Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Stephen Hutchins


Contact details

Brian Blatchford Building
University of Salford
Frederick Road
M6 6PU
United Kingdom
+44 (0)161 295 2320

Additional identifiers

EudraCT number number

Protocol/serial number

Version 1

Study information

Scientific title

The efficacy of rocker soles in alleviating the symptoms of intermittent claudication: a randomised controlled trial


Rocker trial

Study hypothesis

Intermittent claudication is a vascular disease affecting the lower limbs. Sudden pain is normally experienced in the calf muscles which forces subjects with the condition to eventually stop walking. After a short period of rest, they are able to start walking again until the pain again becomes intolerable.

That a specifically-designed rocker sole profile may help alleviate the painful symptoms of intermittent claudication in older subjects. The intervention will be through the addition of a specifically-designed rocker sole profile added to the base of stock therapeutic shoes. This profile has been designed and tested using 12 healthy subjects during gait laboratory testing and it has been demonstrated that it statistically significantly reduces the sagittal plane power absorbed and generated at the ankle during walking. It is hoped that this reduction will translate into improved symptoms for patients with intermittent claudication by reducing the work done by the muscles acting across the ankle joint during stance phase of gait when walking with the rocker sole profile added to their shoes.

Ethics approval

Not provided at time of registration – submission pending

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Intermittent claudication


Volunteer claudicants will be recruited onto the study via attendance at the Lifestyle Management Clinic in the Vascular Department at Wirral University Teaching Hospitals NHS Trust, Wirral, England, UK.

The intervention group will wear a shoe adapted with a rocker profile for a two-week period. The control group will be given an un-adapted pair of shoes to wear, which will be exactly the same style as the intervention group in order to eliminate footwear design factors between the two groups. The intervention group will wear the same shoes as the control group during the two-week trial period but with the rocker sole profile added also. The control group will therefore not receive any rocker sole type intervention but will wear a pair of shoes supplied for the trial which they are free to keep at the end of the two weeks.

Intervention type



Not Applicable

Drug names

Primary outcome measures

The following hospital-based walking trials will be held immediately before and after the two-week home trials:
1. Pain-free walking distance (PFWD) to the sudden onset of calf claudication pain
2. Overall intensity of calf claudication pain whilst claudicating
3. Maximum walking distance (MWD) before having to stop due to the intensity of the calf pain
4. Walking speed, step length and cadence

Secondary outcome measures

Quality of life (QOL) indicators using the intermittent claudication questionnaire (ICQ) before and after the two-week trial. It is anticipated that a future larger trial will be needed to provide statistically significant differences to QOL indicators, but this trial will give an indication and will inform the total number of recruits required in a subsequent trial study.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Both males and females, over 18 years of age. There are no upper age limits
2. Those who have been diagnosed with stabilised intermittent claudication in one or both calf muscles
3. Ankle brachial pressure index of 0.8 or less
4. Those who have a maximum walking distance of between 10-300 m before having to stop walking due to their calf pain which is not being improved by other conservative interventions

Participant type


Age group




Target number of participants

120 (60 per randomised group)

Participant exclusion criteria

Subjects with a history of lower limb joint replacement, cerebrovascular accident (CVA), or any orthopaedic or neurological impairment which adversely affects their gait or negates the fitting of stock therapeutic shoes

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Brian Blatchford Building
M6 6PU
United Kingdom

Sponsor information


University of Salford (UK)

Sponsor details

School of Health Care Professions
Frederick Road
M6 6PU
United Kingdom
+44 (0)161 295 2320

Sponsor type




Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes