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Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333580
First received: June 2, 2006
Last updated: August 29, 2008
Last verified: August 2008
History of Changes

June 2, 2006
August 29, 2008
July 2006
June 2008   (final data collection date for primary outcome measure)
Narrative from qualitative interviews and ethnographic analysis of video diaries. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00333580 on ClinicalTrials.gov Archive Site
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Veteran-Centered Outcomes Using Qualitative and Quantitative Methods
Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

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.

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.
Observational
Time Perspective: Prospective
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Non-Probability Sample

Veteran and non-veteran male/females with stroke or incomplete spinal cord injury currently enrolled in locomotor/gait training studies.
  • Spinal Cord Injury
  • Stroke
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1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00333580
O4052X, IRB 03-2006
No
Velozo, Craig - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
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Principal Investigator: Craig A. Velozo, PhD MS BS North Florida/South Georgia Veterans Health System
Department of Veterans Affairs
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP