- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03325842
Transcultural Validation of Activities Scale for Kids (ASK)
Transcultural Validation of Activities Scale for Kids (ASK):Estimate of the Reliability of the Italian Version in the Population With PCI
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
RE
-
Reggio Emilia, RE, Italy, 42100
- Arcispedale Santa Maria Nuova
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Italian nationality
Exclusion Criteria:
- moderate or severe cognitive impairment;
- linguistic barriers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cerebral palsy
ASKp will be submitted to children of 5 to 15 years with hemiplegia or diplegia due to Cerebral Palsy, with normal or slightly impaired cognitive level.
|
30 items questionnaire
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Healthy individuals
ASKp will be submitted to children of 5 to 15 years with typical development
|
30 items questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Split-half reliability analysis by alpha of Cronbach, one item out.
Time Frame: 1 day
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adriano Ferrari, MD, Arcispedale Santa Maria Nuova-IRCCS
Publications and helpful links
General Publications
- 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.
- Costi S, Filippi MC, Braglia L, Beccani L, Corradi I, Bruzzi E, Signorelli C, Pelosin E. Reliability and construct validity of the Activities Scale for Kids in Italian children with cerebral palsy. Disabil Rehabil. 2022 Oct;44(21):6445-6451. doi: 10.1080/09638288.2021.1966519. Epub 2021 Aug 20.
- Costi S, Mecugni D, Beccani L, Alboresi S, Bressi B, Paltrinieri S, Ferrari A, Pelosin E. Construct Validity of the Activities Scale for Kids Performance in Children with Cerebral Palsy: Brief Report. Dev Neurorehabil. 2020 Oct;23(7):474-477. doi: 10.1080/17518423.2020.1764649. Epub 2020 Jun 7.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASKp_PCI_UDGEE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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