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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03068338
• Date of registration: 26/02/2017
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
• Scientific title: Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
• Date of first enrolment: February 16, 2017
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03068338
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Singapore

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Deep Vein Thrombosis

Ankle Joint Contracture

Intervention(s)

Device: Intermittent pneumatic compression

Device: Robotic Sock

Primary Outcome(s)

Ankle range of motion [Time Frame: 4 weeks]

Presence of DVT [Time Frame: 4 weeks]

Secondary ID(s)

RSDVT001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors