Evaluation of Lower Limb Haemodynamics Using Three (TRI) Neuromuscular Electrical Stimulation Foot Pad Programmes: A Crossover (X) Randomised Controlled Study in Healthy (HE) Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
The goal of this clinical investigation is to evaluate the performance of three neuromuscular electrical stimulation (NMES) foot pad programmes in healthy adults. It will also learn about how well the NMES programmes are tolerated.
The main questions it aims to answer are:
- Do two newly-developed NMES programmes ('P1' and 'PM7') increase lower limb blood flow more than the existing 'Medic' NMES programme during use?
- How do the programmes compare in terms of user discomfort and muscle oxygenation during use?
Researchers will compare the P1 and PM7 programmes with the existing Medic programme to determine whether the new programmes produce greater improvements in lower limb haemodynamics during device use.
Participants will:
- Attend four study visits at a single research site.
- Complete 1 familiarisation visit and 3 testing visits, with 12 hours to 7 days between visits.
- Use all three NMES programmes once in a randomised order.
- Receive 30 minutes of NMES during each testing visit.
- Undergo blood flow and muscle oxygenation measurements during each test.
- Complete questionnaires about discomfort and their experience using the device.
详细描述
The TRI-HEX study is a single-centre, randomised, double-blind, crossover clinical investigation evaluating the haemodynamic performance of three neuromuscular electrical stimulation (NMES) foot pad programs delivered through an investigational version of the Revitive device platform. The study will recruit 24 healthy adult participants in the United Kingdom.
Revitive is a non-invasive NMES device designed to improve blood circulation in the lower limbs during use. The investigational device (14065AT) is derived from the commercially available Revitive Medic Coach device and incorporates firmware modifications that enable delivery of additional predefined stimulation programmes for research purposes. The modification does not alter the device's intended purpose, mode of action, hardware, materials, or electrical output limits.
The study will evaluate three NMES programmes:
Medic - the currently marketed Revitive NMES foot pad programme. Programme 1 (P1) - a newly developed stimulation program designed to minimise muscle adaptation during use.
Personalised Medic v7 (PM7) - a stimulation programme that incorporates a personalised modulation function intended to optimise haemodynamic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or over
- •Ability to communicate in English and provide informed consent
排除标准
- •Lack of capacity to provide informed consent
- •Electronic implanted device (e.g. cardiac pacemaker)
- •Pregnancy or intending to become pregnant during the study period
- •Currently being treated for or have symptoms of an existing deep vein thrombosis (DVT)
- •Diagnosis of vascular disease or disorder
- •Terminal illness
- •Neurological disorders (e.g. epilepsy)
- •Musculoskeletal injury/disorders (e.g. recent injury or surgery)
- •Skin conditions (e.g. eczema or open wounds near plantar surface of the foot)
- •Cardiovascular conditions (e.g. arrhythmia or uncontrolled hypertension)
- •Diabetes mellitus with neuropathy.
研究组 & 干预措施
P1
Participants receive the Programme 1 (P1) delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
干预措施: P1 (Device)
PM7
Participants receive the PM7 programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
干预措施: PM7 (Device)
Medic
Participants receive the Medic programme delivered via the investigational medical device. This arm consists of a single 30-minute neuromuscular electrical stimulation session.
干预措施: Medic (Device)
结局指标
主要结局
未指定
次要结局
- Discomfort during NMES stimulation(During the 30-minute stimulation session)
研究者
Joey Porter
Research Scientist
Actegy Ltd.