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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Modified Ashworth Scale (MAS)
Timeframe: Baseline assessment
Modified Ashworth Scale (MAS)
Timeframe: Post-intervention assessment at 21 days
Modified Ashworth Scale (MAS)
Timeframe: Post-intervention assessment at 3 month follow up visit
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
Timeframe: Baseline assessment
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
Timeframe: Post-intervention assessment at 21 days
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
Timeframe: Post-intervention assessment at 3 month follow up visit
Ankle Range of Motion (ROM)
Timeframe: Baseline assessment
Ankle Range of Motion (ROM)
Timeframe: Post-intervention assessment at 21 days
Ankle Range of Motion (ROM)
Timeframe: Post-intervention assessment at 3 month follow up visit
Medical Research Council (MRC) Scale for muscle strength
Timeframe: Baseline assessment
Medical Research Council (MRC) Scale for muscle strength
Timeframe: Post-intervention assessment at 21 days
Medical Research Council (MRC) Scale for muscle strength
Timeframe: Post-intervention assessment at 3 months follow up visit
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Timeframe: Baseline assessment
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Timeframe: Post-intervention assessment at 21 days
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Timeframe: Post-intervention assessment at 3 months follow-up
Functional Ambulation Categories (FAC)
Timeframe: Baseline assessment
Functional Ambulation Categories (FAC)
Timeframe: Post-intervention assessment at 21 days
Functional Ambulation Categories (FAC)
Timeframe: Post-intervention assessment at 3 months follow-up
10 meters walk test (10MWT)
Timeframe: Baseline assessment
10 meters walk test (10MWT)
Timeframe: Post-intervention assessment at 21 days
10 meters walk test (10MWT)
Timeframe: Post-intervention assessment 3 months follow-up
functional Magnetic Resonance Imaging (fMRI)
Timeframe: Post-intervention assessment at 6 weeks follow-up
Compression Ultrasound Sonography (U/S) for the lower limbs
Timeframe: Baseline measurement
Compression Ultrasound Sonography (U/S) for the lower limbs
Timeframe: Post-intervention assessment at 21 days.