Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Stroke Clinical Trial

Official title:

Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333580
• Other study ID #: O4052-X
• Secondary ID: IRB 03-2006
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: April 7, 2015
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hannold EM, Hanjian JM, Jordan MM, Roach MJ, Velozo CA. Using veterans' perspectives to enhance rehabilitation outcome measures: value of qualitative methods. J Rehabil Res Dev. 2008;45(1):xi-xv. — View Citation

Jordan MM, Berkowitz D, Hannold E, Velozo CA, Behrman AL. Thinking through every step: how people with spinal cord injuries relearn to walk. Qual Health Res. 2013 Aug;23(8):1027-41. doi: 10.1177/1049732313494119. Epub 2013 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narrative from qualitative interviews and ethnographic analysis of video diaries.		3 months	No