Veteran-Centered Outcomes Using Qualitative and Quantitative Methods
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Purpose
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 |
|---|
|
Spinal Cord Injury Stroke |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Veteran-Centered Outcomes Using Qualitative and Quantitative Methods |
- Narrative from qualitative interviews and ethnographic analysis of video diaries. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Veteran and non-veteran male/females with stroke or incomplete spinal cord injury currently enrolled in locomotor/gait training studies.
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| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Craig A. Velozo, PhD MS BS | North Florida/South Georgia Veterans Health System |
More Information
No publications provided
| Responsible Party: | Velozo, Craig - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00333580 History of Changes |
| Other Study ID Numbers: | O4052X, IRB 03-2006 |
| Study First Received: | June 2, 2006 |
| Last Updated: | August 29, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Ethnography Psychometrics Qualitative Research |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Stroke Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |
Wounds and Injuries Cerebrovascular Disorders Brain Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013