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

Burns Clinical Trial

Official title:

Is Arabic Version of WeeFIM Instrument Reliable and Feasible Enough to Measure Functional Independence in Egyptian Children With Burns?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276869
• Other study ID #: 012/003578
• Status: Completed
• Start date: September 5, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 10, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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].

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline, after 2 weeks postburn.
Primary	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].	Change from Baseline, after 2 weeks postburn.