Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-29 @ 12:04 AM
Study NCT ID:
NCT01210833
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2010-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using HandTutor With Traumatic Hand Injuries: Characterizing the System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D017695', 'term': 'Soft Tissue Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2010-08-29', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of movement (ROM)', 'timeFrame': 'up to 12 months after the injury', 'description': 'Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor'}], 'secondaryOutcomes': [{'measure': 'performance in HandTutor', 'timeFrame': 'up to 12 months after the injury', 'description': 'The final score the participants get when exercising with the HandTutor.'}, {'measure': 'daily life functioning', 'timeFrame': 'up to 12 months after the injury', 'description': 'Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.'}, {'measure': 'motor performance skills', 'timeFrame': 'up to 12 months after the injury', 'description': 'Measured by Purdue Pegboard Test'}, {'measure': 'enjoyment', 'timeFrame': 'up to 12 months after the injury', 'description': 'Measured by SFQ-Specific feedback questionnaire.'}, {'measure': 'pain', 'timeFrame': 'up to 12 months after the injury', 'description': 'Measured by VAS-Visual analogue scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Finger Fractures', 'Tendon Injuries', 'Soft Tissue Injuries'], 'conditions': ['Hand Injuries']}, 'descriptionModule': {'briefSummary': 'HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.\n\nThe HandTutor has been used and tested with a stroke population, and it seems potential to be used with hand injuried population. As a first step, it is important to investigate the characteristics of the system and how it is matching the hand injuried population.\n\nThe purpose if this study is to characterize the HandTuror system and the focused objectives are:\n\n1. To examine the test-retest reliability of the system when measuring the range of motion (ROM) of the the fingers among healthy people (control group).\n2. To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer).\n3. To examine the ability of the system to distinguish between healthy people and hand injured people.\n4. To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.\n5. To examine the participants feedback for using the HandTutor (degree of enjoyment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hand Injuries causing a disfunction of one finger or more of the fingers 2nd-5th.\n* Six weeks at least after the injury/surgery.\n* Allowed to exercise their fingers with no contraindications according to the orthopedic surgeon instructions.\n* With no open wounds.\n\nExclusion Criteria:\n\n* Peripheral nerves injuries.\n* Digital nerves injuries.\n* Sensation problems.\n* CRPS-complex regional pain syndrome.\n* Cognitive impairments.\n* Head trauma.'}, 'identificationModule': {'nctId': 'NCT01210833', 'briefTitle': 'Using HandTutor With Traumatic Hand Injuries: Characterizing the System', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Using HandTutor With Traumatic Hand Injuries: Characterizing the System', 'orgStudyIdInfo': {'id': 'MMC10k112/2010CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy participants', 'description': 'Healthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling.', 'interventionNames': ['Device: HandTutor System']}, {'type': 'EXPERIMENTAL', 'label': 'Hand Injured participants', 'description': 'Participants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic.', 'interventionNames': ['Device: HandTutor System']}], 'interventions': [{'name': 'HandTutor System', 'type': 'DEVICE', 'description': 'Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.', 'armGroupLabels': ['Hand Injured participants', 'Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naẕerat ‘Illit', 'country': 'Israel', 'facility': 'Clalit Health Service, Southern Clinic, Occupational Therapy Department', 'geoPoint': {'lat': 32.70816, 'lon': 35.32469}}], 'overallOfficials': [{'name': 'Manal A. Najjar, M.Sc. in O.T', 'role': 'STUDY_DIRECTOR', 'affiliation': "Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}