Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00975156
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Ambulation Post Stroke With Robotic Training
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.noser@memorialhermann.org', 'title': 'Elizabeth Noser', 'organization': 'Mischer Neuroscience Institute, Memorial Hermann-TMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations include: small sample (n=21 enrolled, n=20 completed) and significant (p=0.025) difference between groups in time since stroke (Lokomat group, time since stroke mean=1353.60 days; Conventional group, time since stroke mean=525.00 days).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lokomat Intervention', 'description': 'Robotic-assisted gait therapy', 'otherNumAtRisk': 11, 'otherNumAffected': 5, 'seriousNumAtRisk': 11, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Conventional physical therapy', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Minor skin breakdown', 'notes': 'minor skin breakdown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Skin breakdown', 'notes': 'Skin breakdown as a result of therapy; adverse event deemed "definitely related" to protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypotensive episode', 'notes': 'Sudden drop in blood pressure at subject\'s home leading to brief hospitalization; adverse event deemed "unrelated" to protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Chest pain', 'notes': 'Sudden chest pain prior to therapy leading to ER visit and brief hospitalization; adverse event deemed "unrelated" to protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Stroke', 'notes': 'Subject with a second stroke during the post-treatment phase of study participation; adverse event deemed "unrelated" to protocol.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '10-meter Walking Test (10mWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Intervention 10-meter Walking Test (10mWT) Outcome', 'description': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.'}, {'id': 'OG001', 'title': 'Standard of Care 10mWT Outcome', 'description': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.'}, {'id': 'OG002', 'title': 'All Participants 10mWT Outcome', 'description': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Post-Intervention (mean=5.05 days post-therapy)', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Three-Month Follow-up', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention', 'unitOfMeasure': 'meters per second (m/s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was determined per protocol (i.e.between-group variation)'}, {'type': 'SECONDARY', 'title': '6 Minute Walking Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome', 'description': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.'}, {'id': 'OG001', 'title': 'Standard of Care 6MWD Outcome', 'description': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.'}, {'id': 'OG002', 'title': 'All Participants 6MWD Outcome', 'description': 'Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '53.94', 'spread': '30.53', 'groupId': 'OG000'}, {'value': '48.77', 'spread': '21.04', 'groupId': 'OG001'}, {'value': '51.61', 'spread': '26.16', 'groupId': 'OG002'}]}]}, {'title': 'Post-Intervention (mean=5.05 days post-therapy)', 'categories': [{'measurements': [{'value': '57.02', 'spread': '25.50', 'groupId': 'OG000'}, {'value': '70.26', 'spread': '60.40', 'groupId': 'OG001'}, {'value': '62.98', 'spread': '43.86', 'groupId': 'OG002'}]}]}, {'title': 'Three-Month Follow-up', 'categories': [{'measurements': [{'value': '57.82', 'spread': '25.99', 'groupId': 'OG000'}, {'value': '76.89', 'spread': '62.29', 'groupId': 'OG001'}, {'value': '66.40', 'spread': '45.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention', 'unitOfMeasure': 'meters (m)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lokomat Intervention'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Conventional physical therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lokomat Intervention'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Conventional physical therapy'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.91', 'spread': '8.50', 'groupId': 'BG000'}, {'value': '64.33', 'spread': '10.91', 'groupId': 'BG001'}, {'value': '65.75', 'spread': '9.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2009-09-10', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-14', 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10-meter Walking Test (10mWT)', 'timeFrame': 'Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention'}], 'secondaryOutcomes': [{'measure': '6 Minute Walking Distance (6MWD)', 'timeFrame': 'Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan\n* Age\\>18\n* At least 3 months post stroke at time of enrollment into study\n* Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently\n* Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4\n* Ability to perform Lokomat ambulation training with assistance of 1 therapist\n* Ability to follow a three-step command\n* Physician approval for patient participation\n* Ability to give informed consent\n* Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies\n\nExclusion Criteria:\n\n* Serious cardiac condition\n* Uncontrolled blood pressure, defined as \\> 200 or diastolic \\> 100 at rest\n* Hx of serious chronic obstructive pulmonary disease or oxygen dependence\n* Sever weight bearing pain\n* Lower extremity amputation\n* Claudication while walking\n* Life expectancy \\< 1 year\n* History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months\n* Severe orthopedic problem\n* Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study'}, 'identificationModule': {'nctId': 'NCT00975156', 'briefTitle': 'Improving Ambulation Post Stroke With Robotic Training', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Improving Ambulation Post Stroke With Robotic Training', 'orgStudyIdInfo': {'id': 'HSC-MH-08-0206'}, 'secondaryIdInfos': [{'id': 'Medallion Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lokomat Intervention', 'description': 'Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).', 'interventionNames': ['Device: Lokomat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'Conventional physical therapy', 'armGroupLabels': ['Standard of Care']}, {'name': 'Lokomat', 'type': 'DEVICE', 'description': 'Robotic-assisted walking device', 'armGroupLabels': ['Lokomat Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Elizabeth Noser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor - Neurology', 'investigatorFullName': 'Elizabeth Noser', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}