Cerebral Palsy and Healthy IndividualsNCT03325842
Transcultural Validation of Activities Scale for Kids (ASK)
An observational study of Cerebral Palsy and Healthy Individuals, run by University of Modena and Reggio Emilia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy and Healthy Individuals
- What is being tested?
- ASKp
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children or adolescents and children or adolescents with cerebral palsy
Who may be able to join
- Italian nationality
Who cannot join
- moderate or severe cognitive impairment;
- linguistic barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcultural Validation of Activities Scale for Kids (ASK):Estimate of the Reliability of the Italian Version in the Population With PCI
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.
Read the 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.
- Conditions
- Cerebral Palsy and Healthy Individuals
- Being tested
- ASKp
- Keywords
- Cross-cultural comparison, Disability evaluation, Self-assessment, Child, Adolescent
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKpDiagnostic test
30 items questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ASKp | |
| Healthy individuals | ASKp will be submitted to children of 5 to 15 years with typical development Receives: Diagnostic Test: ASKp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startJan 2017
- Primary completion29 Feb 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy and Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Principal investigator, Stefania Costi, University of Modena and Reggio Emilia
- Investigators
- Adriano Ferrari, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325842
- Sponsor's protocol ID
- ASKp_PCI_UDGEE
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2017
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27240035Costi 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.
PubMed 34415225Costi 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.
PubMed 32508188
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation of Activities Scale for Kids (ASK):Estimate of the Reliability of the Italian Version in the Population With PCI
- ClinicalTrials.gov ID
- NCT03325842
- Acronym / sponsor ID
- ASKp_PCI_UDGEE
- Conditions
- Cerebral Palsy and Healthy Individuals
- Keywords
- Cross-cultural comparison, Disability evaluation, Self-assessment, Child, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Jan 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral palsy | – | Diagnostic Test: ASKpASKp 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. |
| Healthy individuals | – | Diagnostic Test: ASKpASKp will be submitted to children of 5 to 15 years with typical development |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children or adolescents and children or adolescents with cerebral palsy
Key inclusion criteria (1 listed)
- Italian nationality
Key exclusion criteria (2 listed)
- moderate or severe cognitive impairment;
- linguistic barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKp30 items questionnaire | Diagnostic test | Cerebral palsy, Healthy individuals |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 27240035Fabbri 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.
- Derived from this study: PubMed 34415225Costi 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.
- Derived from this study: PubMed 32508188Costi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriano Ferrari, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Healthy Individuals, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Split-half reliability analysis by alpha of Cronbach, one item out. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.