Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-30 @ 8:01 AM
Study NCT ID:
NCT01138995
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020427', 'term': 'Peroneal Neuropathies'}, {'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Keith.McBride@bioness.com', 'phone': '661-362-4866', 'title': 'Keith McBride, CTO', 'organization': 'Bioness'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.', 'otherNumAtRisk': 98, 'otherNumAffected': 61, 'seriousNumAtRisk': 98, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 30 weeks.\n\nThe Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.', 'otherNumAtRisk': 99, 'otherNumAffected': 82, 'seriousNumAtRisk': 99, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'localized skin redness, rash, irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 68, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation and hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seasonal allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertonia, headache, dizziness, memory deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea or abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension and/or flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 33, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fear or depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gout or diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation or abnormal heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'asthma, cough, bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'blister, folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fall with or without injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 71, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 81, 'numAffected': 56}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'stroke/high blood pressure', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cholecystectomy', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia/respiratory', 'notes': 'non-device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cancer', 'notes': 'non-device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone fracture', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemiparesis', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'kidney damage due to dehydration', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia requiring blood transfusion', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ovarian mass', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bowel obstruction', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'methicillin resistant Staphylococcus aureus', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mental depression and anxiety', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization general complaints', 'notes': 'non device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ten Meter Walk Test (10mWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.'}, {'id': 'OG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 30 weeks.\n\nThe Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "Fisher's combination test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Between group difference for entire sample', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 30', 'description': 'Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.', 'unitOfMeasure': 'meters per second (m/s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Berg Balance Scale (BBS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.'}, {'id': 'OG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 30 weeks.\n\nNess L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '6.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.022', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 30', 'description': 'Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.'}, {'type': 'SECONDARY', 'title': 'User Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.'}, {'id': 'OG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 30 weeks.\n\nThe Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 30', 'description': 'Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.\n\nNess L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.\n\nNess L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.'}, {'id': 'FG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 42 weeks.\n\nNess L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.\n\nNess L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Originial Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.\n\nNess L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.\n\nNess L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.'}, {'id': 'BG001', 'title': 'Original Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 42 weeks.\n\nNess L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.\n\nNess L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '197', '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': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2010-06-04', 'resultsFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-28', 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ten Meter Walk Test (10mWT)', 'timeFrame': 'Week 30', 'description': 'Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale (BBS) Score', 'timeFrame': 'Week 30', 'description': 'Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.'}, {'measure': 'User Satisfaction', 'timeFrame': 'Week 30', 'description': 'Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Poststroke/CVA hemiparesis', 'Drop Foot', 'Gait Disorders, Neurological', 'Gait, Drop foot'], 'conditions': ['Sensorimotor Gait Disorder', 'Neurologic Ambulation Disorder', 'Gait, Drop Foot', 'Poststroke Hemiparesis', 'Post-Cerebrovascular Accident (CVA) Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '29288141', 'type': 'DERIVED', 'citation': "Alenazi AM, Alshehri MM, Alothman S, Rucker J, Dunning K, D'Silva LJ, Kluding PM. Functional Reach, Depression Scores, and Number of Medications Are Associated With Number of Falls in People With Chronic Stroke. PM R. 2018 Aug;10(8):806-816. doi: 10.1016/j.pmrj.2017.12.005. Epub 2017 Dec 26."}, {'pmid': '24412265', 'type': 'DERIVED', 'citation': "O'Dell MW, Dunning K, Kluding P, Wu SS, Feld J, Ginosian J, McBride K. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. 2014 Jul;6(7):587-601; quiz 601. doi: 10.1016/j.pmrj.2014.01.001. Epub 2014 Jan 9."}, {'pmid': '23640829', 'type': 'DERIVED', 'citation': "Kluding PM, Dunning K, O'Dell MW, Wu SS, Ginosian J, Feld J, McBride K. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke. 2013 Jun;44(6):1660-9. doi: 10.1161/STROKEAHA.111.000334. Epub 2013 May 2."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.', 'detailedDescription': 'Approximately 176 subjects with stroke that have drop foot will be enrolled from approximately 10 different sites in the United States depending on the rate of enrollment. This clinical study is proposed to show that the functional electrical stimulation (FES) delivered via the Ness L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have ankle dorsiflexion range of motion greater than or equal to neutral when assessed concurrent with test stimulation in sitting and standing and demonstrate adequate ankle and knee stability during gait at the time of screening\n* Have had at least one stroke of any etiology (e.g., ischemic, hemorrhagic,etc.) experienced greater than or equal to 3 months prior to study enrollment, as confirmed by independent medical records, and result in drop foot sufficient to require prior or current prescription for and/or use of an AFO\n* Have adequate cognition and communication abilities for informed consent, training and instructions, use of the L300, and provide feedback, to be demonstrated by either the subjects scoring greater than or equal to 24 (out of a possible 30) on the Mini Mental State Examination, or having a competent caregiver for these purposes\n* Must be 18 years or older\n* Have the ability to safely walk at least 10-meters with a maximum of 1 person assist\n* Have a self-selected 10-meter gait speed of less than or equal to 0.8m/s at the time of assessment\n* Have inadequate dorsiflexion/limb clearance or unable to achieve normal heel strike on ambulation without AFO\n* Be medically stable\n\nExclusion Criteria:\n\n* Have fixed ankle contracture at greater than or equal to 5 degrees of plantar flexion in the hemiplegic leg with the knee extended\n* Have excessive pain in the affected leg, as measured by a score greater than or equal to 4 on a 10-point visual analog scale\n* Participation, within the past 3 months, currently, or during the course of the study in any interventional clinical studies without the Sponsor's approval\n* Have a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant\n* Have a lower motor neuron disease or injury with inadequate response to stimulation\n* Have significant swelling/edema in the leg extending up to the knee\n* Have a history of chronic skin problems/conditions or cancerous lesion present or suspected in close proximity ot the expected site for L300 stimulation\n* Are pregnant or plan on becoming pregnant in the next 45 weeks\n* Have had botulinum toxin(type a or b) to the hemiplegic leg or arm within the past six weeks or plan to have botulinum toxin treatments during the course of the study\n* Expectation of a significant change in the subject's spasticity medications during the course of the study for the effected leg\n* Have unstable seizure disorder (average of greater or equal to 2 seizures per month)\n* Have a pre-existing significant orthopedic conditions that are, a that investigator's discretion, determined as likely to limit ambulatory progress (e.g., total hip replacement \\[non-metallic\\], total knee replacement \\[non-metallic\\], limited lower extremity (LE) range of motion (ROM), rheumatoid arthritis, osteoarthritis, or other fracture or dislocation that underlies the expected site for L300 stimulation)\n* Have a complete hemisensory loss ipsilateral to foot drop\n* Used the L300 or other FES device for foot drop (e.g., Odstock Drop Foot System (ODFS), WalkAide by Innovation Neurotronics, etc.) for greater than or equal to 3 hours within the last 6 months prior to study enrollment\n* Have major post-stroke depression (PHQ-9 greater than or equal to 10) that is not medically managed with antidepression medication and/or psychotherapy\n* Currently or planning on participating in a neuro-rehabilitation physical therapy (PT) or occupational therapy (OT) program or new independent exercise programs with enrolled in the study. However, injury or a change in condition requiring PT or OT that would not affect gait outcomes maybe assessed by an off-site study committee, on a case-by-case basis"}, 'identificationModule': {'nctId': 'NCT01138995', 'acronym': 'L300', 'briefTitle': 'Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioness Inc'}, 'officialTitle': 'Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop', 'orgStudyIdInfo': {'id': 'CP-L300-0801, Rev. B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ankle-foot orthosis (AFO) Control Group', 'description': 'The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.', 'interventionNames': ['Device: Ankle-foot orthosis']}, {'type': 'EXPERIMENTAL', 'label': 'Ness L300 Treatment Group', 'description': 'The Original Treatment Group will walk with the Ness L300 for 30 weeks.', 'interventionNames': ['Device: Ness L300']}], 'interventions': [{'name': 'Ness L300', 'type': 'DEVICE', 'otherNames': ['Leg Stimulator'], 'description': 'The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.', 'armGroupLabels': ['Ness L300 Treatment Group']}, {'name': 'Ankle-foot orthosis', 'type': 'DEVICE', 'otherNames': ['drop foot orthotic'], 'description': 'The Control Group will walk with a "usual" ankle-foot orthosis (AFO).', 'armGroupLabels': ['Ankle-foot orthosis (AFO) Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242-3496', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos National Rehabilitation Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rehabilitation Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'National Rehabilitation Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Brooks Center for Rehabilitation Studies', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'St.Charles Hospital & Rehabilitation', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '45216', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Drake Center /University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75390-9055', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kari Dunning, PT, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'The Drake Center/University of Cincinnati'}, {'name': "Michael O'Dell, MD", 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'Patricia Kluding, PT, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}, {'name': 'Steven R. Edgley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}, {'name': 'Kathaleen P Brady, PT, NCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar National Rehabilitation Network'}, {'name': 'Trevor Paris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brooks Rehabilitation'}, {'name': 'Jerome Stenehjem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp Rehabilitation Center'}, {'name': 'John Thottakara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}, {'name': 'Jun Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Charles Hospital & Rehabilitation'}, {'name': 'Ziyad Ayyoub, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rancho Los Amigos National Rehabilitation'}, {'name': 'Diemha Hoang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Long Beach Memorial Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioness Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medidata Solutions', 'class': 'INDUSTRY'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}