York Study of Unloading Shoes for Vascular Intermittent Claudication

Summary

Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life.

The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC.

A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes.

Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.

Conditions

• Intermittent Claudication
• Peripheral Arterial Disease

Interventions

DEVICE

Unloading shoes

The unloading shoe will be a trainer-type shoe with a rocker sole incorporated. The sole is designed to influence the line of action of the ground reaction force to pass close to the anatomical joint centres and so reduce the moments needed to be generated for ambulation by the muscles acting across those joints in the lower limb. Additionally it is designed to place the ankle into a relatively plantarflexed position where the ankle plantarflexors use less energy than for instance when placed in dorsiflexion.

DEVICE

Unadapted control shoe

During the control condition assessments, participants wear a pair of appropriately-sized shoes, which are similar in appearance to the unloading shoes, but do not contain the altered sole.

Sponsors & Collaborators

• University of York

  collaborator OTHER

• York St John University

  collaborator OTHER

• University of Salford

  collaborator OTHER

• York Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Garry Tew, PhD · University of York

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2016-08-31

Completion

2016-09-30

Countries

• United Kingdom

Study Locations