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
  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

Resource links provided by NLM:


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.

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333580

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
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
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014