Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT01182961
Status:
UNKNOWN
Last Update Posted:
2010-08-30
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Virtual Reality for the Gait Training of Elderly Fallers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-27', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait dynamics', 'timeFrame': 'one week after training', 'description': 'using an accelerometer, the coefficient of variation will be calculated'}], 'secondaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': 'one week after training', 'description': 'using a cmputerized cognitive battary and neuropsychological testing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gait', 'Falls', 'Virtual reality'], 'conditions': ['Elderly']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.', 'detailedDescription': 'The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 65-85\n* independent in activities of daily living\n* able to walk without assistance for at least 10 minutes\n* cognitively intact (Mini Mental State Exam ≥24)\n* reported 2 or more falls within 6 months prior to the beginning of the study\n\nExclusion Criteria:\n\n* any neurological, orthopedic or any other impairment likely to impact gait.\n* severe visual impairments\n* major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria'}, 'identificationModule': {'nctId': 'NCT01182961', 'acronym': 'VR-Fallers', 'briefTitle': 'The Use of Virtual Reality for the Gait Training of Elderly Fallers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population', 'orgStudyIdInfo': {'id': 'TASMC-10-NG-0113-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill +virtual reality training', 'interventionNames': ['Other: gait training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill alone', 'interventionNames': ['Other: gait training 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care exercise group', 'interventionNames': ['Other: exercise group']}], 'interventions': [{'name': 'gait training', 'type': 'OTHER', 'otherNames': ['virtual reality'], 'description': 'subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device', 'armGroupLabels': ['Treadmill +virtual reality training']}, {'name': 'gait training 2', 'type': 'OTHER', 'otherNames': ['treadmill'], 'description': 'subjects will walk on a treadmill under a progressive intensive gait protocol', 'armGroupLabels': ['Treadmill alone']}, {'name': 'exercise group', 'type': 'OTHER', 'description': 'standard of care exercise group to improve strength and balance', 'armGroupLabels': ['standard of care exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Anat Mirelman, PhD', 'role': 'CONTACT', 'email': 'anatmi@tasmc.health.gov.il', 'phone': '+972 3 6974958'}, {'name': 'Nir Giladi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anat Mirelman, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Anat Mirelman, PhD', 'role': 'CONTACT', 'email': 'anatmi@tasmc.health.gov.il', 'phone': '+972 3 6974958'}], 'overallOfficials': [{'name': 'Nir Giladi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Nir Giladi, MD', 'oldOrganization': 'Tel Aviv University'}}}}