Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:57 PM
Study NCT ID:
NCT07489235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Model Description'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-08-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Active Motion (TAM)', 'timeFrame': '12 week', 'description': 'Total active motion will be calculated by summing the active flexion angles of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints and subtracting any extension deficits. Measurements will be performed using a finger goniometer and evaluated according to the Buck-Gramcko classification.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '6, 8, and 12 weeks', 'description': 'Pain intensity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Hand Function', 'timeFrame': '6, 8 and 12 weeks', 'description': 'Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks.'}, {'measure': 'Upper Extremity Function', 'timeFrame': '6, 8, and 12 weeks', 'description': 'Upper extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Lower scores indicate better function.'}, {'measure': 'Grip Strength', 'timeFrame': '6, 8, and 12 weeks', 'description': 'Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms.'}, {'measure': 'Pinch Strength', 'timeFrame': '6, 8, and 12 weeks', 'description': 'Pinch strength will be measured using a pinch meter and recorded in kilograms.'}, {'measure': 'Orthosis Satisfaction', 'timeFrame': '6 weeks', 'description': "Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS)."}, {'measure': 'Complications', 'timeFrame': 'up to 12 weeks', 'description': 'Postoperative complications including tendon rupture, adhesions, edema, and skin irritation will be recorded during the follow-up period.'}, {'measure': 'Return to Daily Activities', 'timeFrame': 'Up to 12 weeks', 'description': 'Time to return to daily activities and work will be recorded in weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['flexor tendon', 'orthosis', 'splint', '3D printing', 'therapy', 'rehabilitation', 'immobilization'], 'conditions': ['Flexor Tendon Injury', 'Tendon Injury - Hand']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study aims to compare the effects of three different wrist positions (30° extension, neutral, and 30° flexion) used in dorsal blocking orthoses during early active mobilization after zone I-II flexor tendon repair. A total of 54 patients will be randomly assigned into three groups. All participants will receive the same rehabilitation protocol. Clinical and functional outcomes including total active motion, pain, complications, functional status, and orthosis satisfaction will be evaluated at 6, 8, and 12 weeks by a blinded assessor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals aged 16 years and older Patients who underwent zone I or II flexor tendon repair using at least a four-strand suture technique Referral to physiotherapy within the first 10 days after surgery Eligibility for a controlled early active mobilization protocol Ability to understand and complete Turkish assessment questionnaires Adequate cognitive function (Montreal Cognitive Assessment score \\>21) Voluntary participation with written informed consent\n\nExclusion Criteria:\n\nThumb tendon repairs Multiple or complex injuries (e.g., concomitant peripheral nerve injury, fractures requiring immobilization, joint dislocation, extensor tendon injury) Active infection Severe edema preventing orthosis use Dermatological conditions or allergies preventing orthosis application Systemic diseases that may affect rehabilitation (e.g., diabetes mellitus, peripheral neuropathy, stroke, advanced rheumatoid arthritis) Pre-existing wrist pain or deformity prior to injury Inability to attend follow-up assessments Non-compliance with the home exercise program'}, 'identificationModule': {'nctId': 'NCT07489235', 'briefTitle': 'Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effects of Different Wrist Positions in 3D-Printed Dorsal Blocking Orthoses on Clinical and Functional Outcomes After Zone I-II Flexor Tendon Repair: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2025 - 2170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wrist Extension Group', 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.', 'interventionNames': ['Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)']}, {'type': 'EXPERIMENTAL', 'label': 'Neutral Wrist Group', 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.', 'interventionNames': ['Device: 3D-Printed Dorsal Blocking Orthosis (wrist neutral)']}, {'type': 'EXPERIMENTAL', 'label': 'Wrist Flexion Group', 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.', 'interventionNames': ['Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)']}], 'interventions': [{'name': '3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)', 'type': 'DEVICE', 'otherNames': ['Early Active Mobilization Protocol'], 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.', 'armGroupLabels': ['Wrist Extension Group']}, {'name': '3D-Printed Dorsal Blocking Orthosis (wrist neutral)', 'type': 'DEVICE', 'otherNames': ['Early Active Mobilization Protocol'], 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.', 'armGroupLabels': ['Neutral Wrist Group']}, {'name': '3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)', 'type': 'DEVICE', 'otherNames': ['Early Active Mobilization Protocol'], 'description': 'Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.', 'armGroupLabels': ['Wrist Flexion Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sedanur Güngör', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University Scientific Research Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc.', 'investigatorFullName': 'Sedanur Güngör', 'investigatorAffiliation': 'Gazi University'}}}}