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

NCT ID: NCT03068338

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2017-12-06

Brief 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 %.

Conditions

Deep Vein Thrombosis; Ankle Joint Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Conventional therapy

Intermittent pneumatic compression devices are used for prevention of DVT.

Group Type: ACTIVE_COMPARATOR

Intermittent pneumatic compression

Intervention Type: DEVICE

Conventional device used by hospitals

Robotic Sock

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

Group Type: EXPERIMENTAL

Robotic Sock

Intervention Type: DEVICE

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

Interventions

Robotic Sock

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

Intervention Type: DEVICE

Intermittent pneumatic compression

Conventional device used by hospitals

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

References

Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern. Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501. doi: 10.1016/j.amepre.2009.12.017.

Reference Type: BACKGROUND

PMID: 20331949 (View on PubMed)

Roderick P, Ferris G, Wilson K, Halls H, Jackson D, Collins R, Baigent C. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technol Assess. 2005 Dec;9(49):iii-iv, ix-x, 1-78. doi: 10.3310/hta9490.

Reference Type: BACKGROUND

PMID: 16336844 (View on PubMed)

Mazzone C, Chiodo GF, Sandercock P, Miccio M, Salvi R. Physical methods for preventing deep vein thrombosis in stroke. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001922. doi: 10.1002/14651858.CD001922.pub2.

Reference Type: BACKGROUND

PMID: 15495020 (View on PubMed)

Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. J Manag Care Pharm. 2007 Jul-Aug;13(6):475-86. doi: 10.18553/jmcp.2007.13.6.475.

Reference Type: BACKGROUND

PMID: 17672809 (View on PubMed)

Other Identifiers

RSDVT001

Identifier Type: -

Identifier Source: org_study_id