Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT01896466
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2013-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Gait and Balance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Gait Index', 'timeFrame': 'Day 1 and approximately Day 12', 'description': 'An 8-item inventory of functional gait tasks each scored on a 0-3 point scale. Maximum score is 24 and any score of 19 or lower indicates an increased risk of falling.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fall Risk', 'Gait', 'Dynamic Balance', 'Static Balance', 'Neuromodulation'], 'conditions': ['Aging', 'Accidental Falls']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is twofold:\n\n1. Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.\n2. Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.\n\nFor the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community-dwelling\n* Able to understand and give informed consent\n* Able to stand and walk independently without an assistive device\n* No contraindication to exercise\n\n 1\\. Healthy young adults\n* Between ages of 18 and 39\n* Scores above 19 on Dynamic Gait Index 2. Healthy older adults without a history of falls\n* Age 65+\n* Scores above 19 on Dynamic Gait Index 3. Older adults with a history of falls\n* Age 65+\n* Self-reported history of 1-3 falls in previous year\n* Scores of 19 and below on the Dynamic Gait Index\n\nExclusion Criteria:\n\n* History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)\n* Use of tobacco products\n* Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months\n* Have a pacemaker or are identified as at-risk for cardiovascular events\n* Have a biomechanical prosthetic\n* If female, self-report of being pregnant\n* Neurological condition\n* Prisoners\n* Individuals clearly lacking the capacity to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01896466', 'briefTitle': 'Enhanced Gait and Balance Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Influence of Neuromodulation on Gait and Balance', 'orgStudyIdInfo': {'id': '2013-0394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Young Adults - Intervention', 'description': 'Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training.', 'interventionNames': ['Device: Cranial Nerve Non-Invasive Neuromodulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Older Adults - Control', 'description': 'Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.', 'interventionNames': ['Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Older Adults - Intervention', 'description': 'Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.', 'interventionNames': ['Device: Cranial Nerve Non-Invasive Neuromodulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Older Fallers - Control', 'description': 'Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.', 'interventionNames': ['Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Older Fallers - Intervention', 'description': 'Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.', 'interventionNames': ['Device: Cranial Nerve Non-Invasive Neuromodulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Young Adult - Control', 'description': 'Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.', 'interventionNames': ['Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation']}], 'interventions': [{'name': 'Cranial Nerve Non-Invasive Neuromodulation', 'type': 'DEVICE', 'otherNames': ['PoNS (Portable Neuromodulation Stimulator)'], 'description': 'Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance.', 'armGroupLabels': ['Healthy Older Adults - Intervention', 'Older Fallers - Intervention', 'Young Adults - Intervention']}, {'name': 'Sham Cranial Nerve Non-Invasive Neuromodulation', 'type': 'BEHAVIORAL', 'description': 'Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.', 'armGroupLabels': ['Healthy Older Adults - Control', 'Older Fallers - Control', 'Young Adult - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Darryl G Thelen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}