BurnsNCT05276869
Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
An observational study of Burns, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: Is to test the feasibility and the reliability of the Arabic version of wee functional independence measure (weeFIM) in children with healed burns. BACKGROUND: Since kids are the most influenced casualty of burn and they may have lasting disabilities because of this harm, consequently they should have care in… Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Burns
- What is being tested?
- WeeFIM instrument
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2021to 10 Feb 2022
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Enrollment of participants was done for all children who meet the inclusion criteria. The demographic details about each parent and child were noted, and screening was done for adherence to inclusion and exclusion criteria. The tool was given to all children aged 3 years to 16 years who were hospitalized in one of the two places for more than two weeks after the burn.
Who may be able to join
- patients who had a healed burn with an age from 3 years to 16 years.
- All participants or their parents had to be able to read, write, and speak Arabic
- They had passed two weeks post-burn.
Who cannot join
- Children with a history of neurological impairment or orthopedic surgery to the limbs or spine.
- those with severe burns (4th degree burns), extensive burn is >60%.
- infected burn wounds.
- other medical conditions that might impair physical performance.
- children with any medical illness present in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Arabic Version of WeeFIM Instrument Reliable and Feasible Enough to Measure Functional Independence in Egyptian Children With Burns?
PURPOSE:
Is to test the feasibility and the reliability of the Arabic version of wee functional independence measure (weeFIM) in children with healed burns.
Read more
BACKGROUND:
Since kids are the most influenced casualty of burn and they may have lasting disabilities because of this harm, consequently they should have care in evaluation and treatment procedure in exploration.
There are two main instruments that can be utilized to evaluate the function of young kid's which are the Functional independence measure for kids (WeeFIM) instrument and the Pediatric evaluation of disability inventory (PEDI) instrument.
Therefore, the aim of this study was to investigate the reliability and feasibility of the Arabic version of the WeeFIM instrument in kids from 3 years to 16 years of age with healed burn.
HYPOTHESES:
Arabic version of WeeFIM questionnaire will not be feasible and reliable to measure and report the functional outcome of kids with healed burns.
RESEARCH QUESTION:
Is the Arabic version of weeFIM instrument feasible and reliable enough to measure and report the functional outcome of children with healed burns?
Read the detailed description
- First the weeFIM will undergo forward Arabic translation followed by English backward translation.
- Second the instrument will be adapted to Egyptian accent.
- Third the process of filling of questionnaire will be applied. It will be either parent filled or child filled. And will be performed by interview for illiterate patients.
- Last, statistical analysis for feasibility and reliability will be performed.
- Conditions
- Burns
- Being tested
- WeeFIM instrument
- Keywords
- WeeFIM instrument, functional independence, pediatric burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeeFIM instrumentOther
In a formative setting, the WeeFIM tool examines functional independence in kids aged 6 months to 7 years old. It can also be used with children over the age of 7 who show functional ability. The instrument may be controlled by observational data or a meeting, and it takes 15 to 20 minutes to create [10].
| Study group | Role | What they receive |
|---|---|---|
| group A | from 3 to 7 years included 36 patients Receives: Other: WeeFIM instrument | |
| group B | from 8 to 16 years included 17 patients Receives: Other: WeeFIM instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
The reliability of the Arabic version of the WeeFIM instrument was assessed by a test-retest procedure. First, the researcher collected a random sample of participants. Second, the researchers explained the procedure to the participants. Third, the researchers explained the items of the questionnaire to the participants. Fourth, the participants were asked to fill the scale with score-1. Fifth, one week apart, they were asked to re-fill the scale with score-2. Sixth, test-retest reliability was analysed by using Pearson Correlation Coefficient (PCC) and internal consistency was measured by using Cronbach's alpha Coefficient.
Measured: Change from Baseline, after 2 weeks postburn.
Content validity
In this study, content validity (items' relevance and adequacy for the intended use) of the Arabic version of the WeeFIM instrument was assessed. Content validity deals with the extent to which an instrument reflects the meaningful elements of the content without extraneous elements [19].
Measured: Change from Baseline, after 2 weeks postburn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start5 Sep 2021
- Primary completion20 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case crossover
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed othman, Cairo University
- Investigators
- eman othman, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276869
- Sponsor's protocol ID
- 012/003578
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Arabic Version of WeeFIM Instrument Reliable and Feasible Enough to Measure Functional Independence in Egyptian Children With Burns?
- ClinicalTrials.gov ID
- NCT05276869
- Acronym / sponsor ID
- 012/003578
- Conditions
- Burns
- Keywords
- WeeFIM instrument, functional independence, pediatric burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 11 Mar 2022 (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.
PURPOSE:
Is to test the feasibility and the reliability of the Arabic version of wee functional independence measure (weeFIM) in children with healed burns.
BACKGROUND:
Since kids are the most influenced casualty of burn and they may have lasting disabilities because of this harm, consequently they should have care in evaluation and treatment procedure in exploration.
There are two main instruments that can be utilized to evaluate the function of young kid's which are the Functional independence measure for kids (WeeFIM) instrument and the Pediatric evaluation of disability inventory (PEDI) instrument.
Therefore, the aim of this study was to investigate the reliability and feasibility of the Arabic version of the WeeFIM instrument in kids from 3 years to 16 years of age with healed burn.
HYPOTHESES:
Arabic version of WeeFIM questionnaire will not be feasible and reliable to measure and report the functional outcome of kids with healed burns.
RESEARCH QUESTION:
Is the Arabic version of weeFIM instrument feasible and reliable enough to measure and report the functional outcome of children with healed burns?
Detailed description
- First the weeFIM will undergo forward Arabic translation followed by English backward translation.
- Second the instrument will be adapted to Egyptian accent.
- Third the process of filling of questionnaire will be applied. It will be either parent filled or child filled. And will be performed by interview for illiterate patients.
- Last, statistical analysis for feasibility and reliability will be performed.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: WeeFIM instrumentfrom 3 to 7 years included 36 patients |
| group B | – | Other: WeeFIM instrumentfrom 8 to 16 years included 17 patients |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Enrollment of participants was done for all children who meet the inclusion criteria. The demographic details about each parent and child were noted, and screening was done for adherence to inclusion and exclusion criteria. The tool was given to all children aged 3 years to 16 years who were hospitalized in one of the two places for more than two weeks after the burn.
Key inclusion criteria (3 listed)
- patients who had a healed burn with an age from 3 years to 16 years.
- All participants or their parents had to be able to read, write, and speak Arabic
- They had passed two weeks post-burn.
Key exclusion criteria (5 listed)
- Children with a history of neurological impairment or orthopedic surgery to the limbs or spine.
- those with severe burns (4th degree burns), extensive burn is >60%.
- infected burn wounds.
- other medical conditions that might impair physical performance.
- children with any medical illness present in the previous month.
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 |
|---|---|---|
| WeeFIM instrumentIn a formative setting, the WeeFIM tool examines functional independence in kids aged 6 months to 7 years old. It can also be used with children over the age of 7 who show functional ability. The instrument may be controlled by observational data or a meeting, and it takes 15 to 20 minutes to create [10]. | Other | group A, group B |
Primary outcome
Reliability
Time frame: Change from Baseline, after 2 weeks postburn.
The reliability of the Arabic version of the WeeFIM instrument was assessed by a test-retest procedure. First, the researcher collected a random sample of participants. Second, the researchers explained the procedure to the participants. Third, the researchers explained the items of the questionnaire to the participants. Fourth, the participants were asked to fill the scale with score-1. Fifth, one week apart, they were asked to re-fill the scale with score-2. Sixth, test-retest reliability was analysed by using Pearson Correlation Coefficient (PCC) and internal consistency was measured by using Cronbach's alpha Coefficient.
Content validity
Time frame: Change from Baseline, after 2 weeks postburn.
In this study, content validity (items' relevance and adequacy for the intended use) of the Arabic version of the WeeFIM instrument was assessed. Content validity deals with the extent to which an instrument reflects the meaningful elements of the content without extraneous elements [19].
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 11 Mar 2022.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
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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.
eman othman, PhD study director
Cairo 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 Burns, run by Cairo 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 3 inclusion and 5 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 11 Mar 2022. 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?
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?
Reliability (time frame: Change from Baseline, after 2 weeks postburn.). The study lists 2 primary outcomes in all. 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 Mar 2022.