Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT00013494
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-Based Functional Performance and Assessment Following Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071939', 'term': 'Stroke Rehabilitation'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2001-03-14', 'studyFirstSubmitQcDate': '2001-03-15', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-03-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Hemiplegia', 'elderly', 'Video', 'F-PAT,Functional Performance', 'digitized videoclips'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of physical function.\n\nThis project will develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.', 'detailedDescription': "For people who have become hemiplegic as a result of a stroke, a critical safety-related retraining area for physical functions is wheelchair transfers. In addition, to incorporate the relatively unsupervised home care into the rehabilitation process, clinicians require a better means to assess functional gains and provide effective training tools. Our goal is to develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training) which relies on the manipulation of digitized videoclips. Our development objectives are (1) to enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) to train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. Our clinical objective is to implement a 2-year evaluation of the F-PAT design concept with 30 subjects, divided in 3 groups, who as patients undergo acute rehabilitation at the VA Comprehensive Rehabilitation Center and are discharged to their homes or a sub-acute facility. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.\n\nThe study will divide the subjects into three treatment groups to compare the effectiveness of accepted practice, generic videotape, and personalized videotape home-based instruction for clients and care providers. Comparison of outcomes will be done using videotape of task performance before release from the acute therapy program and at the follow-up evaluation one month later. The subjects will be evaluated by a blinded physiatrist viewing and rating digitized videoclips of task performance on the F-PAT web site. This study will determine if personalized videoclip-based instructional material is effective, and if videoclip comparisons by a clinician is an effective diagnosis and assessment instrument. If it is not possible for logistical reasons for a subject to return to the clinic for the follow-on evaluation, the F-PAT team will visit the subject's home and perform the videotaping on-site. The remainder of the evaluation with input from the physiatrist will occur subsequently at the clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Hemiplegic patients'}, 'identificationModule': {'nctId': 'NCT00013494', 'briefTitle': 'Video-Based Functional Performance and Assessment Following Stroke', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Video-Based Functional Performance and Assessment Following Stroke', 'orgStudyIdInfo': {'id': 'E2169T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stroke Rehabilitation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VAMC, Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'John Fryer, Ph.D., Asst. Director', 'affiliation': 'Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}, {'name': 'Victoria Mongiardo, Program Analyst', 'affiliation': 'Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}}}}