country Name City State
Italy Arcispedale Santa Maria Nuova Reggio Emilia RE

Sponsors (2)

Lead Sponsor Collaborator
University of Modena and Reggio Emilia Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Fabbri L, Neviani R, Festini F, Costi S. Transcultural validation of Activities Scale for Kids (ASK): translation and pilot test. Acta Biomed. 2016 May 26;87 Suppl 2:70-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Split-half reliability analysis by alpha of Cronbach, one item out. A split-half reliability analysis will be performed by calculating the alpha of Cronbach by removing one item at a time. It will then be assessed which items lower the degree of internal reliability of the questionnaire. Items that reduce internal consistency will be eliminated and the final alpha will be calculated. For a group of children with PCI and for the control group a comprehensive descriptive analysis of the collected data will be performed, representing the distribution of scores obtained by age group. 1 day