Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 7:30 AM
Study NCT ID:
NCT03530592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2018-05-21
First Post:
2018-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D020427', 'term': 'Peroneal Neuropathies'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020422', 'term': 'Mononeuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Seated Ankle Robot Taining'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle dorsiflexion-plantarflexion range of motion', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'degrees'}, {'measure': 'Ankle inversion-eversion range of motion', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'degrees'}, {'measure': 'Gait velocity during self-selected overground walking', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'cm/sec'}, {'measure': 'Postural sway areas during quiet standing', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'cm\\^2; extent of postural deviations to assess static postural control'}, {'measure': 'Ratio of asymmetric loading in quiet standing', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'ratio of Newtons of force per leg while standing quietly'}, {'measure': 'Push-off forces during gait initiation', 'timeFrame': 'Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training', 'description': 'Newtons; magnitude of forward ground reaction forces.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Nervous System Diseases', 'Gait Disorders, Neurologic', 'Foot Drop', 'Mobility Limitation']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.', 'detailedDescription': 'Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.\n\nThis study will focus on PNS injuries that cause foot drop.\n\nCurrent therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.\n\nThe investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators\' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women, aged 18 to 88 years\n2. Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury\n3. Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device\\[s\\] is permitted)\n\nExclusion Criteria:\n\n1. Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation\n2. Current participation in orthopedic or rehabilitation medical programs\n3. Active deep venous thrombosis\n4. Distal paretic leg skin lesions, infections, or soft tissue inflammation'}, 'identificationModule': {'nctId': 'NCT03530592', 'briefTitle': 'Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project', 'organization': {'class': 'FED', 'fullName': 'Baltimore VA Medical Center'}, 'officialTitle': 'Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project', 'orgStudyIdInfo': {'id': 'HP-68734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seated Ankle Robot Training', 'interventionNames': ['Device: Seated Ankle Robot Training']}], 'interventions': [{'name': 'Seated Ankle Robot Training', 'type': 'DEVICE', 'description': 'This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.', 'armGroupLabels': ['Seated Ankle Robot Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Kate C. Flores', 'role': 'CONTACT'}, {'name': 'Charlene E. Hafer-Macko, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Kate C. Flores', 'role': 'CONTACT', 'email': 'kate.flores@va.gov', 'phone': '(410) 637-3242'}], 'overallOfficials': [{'name': 'Charlene E. Hafer-Macko, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baltimore VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baltimore VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Charlene Elaine Hafer-Macko', 'investigatorAffiliation': 'Baltimore VA Medical Center'}}}}