Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 11:03 AM
Study NCT ID:
NCT04898959
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rasch analysis', 'timeFrame': 'Change from baseline answers of questions following 3 weeks', 'description': 'to perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arabic Activity-specific Balance Confidence', 'Arabic Prosthetic Mobility Questionnaire', 'Psychometric'], 'conditions': ['Filling Out Questionnaires']}, 'referencesModule': {'references': [{'pmid': '25783231', 'type': 'BACKGROUND', 'citation': 'Franchignoni F, Monticone M, Giordano A, Rocca B. Rasch validation of the Prosthetic Mobility Questionnaire: A new outcome measure for assessing mobility in people with lower limb amputation. J Rehabil Med. 2015 May;47(5):460-5. doi: 10.2340/16501977-1954.'}, {'pmid': '26890426', 'type': 'RESULT', 'citation': 'Alghwiri AA, Alghadir AH, Al-Momani MO, Whitney SL. The activities-specific balance confidence scale and berg balance scale: Reliability and validity in Arabic-speaking vestibular patients. J Vestib Res. 2016;25(5-6):253-9. doi: 10.3233/VES-160568.'}, {'pmid': '32039869', 'type': 'RESULT', 'citation': 'Alghwiri AA, Khalil H, Al-Sharman A, El-Salem K. Psychometric properties of the Arabic Activities-specific Balance Confidence scale in people with multiple sclerosis: Reliability, validity, and minimal detectable change. NeuroRehabilitation. 2020;46(1):119-125. doi: 10.3233/NRE-192900.'}, {'pmid': '31354251', 'type': 'RESULT', 'citation': 'Elboim-Gabyzon M, Agmon M, Azaiza F. Psychometric properties of the Arabic version of the Activities-Specific Balance Confidence (ABC) scale in ambulatory, community-dwelling, elderly people. Clin Interv Aging. 2019 Jun 18;14:1075-1084. doi: 10.2147/CIA.S194777. eCollection 2019.'}, {'pmid': '31210649', 'type': 'RESULT', 'citation': 'Burger H, Giordano A, Bavec A, Franchignoni F. The Prosthetic Mobility Questionnaire, a tool for assessing mobility in people with lower-limb amputation: validation of PMQ 2.0 in Slovenia. Int J Rehabil Res. 2019 Sep;42(3):263-269. doi: 10.1097/MRR.0000000000000354.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to perform perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis (RA) to enable its use among Arabic speaking population and to enhance confidence in its use patients with lower limb amputation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unilateral lower limb amputees (above ankle dezarticulation level)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current users of lower limb prosthesis of minum 6 month,\n* to be able to fully understand and appropriately complete the questionnaire,\n* to be unilater amputee.\n\nExclusion Criteria:\n\n* inability to understand and complete the questionnair (e.g. cognitive or language impairment; not native-Arabic speaker),\n* less the 6 month of using the prosthesis,\n* bilateral and partial lower limb amputees'}, 'identificationModule': {'nctId': 'NCT04898959', 'briefTitle': 'Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ) in Saudi Lower Amputees', 'orgStudyIdInfo': {'id': '09.2021.575'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Lower extremity amputees', 'interventionNames': ['Other: Filling out Questionaire']}], 'interventions': [{'name': 'Filling out Questionaire', 'type': 'OTHER', 'description': 'Filling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}