York Study of Unloading Shoes for Vascular Intermittent Claudication

NCT02505503 | Completed

• 1 other identifier: YOR - A02382
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Claudication; Footwear; Shoes; Walking capacity; Walking distance

Outcome Measures

Primary Outcomes (1)

• Total distance walked during 6-minute walk test

  Following a rest period of at least 20 minutes, participants will complete a 6-minute walk test in which they will be instructed to walk as far as possible within 6 minutes. A straight 30-m course will be used and the distance walked recorded.

  Measured 40 minutes after putting on the intervention or control shoes

Secondary Outcomes (6)

• Pain-free walking distance during usual-pace walking

  Measured 20 minutes after putting on the intervention or control shoes

• Walking speed

  Measured 60 minutes after putting on the intervention or control shoes

• Step length

  Measured 60 minutes after putting on the intervention or control shoes

• Step cadence

  Measured 60 minutes after putting on the intervention or control shoes

• Muscle activation

  Measured 60 minutes after putting on the intervention or control shoes

Other Outcomes (1)

• Adverse events / adverse device effects

  Participants will be followed for the duration of their study involvement, an expected average of 5 weeks.

Study Arms (2)

Unloading shoes

ACTIVE COMPARATOR

The unloading shoe will be a trainer-type shoe with a cosmetically-shaped rocker sole. The sole will have three circular curves whose arc centres are positioned at the anatomical ankle, hip and knee respectively; assuming a vertical lower limb. This 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: Unloading shoes; Device: Unadapted control shoe

Unadapted control shoes

PLACEBO COMPARATOR

The control shoes will be similar in appearance to the unloading shoes, but they will not contain the altered sole.

Device: Unloading shoes; Device: Unadapted control shoe

Interventions

Unloading shoes DEVICE

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.

Unadapted control shoes; Unloading shoes

Unadapted control shoe DEVICE

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.

Unadapted control shoes; Unloading shoes

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥16 years with intermittent claudication due to peripheral arterial disease
• Resting ankle-brachial index ≤0.9 and/or imaging evidence of peripheral arterial disease
• Stable symptoms for at least 3 months (assessed via self-report)
• Pain-free walking distance \<250 m on 6-minute walk test
• Ambulation that is limited primarily by calf claudication on 6-minute walk test
• Able to provide written informed consent
• Able to read and speak English

You may not qualify if:

• Absolute contraindications to exercise testing as defined by the American College of Sports Medicine
• Critical limb ischemia
• Function is uniquely impaired, e.g. vascular amputees
• Co-morbidities that limit walking to a greater extent than intermittent claudication (e.g. severe arthritis)
• Ambulation limited by claudication in regions other than the calf
• Current or previous (within 6 months) use of shoe inserts, knee or ankle braces or customised shoes prescribed by a health professional
• Ankle/foot pathology/pain on either side
• "High-risk" foot (e.g. significant peripheral neuropathy, foot deformity, history of foot ulceration), assessed by a vascular specialist (Registrar or Consultant) or podiatrist

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead
• University of York: collaborator
• York St John University: collaborator
• University of Salford: collaborator

Study Sites (2)

York St John University

York, North Yorkshire, YO31 7EX, United Kingdom

Location

York Teaching Hospital NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

Location

Related Publications (2)

• Jordan AR, Tew GA, Hutchins SW, Shalan A, Cook L, Thompson A. Three-curve rocker-soled shoes and gait adaptations to intermittent claudication pain: A randomised crossover trial. Gait Posture. 2019 Jan;67:31-36. doi: 10.1016/j.gaitpost.2018.09.001. Epub 2018 Sep 22.

  PMID: 30265963 DERIVED

• Tew GA, Shalan A, Jordan AR, Cook L, Coleman ES, Fairhurst C, Hewitt C, Hutchins SW, Thompson A. Unloading shoes for intermittent claudication: a randomised crossover trial. BMC Cardiovasc Disord. 2017 Nov 28;17(1):283. doi: 10.1186/s12872-017-0716-x.

  PMID: 29179693 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Garry Tew, PhD

  University of York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

GB (2)