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Unloading shoes for intermittent claudication: a randomised crossover trial

Tew, Garry, Shalan, Ahmed, Jordan, Alastair, Cook, Liz, Fairhurst, Caroline, Coleman, Elizabeth, Hewitt, Catherine, Hutchins, Stephen and Thompson, Andrew (2017) Unloading shoes for intermittent claudication: a randomised crossover trial. BMC Cardiovascular Disorders, 17 (283).

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Abstract

Background: The purpose of this study was to assess the functional effects and acceptability of rocker-soled shoes that were designed to relatively “unload” the calf muscles during walking in people with calf claudication due to peripheral arterial disease.
Methods: In this randomised AB/BA crossover trial, participants completed two assessment visits up to two weeks apart. At each visit, participants completed walking tests whilst wearing the unloading shoes or visually-similar control shoes. At the end of the second visit, participants were given either the unloading or control shoes to use in their home environment for 2 weeks, with the instruction to wear them for at least 4 hours every day. The primary outcome was 6-minute walk distance. We also assessed pain-free walking distance and gait biomechanical variables during usual-pace walking, adverse events, and participants’ opinions about the shoes. Data for continuous outcomes are presented as mean difference between conditions with corresponding 95% confidence interval.
Results: Thirty-four participants (27 males, mean age 68 years, mean ankle-brachial index 0.54) completed both assessment visits. On average, the 6-minute walk distance was 11 m greater when participants wore the control shoes (95% CI -5 to 26), whereas mean pain-free walking distance was 7 m greater in the unloading shoes (95% CI -17 to 32). Neither of these differences were statistically significant (p=0.18 and p=0.55, respectively). This was despite the unloading shoes reducing peak ankle plantarflexion moment (mean difference 0.2 Nm/kg, 95% CI 0.0 to 0.3) and peak ankle power generation (mean difference 0.6 W/kg, 95% CI 0.2 to 1.0) during pain-free walking. The survey and interview data was mixed, with no clear differences between the unloading and control shoes.
Conclusions: Shoes with modified soles to relatively unload the calf muscles during walking conferred no substantial acute functional benefit over control shoes.
Trial Registration: Clinicaltrials.gov, Trial Registration Number: NCT02505503, First registered 22 July 2015.

Item Type: Article
Status: Published
DOI: https://doi.org/10.1186/s12872-017-0716-x
Subjects: R Medicine > R Medicine (General)
School/Department: School of Sport
URI: http://ray.yorksj.ac.uk/id/eprint/2635

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