Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 9:25 AM
Study NCT ID:
NCT06958133
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2025-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2025-04-26', 'studyFirstSubmitQcDate': '2025-05-03', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively', 'timeFrame': '28 days', 'description': 'VAS scores ranging from 0 (no pain) to 10 (worst pain) measured at postoperative day 1, day 7, and day 28.'}], 'secondaryOutcomes': [{'measure': 'Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.', 'timeFrame': '28 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle fractures, kinesiology'], 'conditions': ['Ankle Fractures', 'Syndesmotic Injuries', 'Postoperative Rehabilitation']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aimed to evaluate the effects of postoperative Kinesio taping on pain, range of motion, and edema in patients undergoing surgical fixation for Weber type B lateral malleolar fractures.', 'detailedDescription': 'Patients with Weber type B lateral malleolar fractures treated surgically were randomized into two groups: a control group receiving standard rehabilitation and an intervention group receiving additional Kinesio taping. Outcomes assessed included visual analog scale (VAS) pain scores, dorsiflexion range of motion, and circumferential edema measurements at 1, 7, and 28 days postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Patients diagnosed with isolated Weber type B lateral malleolar fractures requiring surgical fixation\n* Surgery performed within 7 days of injury\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Open fractures\n* Associated fractures of the medial or posterior malleolus requiring fixation\n* Polytrauma patients\n* History of previous ankle fractures or surgeries on the affected side\n* Neurological or vascular compromise of the affected limb\n* Known allergy to adhesive materials'}, 'identificationModule': {'nctId': 'NCT06958133', 'acronym': 'KT-WeberB', 'briefTitle': 'Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'The Effects of Postoperative Kinesio Taping on Pain, Range of Motion, and Edema in Weber Type B Lateral Malleolar Fractures: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KT-WeberB-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'Standard postoperative rehabilitation without Kinesio taping.', 'interventionNames': ['Other: Standard Postoperative Rehabilitation']}, {'type': 'OTHER', 'label': 'Kinesio Taping Group', 'description': 'Standard postoperative rehabilitation plus Kinesio taping application.', 'interventionNames': ['Other: Standard Postoperative Rehabilitation', 'Other: Kinesio Taping']}], 'interventions': [{'name': 'Standard Postoperative Rehabilitation', 'type': 'OTHER', 'description': 'Standard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping.', 'armGroupLabels': ['Control Group', 'Kinesio Taping Group']}, {'name': 'Kinesio Taping', 'type': 'OTHER', 'description': 'Kinesio taping applied over the surgical ankle to assist in reducing postoperative pain, swelling, and improving range of motion.', 'armGroupLabels': ['Kinesio Taping Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34752', 'city': 'Istanbul', 'state': 'ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Fatih Sultan Mehmet Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}