Rocker soles for the treatment of intermittent claudication

ISRCTN	ISRCTN79785265
DOI	https://doi.org/10.1186/ISRCTN79785265
Secondary identifying numbers	Version 1

Submission date: 26/05/2008
Registration date: 04/06/2008
Last edited: 07/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Hutchins
Scientific

Brian Blatchford Building
University of Salford
Frederick Road
Salford
M6 6PU
United Kingdom

Phone	+44 (0)161 295 2320
Email	s.hutchins@salford.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The efficacy of rocker soles in alleviating the symptoms of intermittent claudication: a randomised controlled trial
Study acronym	Rocker trial
Study objectives	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(s)	Not provided at time of registration - submission pending
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2009
Completion date	01/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120 (60 per randomised group)
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	01/07/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Salford

Salford
M6 6PU
United Kingdom

Sponsor information

University of Salford (UK)
University/education

School of Health Care Professions
Frederick Road
Salford
Manchester
M6 6PU
England
United Kingdom

Phone	+44 (0)161 295 2320
Email	s.hutchins@salford.ac.uk
Website	http://www.salford.ac.uk
"ROR"	https://ror.org/01tmqtf75

Funders

Funder type

Other

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan