The Walkability Post Stroke Study
Research type
Research Study
Full title
The Walkability Post Stroke Study: developing a patient-reported outcome measure of walking ability for use in stroke clinical trials
IRAS ID
177075
Contact name
Jeremy Charles Hobart
Contact email
Sponsor organisation
Plymouth Hospitals NHS trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The aim of this study is to develop a self-report questionnaire for measuring walking ability after stroke. The aim is also that this “Walkability” patient-reported outcome measure (PRO) satisfies scientific and regulatory (US Food and Drug Administration and European Medicines Agency) criteria for use as a primary outcome measure in stroke clinical trials. The study has two stages.
Stage 1 is qualitative research (interviews) in people with walking problems after stroke. The aim of this qualitative research, which builds on existing market research interviews and ongoing literature examinations, is to develop a questionnaire for reliability and validity testing (Stage 2). Potential participants will be identified by the Plymouth branch of the Stroke Association from their database, and from Derriford Hospital records. Three rounds of qualitative research, each round consisting of n˜30 interviews, are anticipated to produce a final version of the questionnaire.
Stage 2 is a postal survey of the final version of the post stroke Walkability PRO, administered with other scales, to a large sample of stroke survivors. Participants will be identified from two cohorts of stroke survivors: the Plymouth branch of the stroke association, and from Derriford Hospital records. Questionnaire response data will be analysed using state-of-the art methods for testing scale's reliability and validity (Rasch Measurement Theory, RMT). In order to estimate the approach sample size needed for the survey we will conduct preliminary surveys of two scales in the two cohorts above.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0198
Date of REC Opinion
26 Feb 2015
REC opinion
Favourable Opinion