Contact information
Type
Scientific
Primary contact
Dr Stephen Hutchins
ORCID ID
Contact details
Brian Blatchford Building
University of Salford
Frederick Road
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2320
s.hutchins@salford.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov 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
Acronym
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.
Hypothesis:
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Intermittent claudication
Intervention
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
Other
Phase
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
01/01/2009
Overall trial end date
01/07/2010
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/01/2009
Recruitment end date
01/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Salford
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
University of Salford (UK)
Sponsor details
School of Health Care Professions
Frederick Road
Salford
Manchester
M6 6PU
United Kingdom
+44 (0)161 295 2320
s.hutchins@salford.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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