Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 10:25 PM
Study NCT ID:
NCT05276869
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability', 'timeFrame': 'Change from Baseline, after 2 weeks postburn.', 'description': "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."}, {'measure': 'Content validity', 'timeFrame': 'Change from Baseline, after 2 weeks postburn.', 'description': "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\\]."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WeeFIM instrument', 'functional independence', 'pediatric burns'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': "PURPOSE:\n\nIs to test the feasibility and the reliability of the Arabic version of wee functional independence measure (weeFIM) in children with healed burns.\n\nBACKGROUND:\n\nSince 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.\n\nThere 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.\n\nTherefore, 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.\n\nHYPOTHESES:\n\nArabic version of WeeFIM questionnaire will not be feasible and reliable to measure and report the functional outcome of kids with healed burns.\n\nRESEARCH QUESTION:\n\nIs the Arabic version of weeFIM instrument feasible and reliable enough to measure and report the functional outcome of children with healed burns?", 'detailedDescription': '1. First the weeFIM will undergo forward Arabic translation followed by English backward translation.\n2. Second the instrument will be adapted to Egyptian accent.\n3. 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.\n4. Last, statistical analysis for feasibility and reliability will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who had a healed burn with an age from 3 years to 16 years.\n* All participants or their parents had to be able to read, write, and speak Arabic\n* They had passed two weeks post-burn.\n\nExclusion Criteria:\n\n* Children with a history of neurological impairment or orthopedic surgery to the limbs or spine.\n* those with severe burns (4th degree burns), extensive burn is \\>60%.\n* infected burn wounds.\n* other medical conditions that might impair physical performance.\n* children with any medical illness present in the previous month.'}, 'identificationModule': {'nctId': 'NCT05276869', 'briefTitle': 'Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Is Arabic Version of WeeFIM Instrument Reliable and Feasible Enough to Measure Functional Independence in Egyptian Children With Burns?', 'orgStudyIdInfo': {'id': '012/003578'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'from 3 to 7 years included 36 patients', 'interventionNames': ['Other: WeeFIM instrument']}, {'label': 'group B', 'description': 'from 8 to 16 years included 17 patients', 'interventionNames': ['Other: WeeFIM instrument']}], 'interventions': [{'name': 'WeeFIM instrument', 'type': 'OTHER', 'description': '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\\].', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'eman othman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'timeFrame': '1 year after publication', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'the criteria will be assessed by the publication of the trial in an international journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Eman Mohamed othman', 'investigatorAffiliation': 'Cairo University'}}}}