Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT05165134
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2021-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hallux Valgus Conservative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pretest and posttest Control group randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hallux valgus angle (HVA )', 'timeFrame': '8 weeks', 'description': 'Hallux valgus angle measured by x ray'}, {'measure': 'Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.', 'detailedDescription': '30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups\n\n1. st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.\n2. nd group receive placebo tape bilaterally and had the same measurements.\n\n2 groups were on a group of exercises'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mobile hallux valgus\n\nExclusion Criteria:\n\n* using orthotics\n* knee malalignment'}, 'identificationModule': {'nctId': 'NCT05165134', 'acronym': 'RCT', 'briefTitle': 'Hallux Valgus Conservative Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle', 'orgStudyIdInfo': {'id': 'JU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental kinesiotape group A', 'description': 'Kinesiotape group', 'interventionNames': ['Other: Kinesiotape']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo kinesiotape group B', 'description': 'Control group', 'interventionNames': ['Other: Kinesiotape']}], 'interventions': [{'name': 'Kinesiotape', 'type': 'OTHER', 'description': 'Elastic tape used for mechanical correction of the deformity in study group and placebo in control group', 'armGroupLabels': ['Experimental kinesiotape group A', 'Placebo kinesiotape group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Jizan', 'state': 'Jazan Region', 'country': 'Saudi Arabia', 'facility': 'Jazan University', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}], 'overallOfficials': [{'name': 'Mohamed M Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of physical therapy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'March 2022', 'ipdSharing': 'YES', 'description': 'All will be accessible on request', 'accessCriteria': 'Thru e mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant Professor of physical therapy', 'investigatorFullName': 'Mohammed Moustafa', 'investigatorAffiliation': 'University of Jazan'}}}}