Cerebral PalsyNCT06407908
Urdu Translation Of Pediatric Version Of Eating Assessment Tool
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among… Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 28 Jun 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The sample size is 42.
Who may be able to join
- Parents of children diagnosed with eating disorders
- Age from 3 to 15 years
Who cannot join
- Parents with children Unable to understand the questionnaire
- Parents with children who have Intellectual disability and any organic type of incontinence, neurological or anatomical problems
- Parents with who have children Severe cognitive decline or dementia
- Parents with children cannot understand Urdu.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Urdu Translation and Psychoprometric Properties Of Pediatric Version Of Eating Assessment Tool
Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among infants born prematurely, with low birth weight, and with complex medical disorders. The Eating Assessment Tool (EAT-10), consisting of 10 items, was first developed for infant patients.
(PEDI-EAT-10) will be translated into Urdu language by using forward backwards translation method. Two bilingual speakers expert in both Urdu and English languages will assist the researcher in the forward translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.
Read the detailed description
A mix method approach will be applied
- Forward translation
- Reconciliation of items
- Backward translation
- Review of forward and backward translation
- Pre-testing (cognitive interviewing)
- Validation study The process of translation followed the guidelines in the translation manual. Translators translate the pediatric version of eating assessment tool (Pedi-EAT-10), independently from each other into the Urdu language considering the following guidelines: using natural language acceptable to the broader public, performing a clear, simple, and understandable translation, avoiding lengthy and complicated sentences. This will be followed by a backward translation to ensure that the content, from the conceptual point of view, had not been modified in the translation. A native English translator was requested to carry out the back-translation, and all discrepancies were identified and corrected. To show whether all items are easily understood and acceptable to the patients, pretesting the final translated questionnaire will be conducted by administering it to patients with a varying education level. The questions that were not easily understood were discussed and redrafted by a panel of researchers until all interviewees understood all items.
- Conditions
- Cerebral Palsy
- Keywords
- validation, translation, eating disorder, PEDI-EAT-10
- Medical subject headings
- Cerebral Palsy, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Version of the Eating Assessment Tool (Pedi-EAT-10)
This resource is essential for determining how these obstacles affect a child's health and food consumption. The pediatric version is specially designed to evaluate a child's eating and swallowing skills, taking into consideration their specific developmental and physiological needs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 May 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Ahsan, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407908
- Sponsor's protocol ID
- REC/RCR&AHS/23/0788
- Status last verified
- Aug 2024
- First submitted
- 6 May 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
PubMed 20730626
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation and Psychoprometric Properties Of Pediatric Version Of Eating Assessment Tool
- ClinicalTrials.gov ID
- NCT06407908
- Acronym / sponsor ID
- REC/RCR&AHS/23/0788
- Conditions
- Cerebral Palsy
- Keywords
- validation, translation, eating disorder, PEDI-EAT-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 9 May 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.
Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among infants born prematurely, with low birth weight, and with complex medical disorders. The Eating Assessment Tool (EAT-10), consisting of 10 items, was first developed for infant patients.
(PEDI-EAT-10) will be translated into Urdu language by using forward backwards translation method. Two bilingual speakers expert in both Urdu and English languages will assist the researcher in the forward translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.
Detailed description
A mix method approach will be applied
- Forward translation
- Reconciliation of items
- Backward translation
- Review of forward and backward translation
- Pre-testing (cognitive interviewing)
- Validation study The process of translation followed the guidelines in the translation manual. Translators translate the pediatric version of eating assessment tool (Pedi-EAT-10), independently from each other into the Urdu language considering the following guidelines: using natural language acceptable to the broader public, performing a clear, simple, and understandable translation, avoiding lengthy and complicated sentences. This will be followed by a backward translation to ensure that the content, from the conceptual point of view, had not been modified in the translation. A native English translator was requested to carry out the back-translation, and all discrepancies were identified and corrected. To show whether all items are easily understood and acceptable to the patients, pretesting the final translated questionnaire will be conducted by administering it to patients with a varying education level. The questions that were not easily understood were discussed and redrafted by a panel of researchers until all interviewees understood all items.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The sample size is 42.
Key inclusion criteria (2 listed)
- Parents of children diagnosed with eating disorders
- Age from 3 to 15 years
Key exclusion criteria (4 listed)
- Parents with children Unable to understand the questionnaire
- Parents with children who have Intellectual disability and any organic type of incontinence, neurological or anatomical problems
- Parents with who have children Severe cognitive decline or dementia
- Parents with children cannot understand Urdu.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pediatric Version of the Eating Assessment Tool (Pedi-EAT-10)
Time frame: 6 months
This resource is essential for determining how these obstacles affect a child's health and food consumption. The pediatric version is specially designed to evaluate a child's eating and swallowing skills, taking into consideration their specific developmental and physiological needs.
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 14 Aug 2024.
- Background: PubMed 20730626Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
- 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.
Fatima Ahsan, MS* principal investigator
Riphah International University
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 Riphah International University at 1 site in Pakistan.
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 2 inclusion and 4 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 14 Aug 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 Pakistan. 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?
Pediatric Version of the Eating Assessment Tool (Pedi-EAT-10) (time frame: 6 months). 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 NCT06407908, which also lists 1 linked publication.
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 14 Aug 2024.