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CompletedNCT05276869Updated Mar 11, 2022

Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns

An observational study in Burns, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Other
Enrollment
53
Ages
3 Years to 16 Years
Sex
All
01

Study 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 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
  1. First the weeFIM will undergo forward Arabic translation followed by English backward translation.
  2. Second the instrument will be adapted to Egyptian accent.
  3. 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.
  4. Last, statistical analysis for feasibility and reliability will be performed.
02

Conditions studied

  • Burns

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Keywords

  • WeeFIM instrument
  • functional independence
  • pediatric burns
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 53 is close to the median of 55 across 135 observational studies indexed under Burns.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-crossover
Time perspective
Other
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • group A

    from 3 to 7 years included 36 patients

    Other: WeeFIM instrument

  • group B

    from 8 to 16 years included 17 patients

    Other: WeeFIM instrument

Interventions

  • OtherWeeFIM instrument

    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 \[10\].

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline, after 2 weeks postburn.

  2. 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 \[19\].

    Time frame: Change from Baseline, after 2 weeks postburn.

07

Study locations

1 site
  • Faculty of Physical Therapy
    Giza, 11432, Egypt
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05276869
Lead sponsor
Cairo University
Responsible party
Eman Mohamed othman (professor, Cairo University) — Principal investigator
First posted
Mar 11, 2022
Start date
Sep 5, 2021
Primary completion
Jan 20, 2022
Completion
Feb 10, 2022
Last update
Mar 11, 2022

Study contacts

eman othman, PhD
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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