Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
Condition: Deep Vein Thrombosis; Ankle Joint Contracture
MeSH terms: Contracture; Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 %.
    

Intervention name(s): Robotic Sock; Intermittent pneumatic compression
Intervention type(s): Device; Device
Intervention description(s): Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.; Conventional device used by hospitals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility