Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

This study has been completed.
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: June 2, 2006
Last updated: September 29, 2014
Last verified: September 2014

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.

Spinal Cord Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00333580

United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
  More Information

Responsible Party: Department of Veterans Affairs Identifier: NCT00333580     History of Changes
Other Study ID Numbers: O4052-X, IRB 03-2006
Study First Received: June 2, 2006
Last Updated: September 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Qualitative Research processed this record on March 03, 2015