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临床试验/NCT03068338
NCT03068338已完成不适用

Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Presence of DVT

研究概览

简要总结

The research team's aim is to investigate the effects of the team's soft robotic socks in providing assisted ankle dorsiflexion-plantarflexion and promoting venous blood flow in stroke patients. Specifically, the investigators intend to 1) observe the development of joint contracture in terms of the range of motion of the ankle joint given the use of the device 2) monitor the presence of blood clots in the deep veins using compression Duplex ultrasonography given the use of the sock device.

The investigators hypothesize that a soft robotics approach can provide compliant actuation to simulate natural ankle dorsiflexion and plantarflexion, which will consequently promote blood circulation in the lower leg of stroke patients who have not previously developed ankle joint contracture. This will prevent the occurrence of DVT and movement in the ankle joint will alleviate stiffness. This robotic sock intervention is to prevent the development of ankle joint contracture so established ankle contractures will be excluded from this study.

详细描述

The investigator's proposed robotic sock solution is capable of providing programmable robot-assisted ankle exercises to chronic bedridden patients, thereby improving venous blood flow, and preventing DVT and ankle joint contractures. Compared to conventional mechanical prophylaxis such as the intermittent pneumatic compression devices, the robotic sock is likely to cost almost five times less, and potentially generate patient/hospital savings of up to $2750 per patient. The use of the robotic sock will also raise therapist productivity through automating the therapy exercises of the bedridden patients, and this could potentially save the therapists at least 6 workhours per day. The use of the robotic sock in hospitals, nursing homes and patients' own homes will likely reduce healthcare costs and prevent side effects, as compared to conventional DVT prophylaxis approaches. In addition, it will add new values and benefits to public healthcare by eliminating additional treatment costs arising from DVT-related complications, increasing therapists' productivity (especially given growing manpower constraints and greying population), optimizing therapy time, and ultimately saving precious lives.

Among those diagnosed with DVT, 10-30% dies within 1 month of diagnosis (Beckman et al., 2010), and worldwide 600,000-800,000 people die annually (worldthrombosisday.org). This research seeks to lower DVT risk through a safe non-drug-based approach by continuously moving the ankle joint into dorsiflexion-plantarflexion using soft robotics. Current alternatives to prevent DVT include pharmacological prophylaxis such as anticoagulant drugs, mechanical prophylaxis such as intermittent pneumatic compression devices and compression stockings, and the basic therapist-assisted exercises to prevent ankle joint contractures. Pharmacological prophylaxis can improve venous blood flow and prevent DVT, but run the risk of detrimental side effects like excessive bleeding. Mechanical prophylaxis can provide passive or automated stimulation to the calf tissue, but have been reported to deliver limited efficacy in improving venous blood flow and preventing DVT. Considering the data from the United States and United Kingdom, the annual spending incurred due to direct and indirect costs resulting from DVT is approximated to be US$2-10 billion and this ranges from US$7,594-US$16,644 per patient (Spyropoulos and Lin, 2007). Therefore, by implementing the robotic sock device, the investigators hope to enable clinicians to focus on treating patients towards stroke recovery without worrying about other complications.

Joint contractures, usually defined as limited passive range of joint motion are common in people with neurological conditions such as stroke or spinal cord injury. The risk factors for joint contractures are not well understood; however, immobility seems to be the most important factors. Joint contractures, especially in the ankle joints, may impede the ability to walk and cause loss of balance, high risk of falls and restricted participation in social activities. The frequency of ankle contractures in hospitalized patients varies with prevalence rates ranging from 24 % to 44 %.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ischemic or haemorrhagic stroke patients with severe lower limb weakness (MRC scale <3) in flexors and extensors of knee and ankle

排除标准

  • Medically unstable patients
  • Queried pulmonary embolism (PE) / deep vein thrombosis (DVT) cases
  • Limited range of motion in ankle and foot including equinus or club foot deformity
  • Lower limb dermatitis, ulcer or open wound
  • Severe spasticity of ankle (modified Ashworth scale >2)
  • Pregnancy

研究组 & 干预措施

Conventional therapy

Active Comparator

Intermittent pneumatic compression devices are used for prevention of DVT.

干预措施: Intermittent pneumatic compression (Device)

Robotic Sock

Experimental

Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.

干预措施: Robotic Sock (Device)

结局指标

主要结局

Presence of DVT

时间窗: 4 weeks

The primary outcome is a presence of DVT detected on a screening compression duplex ultrasonography

Ankle range of motion

时间窗: 4 weeks

Measurement of the range of motion of the ankle joint to determine the effect on joint contracture

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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