Facilitating Neuroplastic Changes of Acute Stroke Survivors

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Stroke

Treatments: Device: Active movement training; Device: Passive stretching; Device: Motor relearning training; Device: Passive movement; Device: Ankle torque and motion measurement; Device: Gamed-based active movement training

Study type: Interventional

Funder types: Other

Identifiers

NCT06404268

HP-00110205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
• Hemiplegia or hemiparesis
• 0≤Manual Muscle Testing (MMT)<=2
• Age 30-85
• Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Exclusion criteria

• Medically not stable
• Associated acute medical illness that interferes with ability to training and exercise
• No impairment or very mild ankle impairment of ankle
• Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
• Cognitive impairment or aphasia with inability to follow instructions
• Severe pain in legs
• Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
• Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Study group - Wearable ankle robot rehab

Experimental group

Description:

Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance

Treatment:

Device: Gamed-based active movement training

Device: Passive stretching

Device: Motor relearning training

Control group - Limited wearable ankle robot rehab

Active Comparator group

Description:

The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance

Treatment:

Device: Ankle torque and motion measurement

Device: Passive movement

Device: Active movement training