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.

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Key information

Conditions

Spinal Cord Injury Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Narrative from qualitative interviews and ethnographic analysis of video diaries.

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jun 6, 2006
Registry last updated: Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed