Viewing Study NCT00013494



Ignite Creation Date: 2024-05-05 @ 11:22 AM
Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00013494
Status: COMPLETED
Last Update Posted: 2009-01-21
First Post: 2001-03-14

Brief Title: Video-Based Functional Performance and Assessment Following Stroke
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: Video-Based Functional Performance and Assessment Following Stroke
Status: COMPLETED
Status Verified Date: 2006-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: For hemiplegic stroke patients wheelchair transfers is a critical safety-related area of physical function

This 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
Detailed Description: 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

The 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 subjects home and perform the videotaping on-site The remainder of the evaluation with input from the physiatrist will occur subsequently at the clinic

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None