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 not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS 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(s)

Not provided at time of registration –- submission pending

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study 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

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

Overall study end date

01/07/2010

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

England, United Kingdom

Study 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
England
United Kingdom
+44 (0)161 295 2320
s.hutchins@salford.ac.uk

Sponsor type

University/education

Website

http://www.salford.ac.uk

ROR

https://ror.org/01tmqtf75

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes