Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT00847704
Status:
TERMINATED
Last Update Posted:
2017-01-23
First Post:
2009-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinic-Based AMES Treatment of Stroke
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': 'cordop@ohsu.edu', 'phone': '503-418-2520', 'title': 'Paul J. Cordo', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to lack of funding lead to only 2 subjects treated and analyzed.'}}, 'adverseEventsModule': {'timeFrame': '1 year, 1 month', 'description': 'Verbal inquiry at the beginning of each training session.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Treatment Group', 'description': 'Device: Subjects receiving AMES treatments.', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fall', 'notes': 'Loss of balance during moving', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fugl-Meyer Assessment of the Lower Extremity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '19.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '21', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timed 10-Meter Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.465', 'spread': '0.055', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '13.66', 'spread': '0.34', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '13.27', 'spread': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Gait Assessment - Time', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stroke Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '234.5', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '258', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '251.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:\n\nTransformed Scale=\\[(Actual raw score-lowest possible raw score)/Possible raw score range\\]x100.\n\nThus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spasticity (Modified Ashworth) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Strength Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'title': 'Dorsiflexion', 'categories': [{'measurements': [{'value': '33.7', 'spread': '41.4', 'groupId': 'OG000'}]}]}, {'title': 'Plantarflexion', 'categories': [{'measurements': [{'value': '31.5', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)', 'description': 'Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).', 'unitOfMeasure': 'Newton meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Active Motion Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Group receiving AMES therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)', 'description': 'Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Group', 'description': 'Device: Assisted movement and enhanced sensation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Group', 'description': 'Device: Assisted movement and enhanced sensation\n\nAssisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.\n\nAssisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time since stroke', 'classes': [{'categories': [{'measurements': [{'value': '113.5', 'spread': '85.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Stroke \\>1 yr prior to enrollment Able to stand independently \\<50% normal strength in affected leg Functioning proprioception in affected leg'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Funding not available.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2009-02-18', 'resultsFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-23', 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment of the Lower Extremity', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.'}], 'secondaryOutcomes': [{'measure': 'Timed 10-Meter Walk', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Gait Assessment - Time'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:\n\nTransformed Scale=\\[(Actual raw score-lowest possible raw score)/Possible raw score range\\]x100.\n\nThus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.'}, {'measure': 'Spasticity (Modified Ashworth) Scale', 'timeFrame': 'Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up', 'description': 'Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.'}, {'measure': 'Strength Test', 'timeFrame': 'First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)', 'description': 'Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).'}, {'measure': 'Active Motion Test', 'timeFrame': 'First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)', 'description': 'Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Rehabilitation', 'Robotics'], 'conditions': ['Stroke', 'Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '18645190', 'type': 'BACKGROUND', 'citation': 'Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.', 'detailedDescription': 'The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 12 months post-stroke\n* Cognitively and behaviorally capable of complying with the regimen\n* Functioning proprioception\n* Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices\n\nExclusion Criteria:\n\n* Fractures of treated limb resulting in loss of range of motion\n* Spinal cord injury\n* Deep vein thrombosis\n* Peripheral nerve injury or neuropathy in the limb affected with motor disability\n* Osteoarthritis limiting range of motion\n* Skin condition not tolerant of device\n* Progressive neurodegenerative disorder\n* Uncontrolled seizure disorder\n* Botox treatment within the last 5 months\n* Baclofen pump'}, 'identificationModule': {'nctId': 'NCT00847704', 'briefTitle': 'Clinic-Based AMES Treatment of Stroke', 'nctIdAliases': ['NCT00600184'], 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects', 'orgStudyIdInfo': {'id': 'IRB 4005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test treatment group', 'description': 'Device: Assisted movement and enhanced sensation', 'interventionNames': ['Device: Assisted movement and enhanced sensation']}], 'interventions': [{'name': 'Assisted movement and enhanced sensation', 'type': 'DEVICE', 'description': 'Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.', 'armGroupLabels': ['Test treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Paul J. Cordo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMES Technology Inc./Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AMES Technology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paul J. Cordo', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}