Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 7:25 PM
Study NCT ID:
NCT06189235
Status:
UNKNOWN
Last Update Posted:
2024-01-03
First Post:
2023-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonography-guided Real-time Modular Systems for Hand Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 149}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline', 'timeFrame': 'Baseline, 2-3 days after baseline, 4-5 days after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 days after baseline', 'timeFrame': 'Baseline, 2-3 days after baseline, 4-5 days after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 4-5 days after baseline', 'timeFrame': 'Baseline, 2-3 days after baseline, 4-5 days after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Ultrasonography platform - Healthy Group - Baseline', 'timeFrame': 'Baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images and films from dominant hand of healthy adults for building the dataset.'}, {'measure': 'Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.'}, {'measure': 'Change in joint ROM - Goniometer - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.'}, {'measure': 'Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.'}, {'measure': 'Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.'}, {'measure': 'Change in single digit force - Force sensors - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'A force sensor will be used to collect the single digit force data in affected and unaffected finger.'}, {'measure': 'Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'A force sensor will be used to collect the single digit force data in affected and unaffected finger.'}, {'measure': 'Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'A force sensor will be used to collect the single digit force data in affected and unaffected finger.'}, {'measure': 'Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'Hand dynamometer will be used to measure the grip strength and pinch strength.'}, {'measure': 'Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'Hand dynamometer will be used to measure the grip strength and pinch strength.'}, {'measure': 'Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'Hand dynamometer will be used to measure the grip strength and pinch strength.'}, {'measure': 'Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.'}, {'measure': 'Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.'}, {'measure': 'Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.'}, {'measure': 'Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - Baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.'}, {'measure': 'Change from Baseline perspective hand function at 2 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 2 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.'}, {'measure': 'Change from Baseline perspective hand function at 4 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 4 weeks after baseline', 'timeFrame': 'Baseline, 2 weeks after baseline, 4 weeks after baseline', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography-guided', 'Biofeedback', 'Hand therapy'], 'conditions': ['Health Adults', 'Patients With Traumatic Hand Injury']}, 'descriptionModule': {'briefSummary': 'This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using.\n\nThis study was divided into two parts. The first part is an observational study design. The ultrasonography-guided real-time modular system will be developed and integrated, and its overall reliability and validity will be tested in this part. Once the software and hardware of the modular system has been established, numerous hand-related ultrasonography data will be collected for building an artificial intelligence model for detecting the anatomic structures in hand, evaluating the status of the tissues in hand.\n\nThe second part is an interventional study design. The clinical application of the modular system on hand injured patients is conducted, and the biofeedback mechanics will also be defined in the second part. The patients will be recruited into the research to receive both traditional rehabilitation and the one which combines with biofeedback training via the modular system. The effect of the traditional and biofeedback-added rehabilitation will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '【Patients】\n\nInclusion Criteria:\n\n* Traumatic hand injury (distal from wrist joint above 8 weeks and within one year)\n* Able to do active motion and resistive activities\n* Understand and cooperate the experiment\n\nExclusion Criteria:\n\n* Burn, amputees or has history of arthritis\n* Combined with other central or peripheral nerve deficits which cause difficulty in movements\n\n【Healthy subjects】\n\nInclusion Criteria:\n\n* No history of traumatic hand injury and other hand related conditions\n* Understand and cooperate the experiment\n\nExclusion Criteria:\n\n* Burn, amputees or has history of arthritis\n* Combined with other central or peripheral nerve deficits which cause difficulty in movements'}, 'identificationModule': {'nctId': 'NCT06189235', 'briefTitle': 'Ultrasonography-guided Real-time Modular Systems for Hand Therapy', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy', 'orgStudyIdInfo': {'id': 'B-ER-111-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'System development: Validation for patients', 'description': 'No intervention. The patients will receive one time of MRI and three times of ultrasound evaluation on the injured area, each evaluaitons will be done by two to three days interval.'}, {'type': 'NO_INTERVENTION', 'label': 'System development: Building dataset from healthy subjects', 'description': 'No intervention. The healthy subjects will receive one time of ultrasound evaluation on the dominant hand, the different part and different axis in dominant hand will be assessed in types of images or films for building the dataset.'}, {'type': 'NO_INTERVENTION', 'label': 'System application: Understanding the recovery patterns in patients', 'description': 'No intervention. The patients will receive three times of ultrasound evaluation on the injured area and hand function assessments, each evaluaitons will be done by two weeks interval.'}, {'type': 'EXPERIMENTAL', 'label': 'System application: Biofeedback training', 'description': 'The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval.\n\nFor this biofeedback training group, the therapist and patients will be asked to use the hint recommanded by modular system to assist the rehabilitation excepting the traditional routine at least two times a week.', 'interventionNames': ['Other: Biofeedback training']}, {'type': 'NO_INTERVENTION', 'label': 'System application: Traditional training', 'description': 'The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval.'}], 'interventions': [{'name': 'Biofeedback training', 'type': 'OTHER', 'description': 'The target of additional biofeedback training is to provide hints which are related to the essential aspects during hand therapy such as the stress on the tissue and the distance of tendon gliding.', 'armGroupLabels': ['System application: Biofeedback training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Chieh Kuo', 'role': 'CONTACT', 'email': 'jkkuo@mail.ncku.edu.tw', 'phone': '886-62353535', 'phoneExt': '5908'}], 'facility': 'National Cheng-Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Li-Chieh Kuo, Ph. D.', 'role': 'CONTACT', 'email': 'jkkuo@mail.ncku.edu.tw', 'phone': '886-62353535', 'phoneExt': '5908'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}