Transcultural Validation of Activities Scale for Kids (ASK)

Sponsor

University of Modena and Reggio Emilia (Other)

Overall Status

Completed

CT.gov ID

NCT03325842

Collaborator

Arcispedale Santa Maria Nuova-IRCCS (Other)

300

Enrollment

Location

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy and Healthy Individuals	Diagnostic Test: ASKp

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Transcultural Validation of Activities Scale for Kids (ASK):Estimate of the Reliability of the Italian Version in the Population With PCI

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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.	Diagnostic Test: ASKp 30 items questionnaire
Healthy individuals ASKp will be submitted to children of 5 to 15 years with typical development	Diagnostic Test: ASKp 30 items questionnaire

Arm

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.

Diagnostic Test: ASKp

30 items questionnaire

Healthy individuals

ASKp will be submitted to children of 5 to 15 years with typical development

Diagnostic Test: ASKp

30 items questionnaire

Outcome Measures

Primary Outcome Measures

Split-half reliability analysis by alpha of Cronbach, one item out. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Italian nationality

Exclusion Criteria:

moderate or severe cognitive impairment;
linguistic barriers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arcispedale Santa Maria Nuova	Reggio Emilia	RE	Italy	42100

Sponsors and Collaborators

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

Investigators

Principal Investigator: Adriano Ferrari, MD, Arcispedale Santa Maria Nuova-IRCCS

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Stefania Costi, Researcher in PT, University of Modena and Reggio Emilia

ClinicalTrials.gov Identifier:

NCT03325842

Other Study ID Numbers:

ASKp_PCI_UDGEE

First Posted:

Oct 30, 2017

Last Update Posted:

Oct 21, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stefania Costi, Researcher in PT, University of Modena and Reggio Emilia

Cross-cultural comparison

Disability evaluation

Self-assessment

Child

Adolescent

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Oct 21, 2021