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Randomized Controlled Trial
. 2017 Nov 28;17(1):283.
doi: 10.1186/s12872-017-0716-x.

Unloading shoes for intermittent claudication: a randomised crossover trial

Garry A Tew  1 , Ahmed Shalan  2 , Alastair R Jordan  3 , Liz Cook  4 , Elizabeth S Coleman  4 , Caroline Fairhurst  4 , Catherine Hewitt  4 , Stephen W Hutchins  5   6 , Andrew Thompson  2
Affiliations
Randomized Controlled Trial

Unloading shoes for intermittent claudication: a randomised crossover trial

Garry A Tew et al. BMC Cardiovasc Disord. .

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 h every day. The primary outcome was 6-min 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-min 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.

Keywords: Cross-over studies; Foot orthoses; Gait; Peripheral arterial disease.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the NRES Committee for Yorkshire & The Humber - Leeds West (Ref: 15/YH/0107), and prospectively registered (ClinicalTrials.gov: NCT02505503). Written informed consent was obtained from participants prior to enrolment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Unloading shoes (a) and control shoes (b)
Fig. 2
Fig. 2
Flow of participants through the trial
See this image and copyright information in PMC

References

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