Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-02 @ 1:00 AM
Study NCT ID:
NCT01087957
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
WalkAide Compared to Ankle-Foot Orthosis (AFO) in 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': 'hrogers@ininc.us', 'phone': '512-721-1922', 'title': 'Helen Rogers PT, PhD', 'organization': 'Innovative Neurotronics'}, 'certainAgreement': {'otherDetails': '(b) Publication- Investigator and Institution agree not to publish the results of the Trial until after the conclusion of the Trial. Investigator agrees to submit to Sponsor copies of any proposed publication at least sixty (60) calendar days in advance of dissemination. Sponsor agrees to review and comment in a timely manner after receipt . All proprietary and/or confidential information of Sponsor must be removed from the Proposed Publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'otherNumAtRisk': 253, 'otherNumAffected': 146, 'seriousNumAtRisk': 253, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'otherNumAtRisk': 242, 'otherNumAffected': 162, 'seriousNumAtRisk': 242, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 173, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 173, 'numAffected': 99}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in back or Lower Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 55, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 36, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other medical conditions', 'notes': 'Various events involving multiple systems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 166, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 149, 'numAffected': 70}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TIA or CVA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure/infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitilization GI disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitilized for abnormal Blood Sugar level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gait Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '.682', 'spread': '.020', 'groupId': 'OG000'}, {'value': '.635', 'spread': '.022', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Improved ambulation status, specific to increase in gait velocity (m/s)', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'PRIMARY', 'title': 'Stroke Impact Scale (SIS) Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '172.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '175.0', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'PRIMARY', 'title': 'Device Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).', 'unitOfMeasure': 'number of device related SAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '218.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '209.2', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '479.4', 'spread': '38.3', 'groupId': 'OG000'}, {'value': '498.0', 'spread': '32.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up \\& Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Floor Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Carpet Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '57.1', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Timed up and Go', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '131.0', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '126.9', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Obstacle Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '169.8', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '182.2', 'spread': '14.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Emory Functional Ambulation Profile Stair Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Berg Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'OG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'FG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nAnkle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'BG001', 'title': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)\n\nWalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.30', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '63.87', 'spread': '11.33', 'groupId': 'BG001'}, {'value': '64.09', 'spread': '11.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time Post Onset of Stroke', 'classes': [{'categories': [{'measurements': [{'value': '6.86', 'spread': '6.64', 'groupId': 'BG000'}, {'value': '6.90', 'spread': '6.43', 'groupId': 'BG001'}, {'value': '6.88', 'spread': '6.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Initial Gait Speed', 'classes': [{'categories': [{'measurements': [{'value': '.487', 'spread': '.21', 'groupId': 'BG000'}, {'value': '.449', 'spread': '.22', 'groupId': 'BG001'}, {'value': '.47', 'spread': '.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters/second', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mini Mental Status Exam', 'classes': [{'categories': [{'measurements': [{'value': '27.49', 'spread': '2.83', 'groupId': 'BG000'}, {'value': '27.62', 'spread': '2.44', 'groupId': 'BG001'}, {'value': '27.54', 'spread': '2.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Mini Mental Status is a measure of cognitive function with a total possible score of 30 points. Any score greater than or equal to 27 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory', 'classes': [{'categories': [{'measurements': [{'value': '8.08', 'spread': '6.58', 'groupId': 'BG000'}, {'value': '7.98', 'spread': '6.32', 'groupId': 'BG001'}, {'value': '8.05', 'spread': '6.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Beck Depression inventory is a 21-question multiple-choice self-report inventory used for measuring the severity of depression. Each of the 21 questions is scored on a scale value of 0 to 3. Total score thresholds recommendations are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.21', 'spread': '5.08', 'groupId': 'BG000'}, {'value': '27.98', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '28.61', 'spread': '5.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms/meters squared', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 495}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2010-03-15', 'resultsFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-14', 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Velocity', 'timeFrame': '6 months', 'description': 'Improved ambulation status, specific to increase in gait velocity (m/s)'}, {'measure': 'Stroke Impact Scale (SIS) Composite Score', 'timeFrame': '6 months', 'description': 'The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.'}, {'measure': 'Device Related Serious Adverse Events', 'timeFrame': '6 months', 'description': 'The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Test', 'timeFrame': '6 months'}, {'measure': 'Modified Emory Functional Ambulation Profile Total Score', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up \\& Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.'}, {'measure': 'Modified Emory Functional Ambulation Profile Floor Time', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.'}, {'measure': 'Modified Emory Functional Ambulation Profile Carpet Time', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .'}, {'measure': 'Modified Emory Functional Ambulation Profile Timed up and Go', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.'}, {'measure': 'Modified Emory Functional Ambulation Profile Obstacle Course', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.'}, {'measure': 'Modified Emory Functional Ambulation Profile Stair Time', 'timeFrame': '6 months', 'description': 'The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .'}, {'measure': 'Berg Balance Scale', 'timeFrame': '6 months', 'description': 'The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '24526708', 'type': 'RESULT', 'citation': 'Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2014 Sep;28(7):688-97. doi: 10.1177/1545968314521007. Epub 2014 Feb 13.'}, {'pmid': '25653225', 'type': 'DERIVED', 'citation': 'Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy T, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):911-22. doi: 10.1177/1545968315570325. Epub 2015 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.', 'detailedDescription': 'This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient history of stroke (ischemic and/or hemorrhagic).\n* Patient is at least 6 months post stroke.\n* Patient has hemiplegia/hemiparesis.\n* Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance.\n* Patient is not currently using Functional Electrical Stimulation for the treatment of footdrop.\n* Patient is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation on the lower extremity.\n* Patient is a minimum of 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement).\n* Patient is a minimum of 90 days post myocardial infarction.\n* Patient is a minimum of 90 days post stenting procedure (i.e. peripheral, cardiac, carotid, and/or renal).\n* Patient is a minimum of 6 months post CABG or cardiac valve procedure.\n* Patient is able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device).\n* Patient has an initial gait speed \\> 0.0 m/s and \\< 0.8 m/s.\n* Patient has a positive response to peroneal nerve stimulation testing, resulting adequate dorsiflexion of the ankle.\n* Patient has adequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score \\>17 within 30 days prior to enrollment.\n* Patient has completed a full neurological assessment within 30 days prior to enrollment.\n* Patient is eligible for Medicare or Medicare Choice/Advantage benefits at the time of enrollment\n* Patient is able and willing to comply with study procedures, including follow-up requirements.\n* Patient is able and willing to give written informed consent.\n\nExclusion Criteria\n\n* Patient is less than 6-months post stroke.\n* Patient has inadequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score \\< 17 within 30 days prior to enrollment.\n* Patient has ankle joint instability other than foot drop.\n* Patient is less than 30 days post inpatient or outpatient: stroke, cardiac, pulmonary, or any type of physical rehabilitation on the lower extremity at time of enrollment.\n* Patient has need for an AFO for stance control of the foot, ankle and/or knee.\n* Patient has an initial gait speed of 0.8 m/s or greater classified as a full community walker (independent in all home and community activities).\n* Patient is not able to safely clear toes in swing phase on the involved lower extremity, defined as \\>-5° plantar flexion, with the device determined at fitting visit.\n* Patient has been diagnosed with peripheral neuropathy and symptoms obstruct or limit ambulation or participation in study procedures.\n* Patient has been diagnosed with significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication.\n* Patient has underlying condition(s) that would limit study participation such as severe hypertonicity resulting in the need for more involved orthotic strategies or excessive dysesthetic pain secondary to neurological involvement.\n* Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).\n* Patient is NYHA Class III or IV.\n* Patient has malignant skin lesion below the knee on the affected lower extremity.\n* Patient has history of seizure disorder and on seizure medications.\n* Patient has aphasia, defined as incapacity to verbalize commands.\n* Patient has Beck Depression Index score of \\> 29 indicating severe depression.\n* Patient has a life expectancy less than 12 months.\n* Patient has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation, TENS).\n* Patient is less than 6 months free from Botulinum Toxin (Botox) injection in the lower extremity.\n* Patient has baclofen pump with unstable dosing in the last 3 months.\n* Patient is unable or unwilling to comply with study procedures, including follow-up requirements.\n* Patient is participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results.\n* Patient is unable or unwilling to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT01087957', 'briefTitle': 'WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Neurotronics'}, 'officialTitle': 'Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)', 'orgStudyIdInfo': {'id': 'INSTRIDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ankle-Foot Orthosis (AFO)', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'interventionNames': ['Other: Ankle-Foot Orthosis (AFO)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WalkAide', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'interventionNames': ['Device: WalkAide']}], 'interventions': [{'name': 'WalkAide', 'type': 'DEVICE', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'armGroupLabels': ['WalkAide']}, {'name': 'Ankle-Foot Orthosis (AFO)', 'type': 'OTHER', 'description': 'Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)', 'armGroupLabels': ['Ankle-Foot Orthosis (AFO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92534', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'The Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Los Angeles VA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91769', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Casa Colina Centers for Rehabilitation', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'The San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Halifax Hospital', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital NORI', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60187', 'city': 'Wheaton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Marianjoy Rehabilitation', 'geoPoint': {'lat': 41.86614, 'lon': -88.10701}}, {'zip': '55404', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cardinal Hill Rehabilitation', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': "St. Mary's of Michigan", 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Twin-Cities', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Madonna Rehabilitation Hospital', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation Research Center', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '13790', 'city': 'Johnson City', 'state': 'New York', 'country': 'United States', 'facility': 'United Healthcare', 'geoPoint': {'lat': 42.11563, 'lon': -75.95881}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore Neurologic Associates', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10993', 'city': 'West Haverstraw', 'state': 'New York', 'country': 'United States', 'facility': 'Health Research Inc./Helen Hayes Hospital', 'geoPoint': {'lat': 41.20954, 'lon': -73.98542}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Guilford Neurologic Associates', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth of the Carolinas', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Rehabilitation Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "St. David's Rehabilitation Hospital", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Dallas VA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Francois Bethoux, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Neurotronics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}