NCT05276869

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

February 28, 2022

Last Update Submit

March 9, 2022

Conditions

Keywords

WeeFIM instrumentfunctional independencepediatric burns

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

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

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 Agroup B

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • eman othman, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 11, 2022

Study Start

September 5, 2021

Primary Completion

January 20, 2022

Study Completion

February 10, 2022

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF
Time Frame
1 year after publication
Access Criteria
the criteria will be assessed by the publication of the trial in an international journals.

Locations