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Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00333580
Collaborator
(none)
15
Enrollment
1
Location
23
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 (RLT)and 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 grant)will 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 Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Time Perspective:
    Prospective
    Official Title:
    Veteran-Centered Outcomes Using Qualitative and Quantitative Methods
    Study Start Date :
    Jul 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Outcome Measures

    Primary Outcome Measures

    1. Narrative from qualitative interviews and ethnographic analysis of video diaries. [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with stroke and patients with incomplete spinal cord injuries currently enrolled in locomotor/gait training studies at the VA BRain Rehabilitation Research Center, Gainesville, FL and the VA Functional Electrical Stimulation Center, Cleveland, Ohio, Competence for inclusion in the treatment intervention study (and the present study) is passing the 3-step command component of the Mini Mental Status Exam.
    Exclusion Criteria:
    • Unable to pass the 3-step command component of the Mini-Mental Exam.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Florida/South Georgia Veterans Health System Gainesville Florida United States 32608

    Sponsors and Collaborators

    • US Department of Veterans Affairs

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00333580
    Other Study ID Numbers:
    • O4052-X
    • IRB 03-2006
    First Posted:
    Jun 6, 2006
    Last Update Posted:
    Apr 8, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by US Department of Veterans Affairs
    Ethnography
    Psychometrics
    Qualitative Research
    Additional relevant MeSH terms:
    Spinal Cord Injuries

    Study Results

    No Results Posted as of Apr 8, 2015