Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-04-03 @ 7:56 AM
Study NCT ID:
NCT01558232
Status:
TERMINATED
Last Update Posted:
2012-07-09
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': "Study was terminated base on Sponsor's decision.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulation Speed', 'timeFrame': 'Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.', 'description': 'Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).'}], 'secondaryOutcomes': [{'measure': 'Measurements of Gait', 'timeFrame': 'Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.', 'description': 'The secondary endpoints are obtained from the GAITRite analysis system:\n\n* Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.'}, {'measure': 'Measurements of Stride', 'timeFrame': 'Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.', 'description': 'Other secondary endpoints are obtained from the GAITRite analysis system:\n\n* Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.'}, {'measure': 'Measurements of Force, Stance, and Stability', 'timeFrame': 'Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.', 'description': 'Other secondary endpoints are obtained from Balance Master system:\n\n* Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Tibion', 'Bionics', 'Rehab', 'Therapy', 'Robotics', 'Intention'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '22082495', 'type': 'BACKGROUND', 'citation': 'Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.'}, {'pmid': '19964374', 'type': 'BACKGROUND', 'citation': 'Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.'}, {'pmid': '17946511', 'type': 'BACKGROUND', 'citation': 'Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.'}], 'seeAlsoLinks': [{'url': 'http://www.tibion.com', 'label': 'Tibion Bionic Leg'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.', 'detailedDescription': 'Samples text.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single stroke with residual unilateral lower-extremity weakness\n* Subacute post-stroke period (\\>3 and \\<12 months)\n* Eligible to participate to lower extremity physical therapy\n* Age 40 years or greater\n* Able to ambulate at least 10 meters\n* Able to ambulate without a leg brace\n* Ambulation speed less than 0.8 meters/second\n* Minimum to moderate assist for transfer or ambulation by physical therapist evaluation\n* Subject must understand the nature of the study and provide written informed consent prior to enrollment.\n* Subject must be willing and able to attend all study sessions\n\nExclusion Criteria:\n\n* Medically unstable\n* Age younger than 40 years\n* Acute post-stroke (\\< 3 months)\n* Chronic post-stroke (\\> 12 months)\n* Status-post multiple strokes\n* Status-post traumatic brain injury\n* Ambulation speed greater than 0.8 meters/second\n* Currently using a Knee-Ankle-Foot Orthosis (KAFO)\n* Not eligible for lower extremity physical therapy\n* Concomitant degenerative neurological conditions\n* Not able to ambulate at least 10 meters without assistance\n* Greater than moderate assist during transfer or ambulation by physical therapist evaluation\n* Unable to ambulate without a leg brace\n* Unable to follow instructions, complete follow-up, or provide informed consent.\n* Currently enrolled in another investigational device or drug trial'}, 'identificationModule': {'nctId': 'NCT01558232', 'acronym': 'Acute Effects', 'briefTitle': 'A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tibion Bionics, Inc.'}, 'officialTitle': 'A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy', 'orgStudyIdInfo': {'id': 'CP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tibion Arm', 'description': 'Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.', 'interventionNames': ['Device: Tibion Bionic Leg']}], 'interventions': [{'name': 'Tibion Bionic Leg', 'type': 'DEVICE', 'description': 'The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).', 'armGroupLabels': ['Tibion Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Rehabilitation Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Barbara Browne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Magee Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tibion Bionics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}