Rocker soles for the treatment of intermittent claudication

• Register: ISRCTN
• Last refreshed on: 3 April 2017
• Main ID: ISRCTN79785265
• Date of registration: 04/06/2008
• Prospective Registration: Yes
• Primary sponsor: University of Salford (UK)
• Public title: Rocker soles for the treatment of intermittent claudication
• Scientific title: The efficacy of rocker soles in alleviating the symptoms of intermittent claudication: a randomised controlled trial
• Date of first enrolment: 01/01/2009
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN79785265
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Stephen Hutchins

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Intermittent claudication
Musculoskeletal Diseases
Other peripheral vascular diseases

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

Version 1

Source(s) of Monetary Support

Not provided at time of registration