Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-03-26 @ 6:12 PM
Study NCT ID:
NCT02507466
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Intensive Variable Repetitive AmbulatioN Training
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 arm RCT - high intensity variable, high intensity forward, low intensity variable'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak walking speed', 'timeFrame': 'At baseline, following 8 weeks of training and a 2 month follow-up', 'description': 'fastest comfortable walking speed overground'}], 'secondaryOutcomes': [{'measure': 'Change in Functional Gait Assessment', 'timeFrame': 'At baseline, following 8 weeks of training and a 2 month follow-up', 'description': 'dynamic balance activities'}, {'measure': 'Change in 5X sit-to-stand transfer time', 'timeFrame': 'At baseline, following 8 weeks of training and a 2 month follow-up', 'description': 'non-walking functional mobility task'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['locomotion'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34695300', 'type': 'DERIVED', 'citation': 'Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.'}, {'pmid': '32883192', 'type': 'DERIVED', 'citation': 'Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.'}, {'pmid': '32507027', 'type': 'DERIVED', 'citation': 'Ardestani MM, Henderson CE, Mahtani G, Connolly M, Hornby TG. Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. Neurorehabil Neural Repair. 2020 Jul;34(7):652-660. doi: 10.1177/1545968320929675. Epub 2020 Jun 6.'}, {'pmid': '31434543', 'type': 'DERIVED', 'citation': 'Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.', 'detailedDescription': 'The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history unilateral stroke \\> 6 months duration\n* walks without physical assistance at speeds \\< 1.0 m/s\n\nExclusion Criteria:\n\n* no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes'}, 'identificationModule': {'nctId': 'NCT02507466', 'acronym': 'VIVRANT', 'briefTitle': 'Very Intensive Variable Repetitive AmbulatioN Training', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Very Intensive Variable Repetitive AmbulatioN Training', 'orgStudyIdInfo': {'id': 'STU00103739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Variable high-intensity Training', 'description': 'high intensity variable stepping exercise on a treadmill and overground', 'interventionNames': ['Behavioral: exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Variable low-intensity training', 'description': 'low intensity variable stepping exercise on a treadmill and overground', 'interventionNames': ['Behavioral: exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Constant High Intensity Training', 'description': 'high intensity constant (forward) stepping exercise on a treadmill and overground', 'interventionNames': ['Behavioral: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'Variable conditions of stepping practice', 'armGroupLabels': ['Constant High Intensity Training', 'Variable high-intensity Training', 'Variable low-intensity training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Thomas Hornby, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RIC/NU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Thomas G Hornby', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}