Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-27 @ 11:20 AM
Study NCT ID:
NCT03392493
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-assisted Hand Rehabilitation for Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single Blind (Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'AB or BA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment：Upper Limb section', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Upper Limb motor function'}], 'secondaryOutcomes': [{'measure': 'Box and block test', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Upper Limb motor function'}, {'measure': 'EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Grip strength'}, {'measure': 'Dynanometer', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Grip strength'}, {'measure': 'Semmes-Weinstein hand monofilament', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Light touch'}, {'measure': 'Revision of the Nottingham Sensory Assessment', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Proprioception'}, {'measure': 'Modified barthel index', 'timeFrame': 'Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month', 'description': 'Activity of daily live ability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Robotic rehabilitation', 'Hand function', 'Activities of Daily Living'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '1088404', 'type': 'BACKGROUND', 'citation': 'Hatano S. 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Dose-response relationship of robot-assisted stroke motor rehabilitation: the impact of initial motor status. Stroke. 2012 Oct;43(10):2729-34. doi: 10.1161/STROKEAHA.112.658807. Epub 2012 Aug 14.'}, {'type': 'BACKGROUND', 'citation': 'Lincoln, N., J. Jackson, and S. Adams, Reliability and revision of the Nottingham Sensory Assessment for stroke patients. Physiotherapy, 1998. 84(8): p. 358-365.'}, {'pmid': '19261767', 'type': 'BACKGROUND', 'citation': 'Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.'}, {'pmid': '3805636', 'type': 'BACKGROUND', 'citation': 'Bell-Krotoski J, Tomancik E. The repeatability of testing with Semmes-Weinstein monofilaments. J Hand Surg Am. 1987 Jan;12(1):155-61. doi: 10.1016/s0363-5023(87)80189-2.'}]}, 'descriptionModule': {'briefSummary': 'Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.', 'detailedDescription': 'Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.\n\nMaterials and Methods: Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA) for hand evaluations, Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First stroke with hemiplegia\n* Chronicity \\> 3 months\n* Could understand the instructions\n* Brunnstrom stageⅡ-Ⅴ\n* Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile\\< 2; Kinaesthetic \\< 3)\n* Modified Ashworth Scale \\< 3\n\nExclusion Criteria:\n\n* Age younger than 20 and older than75 years\n* Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly\n* Individuals with other medical symptoms that can affect movement"}, 'identificationModule': {'nctId': 'NCT03392493', 'briefTitle': 'Robot-assisted Hand Rehabilitation for Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke', 'orgStudyIdInfo': {'id': 'TMU-JIRB N201704068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week)', 'interventionNames': ['Behavioral: Robot-assisted hand rehabilitation', 'Behavioral: Standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)', 'interventionNames': ['Behavioral: Robot-assisted hand rehabilitation', 'Behavioral: Standard treatment']}], 'interventions': [{'name': 'Robot-assisted hand rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Robot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Standard treatment', 'type': 'BEHAVIORAL', 'description': 'Standard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Jui chi Lin, master', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University, Taiwan, R.O.C.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}