Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-28 @ 8:35 PM
Study NCT ID:
NCT04276467
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of the ICF Based Amputee Mobility Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2 Minute Walk Test', 'timeFrame': '3 March 2021'}, {'measure': 'Amputee Mobility Predictor', 'timeFrame': '3 March 2021'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': "Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lower Limb Amputee', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral and traumatic lower limb loss\n* Prosthesis use for at least 6 months\n\nExclusion Criteria:\n\n* Not speaking or understanding Turkish\n* Not having cognitive skills to perform the tests'}, 'identificationModule': {'nctId': 'NCT04276467', 'briefTitle': 'Development of the ICF Based Amputee Mobility Scale', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale', 'orgStudyIdInfo': {'id': 'GO 19/773'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Yasin Ekinci', 'investigatorAffiliation': 'Hacettepe University'}}}}