Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 1:01 AM
Study NCT ID:
NCT06356766
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': 'First week, 5th week, 6th week, 12th week', 'description': 'Modified Strickland Formula'}], 'secondaryOutcomes': [{'measure': 'DASH', 'timeFrame': 'First week, 5th week, 6th week, 12th week', 'description': 'Disabilities of the Arm, Shoulder and Hand; min: 0 max: 100, lower scores indicate a lower level of disability'}, {'measure': 'Pain of the affected hand', 'timeFrame': 'First week, 5th week, 6th week, 12th week', 'description': 'Visual Analogue Scale, min:0 cm/mm, max: 10 cm/100 mm, higher scores mean a higher degree of pain'}, {'measure': 'Muscle Strength', 'timeFrame': '12th week', 'description': 'Jamar Hydraulic Hand Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Zone 2 Flexor Tendon Injuries of the Hand']}, 'descriptionModule': {'briefSummary': "The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.\n\nThe aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.\n\nThe face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.\n\nPatients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.\n\nSPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \\<0.05 considered significant in all assessments, and accepted as two-tailed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with isolated Zone 2 flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) injuries,\n* Repair performed within the first 72 hours post-injury,\n* Individuals aged between 18 and 55 years,\n* Patients willing to participate in the study,\n* Ability to attend sessions regularly.\n\nExclusion Criteria:\n\n* Fingers with concomitant fractures, digital nerve injuries, vascular injuries, or significant skin loss accompanying flexor tendon injuries,\n* Bilateral flexor tendon injuries,\n* Patients with replantation or revascularization,\n* Flexor Pollicis Longus tendon injuries of the thumb due to differences in protocols applied and measurement of final outcomes,\n* Patients unable to understand and perform postoperative exercises'}, 'identificationModule': {'nctId': 'NCT06356766', 'briefTitle': 'Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand', 'orgStudyIdInfo': {'id': '30.01.2024/009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation Group', 'description': 'Modified Duran Protocol via telerehabilitation', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face-to-face Rehabilitation Group', 'description': 'Modified Duran Protocol', 'interventionNames': ['Other: Face-to-face rehabilitation']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'Modified Duran Protocol via Telerehabilitation', 'armGroupLabels': ['Telerehabilitation Group']}, {'name': 'Face-to-face rehabilitation', 'type': 'OTHER', 'description': 'Modified Duran Protocol', 'armGroupLabels': ['Face-to-face Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sema Guven', 'role': 'CONTACT', 'email': 'fzt.semaguven@gmail.com', 'phone': '+905077531403'}, {'name': 'Merih Akpınar', 'role': 'CONTACT', 'email': 'merihcaliskan@gmail.com', 'phone': '+905333558843'}], 'facility': 'Istanbul Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sema Güven', 'role': 'CONTACT', 'email': 'fzt.semaguven@gmail.com', 'phone': '+905077531403'}, {'name': 'Fatma M Akpınar', 'role': 'CONTACT', 'email': 'merihcaliskan@gmail.com', 'phone': '+905333558843'}], 'overallOfficials': [{'name': 'Seda Saka', 'role': 'STUDY_CHAIR', 'affiliation': 'Halic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Fatma Merih Akpınar', 'investigatorAffiliation': 'Istanbul University'}}}}