NCT06465290

Promoting Neuroplastic Changes of Patients With TBI

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Detailed description

Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.

Conditions

• Traumatic Brain Injury

Interventions

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

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-08-31
• Completion: 2030-08-31
• First posted: 2024-06-18
• Last updated: 2026-02-24