Deep Vein Thrombosis Clinical Trial
Official title:
Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
Verified date | March 2017 |
Source | National University Hospital, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 6, 2017 |
Est. primary completion date | December 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Singapore,
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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2010;(8):CD001922. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of DVT | The primary outcome is a presence of DVT detected on a screening compression duplex ultrasonography | 4 weeks | |
Primary | Ankle range of motion | Measurement of the range of motion of the ankle joint to determine the effect on joint contracture | 4 weeks |
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