Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 5:13 PM
Study NCT ID:
NCT02043834
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-based Exercise in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural Balance', 'timeFrame': 'after 4 weeks', 'description': 'Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technologies (BalanSens™)'}], 'secondaryOutcomes': [{'measure': 'Gait performance', 'timeFrame': '4 weeks', 'description': 'Gait performance will be measured using validated wearable sensor technology (LEGSys™)'}, {'measure': 'Cognitive status', 'timeFrame': '4 weeks', 'description': 'Changes in cognitive status will be measured by the Trail Making Test and the Category Fluency Test'}, {'measure': 'Quality of life', 'timeFrame': '4 weeks'}, {'measure': 'Functional performance', 'timeFrame': '4 weeks', 'description': 'Functional performance will be assessed using the Timed Up and Go Test and the Alternate Step Test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Distorted; Balance', 'Motor Deficit']}, 'referencesModule': {'references': [{'pmid': '25496052', 'type': 'DERIVED', 'citation': 'Schwenk M, Grewal GS, Honarvar B, Schwenk S, Mohler J, Khalsa DS, Najafi B. Interactive balance training integrating sensor-based visual feedback of movement performance: a pilot study in older adults. J Neuroeng Rehabil. 2014 Dec 13;11:164. doi: 10.1186/1743-0003-11-164.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in older adults.\n\nWe hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in older adults compared to a control group receiving usual care only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to ambulate without assistance\n* willingness to provide informed consent\n\nExclusion Criteria:\n\n* severe neurologic, cardiovascular, metabolic, or psychiatric disorders\n* severe visual impairment\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT02043834', 'briefTitle': 'Virtual Reality-based Exercise in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Promoting Virtual Reality-based Exercise to Prevent Falls in Older Adults: Pilot Study', 'orgStudyIdInfo': {'id': 'ARPF-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance Training', 'description': 'Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.', 'interventionNames': ['Other: Balance Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will keep their normal activity without receiving any intervention.'}], 'interventions': [{'name': 'Balance Training', 'type': 'OTHER', 'description': 'Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.', 'armGroupLabels': ['Balance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Villa Hermosa - Senior Living Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Bijan Najafi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizona'}, {'name': 'Michael Schwenk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}