Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-28 @ 4:20 PM
Study NCT ID:
NCT01225432
Status:
UNKNOWN
Last Update Posted:
2010-10-21
First Post:
2010-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2010-10-19', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Oxygen Consumption', 'timeFrame': '3 weeks'}, {'measure': 'Gait Oxygen Consumption', 'timeFrame': 'Immediately prior to start of 3 week training.'}, {'measure': 'Gait Oxygen Consumption', 'timeFrame': 'Immediately post training'}, {'measure': 'Gait Oxygen Consumption', 'timeFrame': '3 weeks later from first post training testing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elevated Metabolic Cost']}, 'descriptionModule': {'briefSummary': 'To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Unilateral traumatic trans-tibial or transfemoral amputation\n* Independent ambulation without an assistive device for a minimum of three months\n* Ability to ambulate continuously for a minimum of 15 minutes\n* Trans-femoral participants must use an ischial containment socket\n* VAS Pain scores on the involved side of less than 4/10\n* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.\n\nExclusion Criteria:\n\n* Blindness\n* TBI-Glascow Coma Scale score of 12 or lower at the time of injury\n* Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.'}, 'identificationModule': {'nctId': 'NCT01225432', 'acronym': 'VRVO2', 'briefTitle': 'The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation', 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation', 'orgStudyIdInfo': {'id': 'C.2008.050dt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gait Training', 'interventionNames': ['Other: Gait Training']}], 'interventions': [{'name': 'Gait Training', 'type': 'OTHER', 'description': '12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.', 'armGroupLabels': ['Gait Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for the Intrepid', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}], 'overallOfficials': [{'name': 'Jason M Wilken, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Military Performance Lab-Center for the Intrepid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Jason M. Wilken PT, PhD', 'oldOrganization': 'Brooke Army Medical Center'}}}}