ACTRN12621001383853进行中(未招募)未知
A single-centre, double-blinded, randomised placebo-controlled trial to determine the effect of a 12-week home-based program of footplate neuromuscular electrical stimulation on walking capacity in people with peripheral artery disease.
niversity of the Sunshine Coast0 个研究点目标入组 180 人开始时间: 2021年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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).
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