Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-28 @ 6:25 PM
Study NCT ID:
NCT00369668
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcaura@hhp.ufl.edu', 'phone': '352-294-1623', 'title': 'James Cauraugh, Ph.D., PI', 'organization': 'University of Florida, Motor Behavior Laboratory'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years, 10 months', 'eventGroups': [{'id': 'EG000', 'title': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Box and Block Test; Data Collected = Number of Blocks Moved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.'}, {'id': 'OG001', 'title': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation'}], 'classes': [{'title': 'Baseline/Pretest', 'categories': [{'measurements': [{'value': '24.5', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '40', 'spread': '27.1', 'groupId': 'OG002'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '27.5', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '42', 'spread': '26.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30', 'ciLowerLimit': '22.5', 'ciUpperLimit': '37.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.65', 'groupDescription': 'Group by Test Session ANOVA with repeated measures on second factor.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Greenhouse-Geisser degrees of freedom adjustment was not necessary.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)', 'description': 'A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.', 'unitOfMeasure': 'Blocks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.'}, {'type': 'PRIMARY', 'title': 'Fugl-Meyer Upper Extremity Motor Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity', 'description': 'Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.'}, {'id': 'OG001', 'title': 'Low Intensity', 'description': 'Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.'}], 'classes': [{'title': 'Baseline/Pretest', 'categories': [{'measurements': [{'value': '39', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '41', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '53', 'spread': '9.7', 'groupId': 'OG002'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '42', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '45', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '56', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)', 'description': 'FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.'}, {'type': 'PRIMARY', 'title': 'Fractionated Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.'}, {'id': 'OG001', 'title': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation'}], 'classes': [{'title': 'Baseline/Pretest', 'categories': [{'measurements': [{'value': '179', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '225', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '135', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '170', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '241', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '161', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)', 'description': 'Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.'}, {'id': 'FG001', 'title': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.'}, {'id': 'FG002', 'title': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Original number of participants to be recruited for each group.', 'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Started August 2006 and ended June 2009', 'preAssignmentDetails': 'Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.'}, {'id': 'BG001', 'title': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.'}, {'id': 'BG002', 'title': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '2.6', 'groupId': 'BG002'}, {'value': '65.2', 'spread': '6.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2006-08-24', 'resultsFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-13', 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Box and Block Test; Data Collected = Number of Blocks Moved', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)', 'description': 'A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.'}, {'measure': 'Fugl-Meyer Upper Extremity Motor Test', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)', 'description': 'FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.'}, {'measure': 'Fractionated Reaction Time', 'timeFrame': 'Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)', 'description': 'Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Physical Therapy Techniques', 'Occupational Therapy', 'Upper Extremity; Motor skills'], 'conditions': ['Cerebrovascular Accident', 'Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '19164850', 'type': 'BACKGROUND', 'citation': 'Cauraugh JH, Coombes SA, Lodha N, Naik SK, Summers JJ. Upper extremity improvements in chronic stroke: coupled bilateral load training. Restor Neurol Neurosci. 2009;27(1):17-25. doi: 10.3233/RNN-2009-0455.'}, {'pmid': '14617717', 'type': 'RESULT', 'citation': 'Cauraugh JH, Kim SB. Stroke motor recovery: active neuromuscular stimulation and repetitive practice schedules. J Neurol Neurosurg Psychiatry. 2003 Nov;74(11):1562-6. doi: 10.1136/jnnp.74.11.1562.'}, {'pmid': '12052996', 'type': 'RESULT', 'citation': 'Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.'}, {'pmid': '14568122', 'type': 'RESULT', 'citation': 'Cauraugh JH, Kim SB. Chronic stroke motor recovery: duration of active neuromuscular stimulation. J Neurol Sci. 2003 Nov 15;215(1-2):13-9. doi: 10.1016/s0022-510x(03)00169-2.'}, {'pmid': '17904594', 'type': 'RESULT', 'citation': 'Richards LG, Stewart KC, Woodbury ML, Senesac C, Cauraugh JH. Movement-dependent stroke recovery: a systematic review and meta-analysis of TMS and fMRI evidence. Neuropsychologia. 2008 Jan 15;46(1):3-11. doi: 10.1016/j.neuropsychologia.2007.08.013. Epub 2007 Aug 24.'}, {'pmid': '20435515', 'type': 'RESULT', 'citation': 'Lodha N, Naik SK, Coombes SA, Cauraugh JH. Force control and degree of motor impairments in chronic stroke. Clin Neurophysiol. 2010 Nov;121(11):1952-61. doi: 10.1016/j.clinph.2010.04.005.'}, {'pmid': '21448576', 'type': 'RESULT', 'citation': 'Naik SK, Patten C, Lodha N, Coombes SA, Cauraugh JH. Force control deficits in chronic stroke: grip formation and release phases. Exp Brain Res. 2011 May;211(1):1-15. doi: 10.1007/s00221-011-2637-8. Epub 2011 Mar 30.'}, {'pmid': '19926154', 'type': 'RESULT', 'citation': 'Cauraugh JH, Lodha N, Naik SK, Summers JJ. Bilateral movement training and stroke motor recovery progress: a structured review and meta-analysis. Hum Mov Sci. 2010 Oct;29(5):853-70. doi: 10.1016/j.humov.2009.09.004. Epub 2009 Nov 18.'}, {'pmid': '34695300', 'type': 'DERIVED', 'citation': 'Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.', 'detailedDescription': "Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position\n* score less than a 56 on the UE subscale of the Fugl-Meyer Assessment\n* an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated\n* unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution\n* free of major post stroke complications\n* able to attend therapy 2 days/week or 4 days/week for 2 weeks\n* score at least a 16 on the Mini Mental Status Examination\n* able to discriminate sharp from dull and light touch using traditional sensation tests.\n\nExclusion Criteria:\n\n* hemiparetic arm is insensate\n* motor impairments from stroke on opposite side of body\n* pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia\n* Legal blindness or severe visual impairment; 5) Life expectancy less than one year\n* Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension \\< 40º; passive wrist extension \\< 40º; passive elbow extension \\<40º; shoulder flexion/abduction \\< 80º)\n* History of sustained alcoholism or drug abuse in the last six months\n* Has pacemaker or other implanted device\n* pregnant"}, 'identificationModule': {'nctId': 'NCT00369668', 'briefTitle': 'Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training', 'orgStudyIdInfo': {'id': '00061194'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.', 'interventionNames': ['Behavioral: Bilateral movements and neuromuscular electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Intensity', 'description': 'Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.', 'interventionNames': ['Behavioral: Bilateral movements and neuromuscular electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation', 'interventionNames': ['Behavioral: Bilateral movements and sham electrical stimulation']}], 'interventions': [{'name': 'Bilateral movements and neuromuscular electrical stimulation', 'type': 'BEHAVIORAL', 'otherNames': ['functional electrical stimulation'], 'description': "Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.", 'armGroupLabels': ['High Intensity']}, {'name': 'Bilateral movements and neuromuscular electrical stimulation', 'type': 'BEHAVIORAL', 'otherNames': ['functional electrical stimulation'], 'description': "Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.", 'armGroupLabels': ['Low Intensity']}, {'name': 'Bilateral movements and sham electrical stimulation', 'type': 'BEHAVIORAL', 'otherNames': ['functional electrical stimulation - sham'], 'description': 'Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Motor Behavior Laboratory, University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'James H. Cauraugh, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}