Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-01 @ 7:39 AM
Study NCT ID:
NCT05898568
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Jebsen Taylor Hand Function Test', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'Used to assess upper extremity functions. Activities are evaluated on a time basis.'}, {'measure': 'visual analog scale (VAS)', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'marks the severity of pain between 0 and 10.'}, {'measure': 'duruöz hand index', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'kitchen work, evaluates cleaning, workplace and other activities of daily living. The total score is between 0-90.'}, {'measure': 'Sammes Weinstein Monofilament Test (SWMT)', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'sensory threshold is used for assessment.sensed monofilament values will be collected and recorded. The highest total score will be considered as 15.'}, {'measure': 'Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'activity participation level will be assessed by Q-DASH.Each question will be scored between 1-5 points (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: not at all). The total score will be recorded.'}, {'measure': 'Jamar dynamometer', 'timeFrame': 'from baseline to the end of the treatment (4 week)', 'description': 'Jamar dynamometer will be used for grip strength. 3 repetitive measurements will be made and the average will be recorded.(in kilograms)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Nerve Injury, Virtual Reality, Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.\n* clinical impression was made.\n* out patient with median, ulnar, and radial nerve repair.\n* completed the 6th postoperative week.\n\nExclusion Criteria:\n\n* Those who have communication problems and users\n* With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.\n\nthose with the disease\n\n\\- Patients with multiple traumas'}, 'identificationModule': {'nctId': 'NCT05898568', 'briefTitle': 'Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy', 'orgStudyIdInfo': {'id': 'E-66175679-514.13.02-960185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental: virtual reality', 'description': 'In addition to routine hand care programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days, 20 minutes) virtual reality based movement therapy program will be applied.', 'interventionNames': ['Device: virtual reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control:routine treatment', 'description': '20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented.', 'interventionNames': ['Behavioral: routine treatment']}], 'interventions': [{'name': 'virtual reality', 'type': 'DEVICE', 'description': 'In addition to the routine hand rehabilitation programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days a week, 20 minutes) virtual reality based movement therapy program will be applied.', 'armGroupLabels': ['experimental: virtual reality']}, {'name': 'routine treatment', 'type': 'BEHAVIORAL', 'description': '20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.', 'armGroupLabels': ['control:routine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Kocaeli', 'state': 'Arızlı', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'occupational therapist', 'investigatorFullName': 'Serkan Kablanoğlu', 'investigatorAffiliation': 'Kocaeli University'}}}}