Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05706818
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2023-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Community Integration Questionnaire-Revised', 'timeFrame': '1st day', 'description': "The Community Integration Questionnaire-Revised (CIQ-R) is a self-report, standardized instrument designed to assess an individual's degree of community integration. On this multisectional scale, patients get a minimum of 0 points (worst condition) and a maximum of 35 points (best condition)."}, {'measure': 'The Community Integration Questionnaire-Revised', 'timeFrame': '5 days later', 'description': "The Community Integration Questionnaire-Revised (CIQ-R) is a self-report, standardized instrument designed to assess an individual's degree of community integration. On this multisectional scale, patients get a minimum of 0 points (worst condition) and a maximum of 35 points (best condition)."}, {'measure': 'Trinity Amputation and Prosthesis Experience Scales', 'timeFrame': '1st day', 'description': 'The Trinity Amputation and Prosthesis Experience Scales (TAPES) is a self-administered questionnaire that comprises psychosocial adjustment, activity restriction, and prosthetic satisfaction domains, each with three subscales.'}, {'measure': 'The Amputee Body Image Scale', 'timeFrame': '1st day', 'description': "The Amputee Body Image Scale affects the individual's perception of their own physical condition, life satisfaction, and well-being. The ABIS consists of 20 items and is scored on a 5-point Likert scale. Three items (3, 12, and 16) are reverse scored. The total score varies between 20-100. A high score indicates poor body image."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lower limb amputees', 'community integration', 'social participation', 'validity', 'reliability'], 'conditions': ['Amputation']}, 'referencesModule': {'references': [{'pmid': '27072343', 'type': 'BACKGROUND', 'citation': 'Callaway L, Winkler D, Tippett A, Herd N, Migliorini C, Willer B. The Community Integration Questionnaire - Revised: Australian normative data and measurement of electronic social networking. Aust Occup Ther J. 2016 Jun;63(3):143-53. doi: 10.1111/1440-1630.12284. Epub 2016 Apr 13.'}, {'pmid': '21697202', 'type': 'BACKGROUND', 'citation': 'Topuz S, Ulger O, Yakut Y, Gul Sener F. Reliability and construct validity of the Turkish version of the Trinity Amputation and Prosthetic Experience Scales (TAPES) in lower limb amputees. Prosthet Orthot Int. 2011 Jun;35(2):201-6. doi: 10.1177/0309364611407678.'}, {'pmid': '20023358', 'type': 'BACKGROUND', 'citation': 'Bumin G, Bayramlar K, Yakut Y, Sener GY. Cross cultural adaptation and reliability of the Turkish version of Amputee Body Image Scale (ABIS). J Back Musculoskelet Rehabil. 2009;22(1):11-6. doi: 10.3233/BMR-2009-0208.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. The main questions it aims to answer are:\n\n* The Turkish version of the Community Integration Questionnaire-Revised is valid for lower extremity amputees.\n* The Turkish version of the Community Integration Questionnaire-Revised is reliable for lower extremity amputees.\n\nParticipants will:\n\n• Fill out general information, CIQ-R, TAPES, and ABIS forms.', 'detailedDescription': 'The aim of this study is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. Lower limb amputees aged 18-65 years who used prostheses for at least 6 months and volunteered to participate in the study were included in the study. The adaptation of amputees to prostheses was evaluated with the "Trinity Amputation and Prosthesis Experience Scale" (TAPES), their perception of physical appearance with the "Amputee Body Image Scale" (ABIS), and their community integration with the CIQ-R. Correlation with TAPES and ABIS and confirmatory factor analysis were performed to determine the construct validity of the CIQ-R scale. The test-retest reliability of the CIQ-R scale was determined by the intraclass correlation coefficient (ICC) method. Internal consistency analysis was evaluated with Cronbach\'s alpha. 90 amputees were included in the study (mean age: 40.96±12.89 years; BMI: 25.55±5.5 kg/m2). The CIQ-R scale was reapplied to 18 of the participants 1 week later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lower extremity amputees between the ages of 18 and 65 with a prosthesis usage period of more than 1 year who can speak and read Turkish.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those between the ages of 18 and 65\n* Lower extremity amputation\n* Use of a prosthesis for at least one year\n* Individuals who volunteered to participate in the research.\n\nExclusion Criteria:\n\n* Have any known cognitive problems\n* Illiterate individuals were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05706818', 'briefTitle': 'Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Validity and Reliability of the Turkish Version of the Community Integration Questionnaire-Revised (CIQ-R) in Lower Limb Amputees', 'orgStudyIdInfo': {'id': 'GO 19/1039'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Validity and reliability study', 'type': 'OTHER', 'description': 'Validity and reliability assessment of the Community Integration Questionnaire-revised'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Serdar Y ESEN, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pirincipal investigator', 'investigatorFullName': 'Serdar Y ESEN', 'investigatorAffiliation': 'Hacettepe University'}}}}