Cerebral PalsyNCT06497114
Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids
An observational study of Cerebral Palsy, run by Horus University at 1 site in Egypt.
Trial summary
HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ABILHAND-Kids questioner
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Oct 2024
- 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 4 to 18 years
- All sexes
- Child, Adult
Study population: cerebral palsy
Who may be able to join
- Parents of 100 children with CP will be recruited.
Who cannot join
- mental retardation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Horus University
Damietta
Horus University, 01144455581, ameeraa2011@gmail.com
About this study
Official title: Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids in a Sample of Egyptian Children With Cerebral Palsy.
HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy.
Read the detailed description
BACKGROUND Upper extremity functional impairment is a common problem in children with cerebral palsy. This has a significant impact on the children's manual ability which leads to activity limitation and participation restriction. The ABILHAND-Kids is a parent-reported outcome measure that quantifies the manual ability of children with CP. ABILHAND-Kids measures a child's ability to manage 21 daily activities that require the use of the upper limbs. The ABILHAND-Kids demonstrated very good measurement properties and is currently available in English, French, Dutch, Sweden, and Polish. It was also translated and adapted into the classic Arabic language in Saudi Arabia; in their study removal of two items resulted in a 19-item, valid, and reliable unidimensional scale meeting the requirement of the Rasch model without establishing measurement invariance between cultures. A linguistic adaptation is not sufficient to prove cross-cultural validity as item difficulties may vary across countries due to translation errors or cultural differences.
- Conditions
- Cerebral Palsy
- Being tested
- ABILHAND-Kids questioner
- Keywords
- hand function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABILHAND-Kids questionerOther
questioner
What is being measured
The primary outcome is the main question the study is designed to answer.
ABILHAND-Kids
parent-reported outcome measure that quantifies the manual ability of children with CP.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Yosry El-Dwiny, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497114
- Sponsor's protocol ID
- P.T.REC/012/004994
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids in a Sample of Egyptian Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06497114
- Acronym / sponsor ID
- P.T.REC/012/004994
- Conditions
- Cerebral Palsy
- Keywords
- hand function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy.
Detailed description
BACKGROUND Upper extremity functional impairment is a common problem in children with cerebral palsy. This has a significant impact on the children's manual ability which leads to activity limitation and participation restriction. The ABILHAND-Kids is a parent-reported outcome measure that quantifies the manual ability of children with CP. ABILHAND-Kids measures a child's ability to manage 21 daily activities that require the use of the upper limbs. The ABILHAND-Kids demonstrated very good measurement properties and is currently available in English, French, Dutch, Sweden, and Polish. It was also translated and adapted into the classic Arabic language in Saudi Arabia; in their study removal of two items resulted in a 19-item, valid, and reliable unidimensional scale meeting the requirement of the Rasch model without establishing measurement invariance between cultures. A linguistic adaptation is not sufficient to prove cross-cultural validity as item difficulties may vary across countries due to translation errors or cultural differences.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- cerebral palsy
Key inclusion criteria (1 listed)
- Parents of 100 children with CP will be recruited.
Key exclusion criteria (1 listed)
- mental retardation
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 |
|---|---|---|
| ABILHAND-Kids questionerquestioner | Other | – |
Primary outcome
ABILHAND-Kids
Time frame: 4 months
parent-reported outcome measure that quantifies the manual ability of children with CP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- 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.
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, run by Horus University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Yosry EL-Dwiny, lecturer (01287081914, ameeraa2011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABILHAND-Kids (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.