Promoting Neuroplastic Changes of Patients With TBI
Purpose
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.
Condition
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Between 30 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized clinical trial with the study group and control group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Study group - Intensive ankle/hand robot rehab |
Ankle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance |
|
|
Active Comparator Control group - Mild ankle/hand robot rehab |
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 |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
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.