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

March 9, 2022 updated by: Eman Mohamed othman, Cairo University

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.

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11432
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
from 3 to 7 years included 36 patients
Other: WeeFIM 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].
group B
from 8 to 16 years included 17 patients
Other: WeeFIM 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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline, after 2 weeks postburn.
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].
Change from Baseline, after 2 weeks postburn.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: eman othman, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2021

Primary Completion (ACTUAL)

January 20, 2022

Study Completion (ACTUAL)

February 10, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (ACTUAL)

March 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/003578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

1 year after publication

IPD Sharing Access Criteria

the criteria will be assessed by the publication of the trial in an international journals.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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