The Foot-PAD trial: Effect of a footplate muscle stimulation program on walking capacity in people with Peripheral Artery Disease.

Not Applicable

Active, not recruiting

• Conditions: peripheral artery disease; intermittent claudication; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12621001383853
• Lead Sponsor: niversity of the Sunshine Coast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-14
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Clinical diagnosis of PAD with intermittent claudication by a vascular surgeon, confirmed with 1) positive Edinburgh Claudication Questionnaire; and 2) resting ABI less than 0.9; OR positive walking claudication test (fall in ankle pressure greater than 30mmHg (or 20%), following treadmill walking test).
2.18 years of age or older.
3.Able to understand and communicate in English sufficient to complete the informed consent.
; 1.Clinical diagnosis of PAD with intermittent claudication by a vascular surgeon, confirmed with 1) positive Edinburgh Claudication Questionnaire; and 2) resting ABI less than 0.9; OR positive walking claudication test (fall in ankle pressure greater than 30mmHg (or 20%), following treadmill walking test).
2.18 years of age or older.
3.Able to understand and communicate in English sufficient to complete the informed consent.

Exclusion Criteria

1.Walking distance limited by symptoms other than claudication / leg discomfort during initial treadmill screening walking test.
2.Critical limb ischaemia including rest-pain, arterial ulcers (tissue loss) or gangrene.
3.Severe disease requiring surgical or endovascular intervention.
4.Previous lower limb or foot amputation.
5.Plantar wounds, including broken or bleeding skin, or ulcers.
6.Any implanted electronic, cardiac or defibrillator device.
7.Being treated for lower limb deep vein thrombosis (DVT) or potential presence of DVT based on presentation.
8.Pregnant or intending to become pregnant during trial period.
9.Has participated in a supervised exercise program within the previous three-month period.
10.Has used any form of lower limb neuromuscular electrical stimulation therapy within the previous three-month period.
11.Has previously used at any time a Revitive footplate neuromuscular stimulation device.
12.Unwilling or unable to engage with the technology required for the intervention, inc. the need for WiFi internet access.
13.Terminal illness or other medical condition that may affect the ability to complete the trial, or deemed unfit to undertake the trial procedures by the trial medical practitioner (e.g. where walking tests may be contraindicated because of existing or unstable medical condition that may be made worse or exacerbated by participation).
; 1.Walking distance limited by symptoms other than claudication / leg discomfort during initial treadmill screening walking test.
2.Critical limb ischaemia including rest-pain, arterial ulcers (tissue loss) or gangrene.
3.Severe disease requiring surgical or endovascular intervention.
4.Previous lower limb or foot amputation.
5.Plantar wounds, including broken or bleeding skin, or ulcers.
6.Any implanted electronic, cardiac or defibrillator device.
7.Being treated for lower limb deep vein thrombosis (DVT) or potential presence of DVT based on presentation.
8.Pregnant or intending to become pregnant during trial period.
9.Has participated in a supervised exercise program within the previous three-month period.
10.Has used any form of lower limb neuromuscular electrical stimulation therapy within the previous three-month period.
11.Has previously used at any time a Revitive footplate neuromuscular stimulation device.
12.Unwilling or unable to engage with the technology required for the intervention, inc. the need for WiFi internet access.
13.Terminal illness or other medical condition that may affect the ability to complete the trial, or deemed unfit to undertake the trial procedures by the trial medical practitioner (e.g. where walking tests may be contraindicated because of existing or unstable medical condition that may be made worse or exacerbated by participation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-minute walk test (6MWT). Change in maximum walking distance (MWD) during the 6MWT. [ Week 0 (baseline), week 6, week 12 (primary), and week 18. ];Six-minute walk test (6MWT). Change in maximum walking distance (MWD) during the 6MWT. [ Week 0 (baseline), week 6, week 12 (primary), and week 18. ]