Promoting Neuroplastic Changes of Patients With TBI

University of Maryland Baltimore (UMB)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Device: Motor relearning training with wearable ankle robot; Device: Active movement training with limited wearable ankle robot; Device: Passive movement with limited wearable ankle robot; Device: Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot; Device: Passive stretching with wearable ankle robot; Device: Gamed-based active movement training with wearable ankle robot

Study type: Interventional

Funder types: Other

Identifiers

NCT06465290

HP-00110703

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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Full 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.

Enrollment: 100 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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100 participants in 2 patient groups

Study group - Intensive ankle/hand robot rehab

Experimental group

Description:

Ankle/Hand 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 with wearable ankle robot

Device: Passive stretching with wearable ankle robot

Device: Motor relearning training with wearable ankle robot

Control group - Mild ankle/hand 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/Wrist torque and motion measurement with limited wearable ankle/wrist robot

Device: Active movement training with limited wearable ankle robot

Device: Passive movement with limited wearable ankle robot