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Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00333580
Enrollment
15
Registered
2006-06-06
Start date
2006-07-31
Completion date
2008-06-30
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury, Stroke

Keywords

Ethnography, Psychometrics, Qualitative Research

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 (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.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Narrative from qualitative interviews and ethnographic analysis of video diaries.3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026