Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT03767894
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2018-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MyHand: An Active Hand Orthosis for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'js1165@columbia.edu', 'phone': '(212) 305-4818', 'title': 'Dr. Joel Stein', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on Action Research Arm Test (ARAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.46', 'spread': '2.184', 'groupId': 'OG000'}]}]}, {'title': 'Post Unassisted (week 4)', 'categories': [{'measurements': [{'value': '14.82', 'spread': '2.148', 'groupId': 'OG000'}]}]}, {'title': 'Post Assisted (week 4)', 'categories': [{'measurements': [{'value': '13.09', 'spread': '1.43', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.36', 'pValueComment': 'a priori threshold: p\\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.', 'groupDescription': 'Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjustment for p-value is 2.', 'nonInferiorityComment': 'Descriptive analysis (paired sample t-test)'}, {'pValue': '0.207', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.72', 'pValueComment': 'a priori threshold: p\\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.', 'groupDescription': 'Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjustment for p-value is 2.', 'nonInferiorityComment': 'Descriptive analysis (paired sample t-test)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the 11 subjects that completed the study were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.36', 'spread': '1.521', 'groupId': 'OG000'}]}]}, {'title': 'Post Unassisted (week 4)', 'categories': [{'measurements': [{'value': '28', 'spread': '1.854', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.64', 'pValueComment': 'a priori threshold: p\\<0.05', 'groupDescription': 'Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': '2-tailed', 'nonInferiorityComment': 'Descriptive analysis (paired sample t-test)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance.\n\nPlease note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the 11 subjects that completed the study were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Score on Modified Ashworth Scale (MAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'title': 'Elbow Flexors (baseline)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Elbow Extensors (baseline)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Wrist Flexors (baseline)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Wrist Extensors (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Finger Flexors (baseline)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Finger Extensors (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction).\n\nPlease note: MAS is officially scored on a 5-point scale that includes "1+" (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline scores on MAS. Only the 11 subjects that completed the study were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Score on Box and Blocks Test (BBT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47', 'spread': '2.289', 'groupId': 'OG000'}]}]}, {'title': 'Post Unassisted (week 4)', 'categories': [{'measurements': [{'value': '35', 'spread': '1.843', 'groupId': 'OG000'}]}]}, {'title': 'Post Assisted (week 4)', 'categories': [{'measurements': [{'value': '24', 'spread': '0.585', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.09', 'pValueComment': 'a priori threshold: p\\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.', 'groupDescription': 'Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjustment for p-value is 2.', 'nonInferiorityComment': 'Descriptive analysis (paired Wilcoxon)'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1', 'pValueComment': 'a priori threshold: p\\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.', 'groupDescription': 'Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjustment for p-value is 2.', 'nonInferiorityComment': 'Descriptive analysis (paired Wilcoxon)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.', 'unitOfMeasure': 'Blocks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the 11 subjects that completed the study were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Completing Treatment Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 Weeks', 'description': 'The number of participants who completed the full treatment protocol (12 training sessions).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the treatment protocol (12 sessions). Only the 11 subjects that completed the study were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Total Number of Adverse Events During Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 Weeks', 'description': 'All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who experienced adverse events. Only the 11 subjects that completed the study were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MyHand Orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.\n\nEMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.\n\nShoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Stroke', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Ischemic Stroke', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Hemorragic Stroke', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown Type (by participant)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '11 participants participated in and completed the intervention protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-13', 'size': 212540, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-15T17:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2018-11-14', 'resultsFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-18', 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Action Research Arm Test (ARAT)', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.'}, {'measure': 'Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance.\n\nPlease note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.'}], 'secondaryOutcomes': [{'measure': 'Score on Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline', 'description': 'The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction).\n\nPlease note: MAS is officially scored on a 5-point scale that includes "1+" (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale.'}, {'measure': 'Score on Box and Blocks Test (BBT)', 'timeFrame': 'Baseline; Post-test at Week 4', 'description': 'The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.'}, {'measure': 'Number of Participants Completing Treatment Protocol', 'timeFrame': '4 Weeks', 'description': 'The number of participants who completed the full treatment protocol (12 training sessions).'}, {'measure': 'Total Number of Adverse Events During Intervention', 'timeFrame': '4 Weeks', 'description': 'All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hand orthosis', 'Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.', 'detailedDescription': 'Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over 18 years of age\n* History of stroke resulting in significant upper limb impairment\n* Full passive range of motion\n* Gross control of the proximal upper extremity\n* Lacks timely grasp/release\n* No more than moderate flexor tone\n* Intact cognition\n\nExclusion criteria include:\n\n* Other Neurological/orthopedic disorders\n* Excessive spasticity/contracture'}, 'identificationModule': {'nctId': 'NCT03767894', 'briefTitle': 'MyHand: An Active Hand Orthosis for Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'MyHand: An Active Hand Orthosis for Stroke Patients', 'orgStudyIdInfo': {'id': 'AAAP8752'}, 'secondaryIdInfos': [{'id': 'IIS-1526960', 'type': 'OTHER_GRANT', 'domain': 'National Science Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyHand orthosis', 'description': 'Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an electromyography (EMG) band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.', 'interventionNames': ['Device: EMG Band', 'Device: Shoulder harness']}], 'interventions': [{'name': 'EMG Band', 'type': 'DEVICE', 'description': 'The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.', 'armGroupLabels': ['MyHand orthosis']}, {'name': 'Shoulder harness', 'type': 'DEVICE', 'description': 'The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.', 'armGroupLabels': ['MyHand orthosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joel Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wallace H. Coulter Foundation', 'class': 'OTHER'}, {'name': 'U.S. National Science Foundation', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Simon Baruch Professor of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Joel Stein, MD', 'investigatorAffiliation': 'Columbia University'}}}}