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ISRCTN
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ISRCTN79785265
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ClinicalTrials.gov identifier
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Public title
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Rocker soles for the treatment of intermittent claudication
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Scientific title
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The efficacy of rocker soles in alleviating the symptoms of intermittent claudication: a randomised controlled trial
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Acronym
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Rocker trial
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Serial number at source
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Version 1
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Study hypothesis
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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 had 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.
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Ethics approval
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To be submitted as of 26/05/2008.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Intermittent claudication
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/01/2009
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Anticipated end date
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01/07/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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120 (60 per randomised group)
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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.
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Sources of funding
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Sources of funding not yet defined as of 26/05/2008.
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Trial website
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Publications
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Contact name
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Dr
Stephen
Hutchins
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Address
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Brian Blatchford Building
University of Salford
Frederick Road
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City/town
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Salford
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Zip/Postcode
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M6 6PU
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Country
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United Kingdom
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Tel
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+44 (0)161 295 2320
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Fax
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+44 (0)161 295 2342
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Email
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s.hutchins@salford.ac.uk
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Sponsor
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University of Salford (UK)
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Address
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School of Health Care Professions
Frederick Road
Salford
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City/town
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Manchester
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Zip/Postcode
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M6 6PU
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Country
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United Kingdom
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Tel
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+44 (0)161 295 2320
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Fax
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+44 (0)161 295 2432
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Email
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s.hutchins@salford.ac.uk
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Sponsor website:
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http://www.salford.ac.uk
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Date applied
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26/05/2008
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Last edited
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26/06/2008
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Date ISRCTN assigned
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04/06/2008
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