NCT06404268

Facilitating Neuroplastic Changes of Acute Stroke Survivors

Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Detailed description

Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Motor relearning training	Ankle motor control relearning training under real-time feedback
DEVICE	Passive stretching	Passive stretching under intelligent robotic control
DEVICE	Gamed-based active movement training	Active movement training through movement games with robotic assistance
DEVICE	Passive movement	Passive movement in the joint middle range of motion
DEVICE	Active movement training	Active movement training without robotic assistance
DEVICE	Ankle torque and motion measurement	Ankle torque and motion measurement with no real-time feedback

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2024-05-08
• Last updated: 2025-07-09

Locations

2 sites across 1 country: United States