Rocker soles for the treatment of intermittent claudicatio

Not Applicable

Completed

Conditions: Intermittent claudication
Musculoskeletal Diseases
Other peripheral vascular diseases

Registration Number: ISRCTN79785265

Lead Sponsor: niversity of Salford (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following hospital-based walking trials will be held immediately before and after the two-week home trials:<br>1. Pain-free walking distance (PFWD) to the sudden onset of calf claudication pain <br>2. Overall intensity of calf claudication pain whilst claudicating <br>3. Maximum walking distance (MWD) before having to stop due to the intensity of the calf pain <br>4. Walking speed, step length and cadence

Secondary Outcome Measures

Name	Time	Method
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.