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Effects of shoes in individuals with intermittent claudication

An understanding of footwear and orthotic modifications on gait biomechanics in patients with intermittent claudication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63526638
Enrollment
80
Registered
2014-07-17
Start date
2014-06-15
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease (PAD) Circulatory System Peripheral vascular disease, unspecified

Interventions

Subjects will perform trials in a custom standard shoe, four rocker sole shoes (3 curve rocker, 2 curve rocker, 1 curve rocker, MBT shoe) and a standard ankle foot orthosis.  Participants with PAD wi

Sponsors

University of Salford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participants admitted to the study will range between the ages of 50 and 75. 2. Participants must have a formal diagnosis of intermittent claudication of at least 3 months confirmed by a consultant vascular surgeon. This diagnosis will be derived using colour-flow duplex scan, medical history and examination, and absence or reduction in foot pulses, an ankle brachial pressure index (ABPI) of less than 0.8. 3. Participants must be able to walk a minimum of 100 m or perform 2 minutes of continuous walking unaided. 4. Healthy participants must be aged 50 or over.

Exclusion criteria

Exclusion criteria: 1. Active or a prior history of foot ulcers 2. Significant foot deformities necessitating use of foot orthoses 3. Self-reported complete neuropathy in their feet (a reported lack of diabetes will be verified through a foot sensation test) 4. Surgery in the previous 6 months 5. Pain in their lower limbs or back with a cause unrelated to PAD/IC 6. Painful knee, ankle or hip osteoarthritis 7. Total reliance on walking aids 8. Prior lower limb joint replacement 9. Morbidly obese (BMI>35). Marker placement relies on identification of joint centres and bony landmarks and these must be easily palpated by hand. 10. Healthy participants must not have any of the following: significant pain in the legs when walking, prior injury to the legs or spine, diabetes, foot deformities, prior joint replacement or major orthopaedic surgery.

Design outcomes

Primary

MeasureTime frame
1. External ankle moment 2. EMG muscle activation

Secondary

MeasureTime frame
1. External knee flexion moment 2. Eternal hip flexion moment

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026