Viewing Study NCT00333580



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Study NCT ID: NCT00333580
Status: COMPLETED
Last Update Posted: 2015-04-08
First Post: 2006-06-02

Brief Title: Veteran-Centered Outcomes Using Qualitative and Quantitative Methods
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: Veteran-Centered Outcomes Using Qualitative and Quantitative Methods
Status: COMPLETED
Status Verified Date: 2015-04
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: The purpose of this study is to modify and develop measures that reflect outcomes that are relevant to recovering Veterans and are sensitive to improvements resulting from innovative gait interventions
Detailed Description: Existing clinically-generated measures in general have been developed independent of input from Veterans The purpose of this collaborative study is to take advantage of qualitative and quantitative expertise from the Gainesville Florida Rehabilitation Outcomes Research Center RORC with state-of-the-art gait intervention research being conducted at the Gainesville Brain Rehabilitation Research Center BRRC and Cleveland Functional Electrical Stimulation Center FESC Three interventions have received considerable attention for their demonstrated promise in improving gait and mobility in individuals with spinal cord injury and stroke 1 manually assisted locomotor training MLT 2 robotic assisted locomotor training RLTand 3 functional electrical stimulation assisted gait training FES-GT These interventions will be the basis for improving existing outcome measures and developing new outcome measures The process of developing and evaluating valid outcome measures requires four phases of development This study encompasses Phases I and II Phase I Year 1 of grantwill involve completing qualitative research studies to identify constructs reflecting the impact of MLT RLT and FES-GT on Veterans Data will be systematically collected using ethnographic field observations and in depth semi-structured interviews Phase II Year 2 will involve using the identified constructs to develop item banks for Veterans-centered outcome measures

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
Secondary IDs
Secondary ID Type Domain Link
IRB 03-2006 OTHER University of Florida IRB None