Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02249832
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The General Use of Robots in Stroke Recovery: the Anklebot
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': 'bvolpe1@northwell.edu', 'phone': '(516) 562-3384', 'title': 'Bruce T. Volpe, MD', 'organization': 'Feinstein Institutes for Medical Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).', 'description': 'Safety population included all participants who enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Seated Robotic Ankle Therapy', 'description': 'All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 2, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'neuropathic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'worsening baseline ankle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Gait Speed Group', 'description': 'The low gait speed group included all subjects with a mean gait speed of \\<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}, {'id': 'OG001', 'title': 'Moderate Gait Speed Group', 'description': 'The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}, {'id': 'OG002', 'title': 'High Gait Speed Group', 'description': 'The high gait speed group included all subjects with a mean gait speed of \\>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}], 'classes': [{'title': 'Mean gait speed at baseline', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Mean gait speed at discharge (week 6)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Mean gait speed at 3month FU (overall week 18)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A significance level of 0.05 was used (two-sided).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Gait Speed Group', 'description': 'The low gait speed group included all subjects with a mean gait speed of \\<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.'}, {'id': 'OG001', 'title': 'Moderate Gait Speed Group', 'description': 'The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.'}, {'id': 'OG002', 'title': 'High Gait Speed Group', 'description': 'The high gait speed group included all subjects with a mean gait speed of \\>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.'}], 'classes': [{'title': 'mean gait speed at baseline', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'mean gait speed at discharge (week 6)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'mean gait speed at 3 month FU (overall week 18)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '1.79', 'spread': '0.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A significance level of 0.05 was used (two-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Gait Speed Group', 'description': 'The low gait speed group included all subjects with a mean gait speed of \\<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}, {'id': 'OG001', 'title': 'Moderate Gait Speed Group', 'description': 'The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}, {'id': 'OG002', 'title': 'High Gait Speed Group', 'description': 'The high gait speed group included all subjects with a mean gait speed of \\>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.'}], 'classes': [{'title': 'mean distance at baseline', 'categories': [{'measurements': [{'value': '68.46', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '152.92', 'spread': '9.53', 'groupId': 'OG001'}, {'value': '280.43', 'spread': '19.19', 'groupId': 'OG002'}]}]}, {'title': 'mean distance at discharge (week 6)', 'categories': [{'measurements': [{'value': '79.33', 'spread': '5.38', 'groupId': 'OG000'}, {'value': '180.11', 'spread': '11.64', 'groupId': 'OG001'}, {'value': '319.79', 'spread': '22.91', 'groupId': 'OG002'}]}]}, {'title': 'mean distance at 3 month FU (overall week18)', 'categories': [{'measurements': [{'value': '75.07', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '183.34', 'spread': '14.33', 'groupId': 'OG001'}, {'value': '314.43', 'spread': '21.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A significance level of 0.05 was used (two-sided).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance levels.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Seated Robotic Ankle Therapy', 'description': 'Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': 'All participants received eighteen sessions of seated anklebot training. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Seated Robotic Ankle Therapy', 'description': 'Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-31', 'size': 369234, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-19T15:32', 'hasProtocol': True}, {'date': '2016-05-31', 'size': 190270, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-17T13:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by average admission gait speed on the 10 Meter Walk Test at comfortable pace, according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) gait functioning.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2014-09-23', 'resultsFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-13', 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).'}, {'measure': 'Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.', 'timeFrame': 'baseline, discharge (week 6), 3 month FU (overall week 18)', 'description': 'Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'CVA', 'cerebrovascular accident', 'cerebral stroke', 'robotic therapy', 'anklebot', 'physical therapy'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '20492698', 'type': 'BACKGROUND', 'citation': 'Khanna I, Roy A, Rodgers MM, Krebs HI, Macko RM, Forrester LW. Effects of unilateral robotic limb loading on gait characteristics in subjects with chronic stroke. J Neuroeng Rehabil. 2010 May 21;7:23. doi: 10.1186/1743-0003-7-23.'}, {'pmid': '21346215', 'type': 'BACKGROUND', 'citation': 'Roy A, Krebs HI, Bever CT, Forrester LW, Macko RF, Hogan N. Measurement of passive ankle stiffness in subjects with chronic hemiparesis using a novel ankle robot. J Neurophysiol. 2011 May;105(5):2132-49. doi: 10.1152/jn.01014.2010. Epub 2011 Feb 23.'}, {'pmid': '21115945', 'type': 'BACKGROUND', 'citation': 'Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.'}, {'pmid': '24515923', 'type': 'BACKGROUND', 'citation': 'Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior\n* Cognitive function sufficient enough to understand experiments and follow instructions\n* Some amount of independent ambulation (with orthoses or walker)\n\nExclusion Criteria:\n\n* Botox treatment within 6-weeks of enrollment;\n* Fixed contraction deformity in the affected limb;\n* Complete and total flaccid paralysis of all lower extremity motor function;\n* Unable to ambulate except with the aid of another person'}, 'identificationModule': {'nctId': 'NCT02249832', 'briefTitle': 'The General Use of Robots in Stroke Recovery: the Anklebot', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'The General Use of Robots in Stroke Recovery: the Anklebot', 'orgStudyIdInfo': {'id': '13-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'seated robot-assisted ankle therapy', 'description': 'All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\\>0.8m/sec) functioning.', 'interventionNames': ['Device: seated robot-assisted ankle therapy']}], 'interventions': [{'name': 'seated robot-assisted ankle therapy', 'type': 'DEVICE', 'otherNames': ['Massachusetts Insititute of Technology (MIT) Anklebot'], 'description': 'The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.', 'armGroupLabels': ['seated robot-assisted ankle therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institutes for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Transitions of Long Island Outpatient Rehabilitation', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bruce Volpe', 'investigatorAffiliation': 'Northwell Health'}}}}