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Clinical Trial

Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients

NCT: NCT05491109 · COMPLETED

NCT IDNCT05491109
StatusCOMPLETED
Start Date2022-09-01
Completion2023-10-31
SponsorNational University Hospital, Singapore (OTHER)
First posted
Last updated

Brief Summary

Stroke is closely associated with high mortality among patients in hospitals and immobility leading development of deep vein thrombosis (DVT) leading to pulmonary embolism (PE) and Venous thromboembolism (VTE) and/or ankle joint contracture, which impairs mobility resulting in bedridden. Worldwide, the incidences of DVTs is 0.75-2.69 per 1000 individuals and 2-7 per 1000 for individuals aged \> 70 years and accounts for 600,000-800,000 deaths yearly. Pharmacological treatment for DVTs include anti-coagulants to prevent blood clot development and VTE but may cause haemorrhagic stroke leading to death. Non-invasive treatment such as intermittent pneumatic compression (IPC) and anti-embolism stockings may prevent DVT but not ankle joint contractures, which affects 50% of all stroke patients. Joint contractures exacerbate pedal edema and fluid retention, hamper proper joint movement and decreases ADLs and quality of life. Regular physiotherapy is vital for preventing ankle joint contracture and DVT but is labour intensive hence posing an increased workload on physiotherapists resulting in decreased physiotherapy duration. This study will investigate the use of an automated robot-assisted ankle exercise solution (Venous Assistance and Contracture Management System, VACOM) to mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk. The investigators hypothesize that the Venous Assistance and Contracture Management (VACOM) system can prevent ankle contracture, improve ankle range of motion (ROM) and flexibility while reducing the risk of DVT incidence among stroke patients more than using IPC alone. Additionally, through early ankle mobilization, rehabilitation can be optimized to achieve better neurological recovery.

Frequently Asked Questions

What is Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients?

Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients is a clinical trial registered under NCT05491109. Current status: COMPLETED.

What is the status of NCT05491109?

The current status of NCT05491109 (Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients) is: COMPLETED.

When did Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients start?

Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients started on 2022-09-01.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.