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Foot-PAD trial statistical analysis plan, Version 6.0
Working paper - Statistical Analysis Plan   Open access

Foot-PAD trial statistical analysis plan, Version 6.0

Adrian J Esterman and Christopher Askew
University of the Sunshine Coast
2021
DOI:
https://doi.org/10.25907/00855
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Stats plan_Foot-PAD SAP v6.0 16Dec2024468.99 kBDownloadView
Published Version Open Access

Abstract

To compare the effect of a 12-Week home program of footplate neuromuscular electrical stimulation (Revitive®, footplate NMES) against a footplate placebo control (PCON) in addition to usual care, on change in maximum walking distance during the six-minute walk test, measured at Baseline, Week 6 and Week 12, in people with peripheral artery disease (PAD). Change in maximum walking distance (MWD) during the 6MWT between Baseline and Week 12 is the primary outcome for the trial. The null hypothesis of no difference between groups at 12 Weeks will be tested.

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