Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06562218
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2024-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Cross-training on an Immobilised Forearm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not know which group they have been assigned to, and the researchers evaluating the results will not know which group participants have been assigned to.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled double-blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wrist isometric flexion muscle strength', 'timeFrame': '1 year', 'description': 'The isometric flexion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.'}, {'measure': 'Wrist isometric extansion muscle strength', 'timeFrame': '1 year', 'description': 'The isometric extansion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fracture', 'immobilisation', 'cross-education', 'muscle strength'], 'conditions': ['Forearm Fracture']}, 'descriptionModule': {'briefSummary': 'The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)\n\nExclusion Criteria:\n\n* Previous upper limb surgery/joint disease - deformity affecting hand-wrist function\n* Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)"}, 'identificationModule': {'nctId': 'NCT06562218', 'briefTitle': 'The Effectiveness of Cross-training on an Immobilised Forearm', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'The Effectiveness of Cross-training on an Immobilised Forearm Due to Fracture', 'orgStudyIdInfo': {'id': 'CTO-CE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cross training group', 'description': 'Group whose healthy arm (unbroken side) is strengthened', 'interventionNames': ['Procedure: isokinetic strengthening exercise']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'group given conventional exercise to the fractured arm', 'interventionNames': ['Procedure: conventional exercise programm']}], 'interventions': [{'name': 'isokinetic strengthening exercise', 'type': 'PROCEDURE', 'description': "Participants' isokinetic strength measurements will be assessed using the Cybex II Humac Norm isokinetic dynamometer. A strengthening programme will be performed for a total of 12 sessions, 3 days a week for 4 weeks, at 20 degrees of flexion, 20 degrees of extension, 60-90 and 180 degrees/s speed.\n\nAt the beginning and end of the 12th session, isokinetic and isometric muscle performance tests will be performed on the healthy wrist, and isometric wrist flexor and extensor strength measurements will be performed in neutral position 1 week after removal of the cast on the fractured wrist.", 'armGroupLabels': ['cross training group']}, {'name': 'conventional exercise programm', 'type': 'PROCEDURE', 'description': 'The immobilised limb was given finger grip exercises.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Taşçıoğlu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dilara Ekici Zincirci', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Dilara Ekici Zincirci', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}