None listed
Conditions
Brief summary
Peripheral artery disease (PAD) is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. This randomised placebo-controlled trial will test the effect of a novel treatment where patients with peripheral artery disease (PAD) will undertake daily periods of neuromuscular electrical stimulation (NMES) using the Revitive® Medic Coach footplate device. This is a class IIa medical device that is commercially available and approved by the Therapeutic Goods Administration (TGA) for use in Australia. Patients use the device by sitting comfortably and placing their bare feet on the rubber foot pads of the device, which deliver the stimulation to the muscles of the feet and legs. If successful, this simple treatment strategy will reduce symptoms (pain, claudication) and improve exercise tolerance (walking capacity) and quality of life, enabling patients to be more physically active.
Interventions
Footplate-NMES (intervention condition). 12-week home-based program using a footplate-NMES device (Revitive® Medic Coach). Participants will experience a range of sensations from light tingling and feelings of pins and needles, to noticeable muscle twitches and contractions in the muscles of the feet and legs. The active device is used 2x30 min periods each day to deliver stimulation sufficient to induce contraction of the leg (calf) muscles.
The Revitive® Medic Coach is a disc-shaped footplat
Footplate-NMES (intervention condition). 12-week home-based program using a footplate-NMES device (Revitive® Medic Coach). Participants will experience a range of sensations from light tingling and feelings of pins and needles, to noticeable muscle twitches and contractions in the muscles of the feet and legs. The active device is used 2x30 min periods each day to deliver stimulation sufficient to induce contraction of the leg (calf) muscles. The Revitive® Medic Coach is a disc-shaped footplate NMES device that provides pre-programmed electrical stimulation to the plantar aspect of the feet to activate the muscles of the feet and calf. The device is designed to be used whilst in a seated position, with the device placed on the floor. The intensity of electrical stimulus can be varied from 0 to 99. Participants will initially complete a 45 min familiarisation session with an unblinded member of the study team (participant support assistant). When first using the NMES device at the familiarisation visit, baseline sensory and motor thresholds will be established by systematically increasing the stimulation intensity in increments of one unit whilst the participant provides verbal sensory feedback. The minimal intensity, at which the participant is able to clearly feel electrical stimulation, will be recorded as the sensory threshold; and that producing visible muscle twitches will be the motor threshold. The stimulation intensity will be adjusted to produce visible but non-painful contraction of the lower limb musculature at twice the individual motor threshold or as much as the participant can tolerate as comfortable, whichever is greater (i.e. the therapy target threshold). Participants will be encouraged increase the intensity of the NMES intervention as tolerated throughout the intervention period. Compliance with intervention device use will be assessed with daily diary and automated device data logging via a smart-phone App.
Sponsors
University of the Sunshine Coast
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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).
Outcome results
None listed