An interventional study of Motor relearning training with wearable ankle robot and Passive stretching with wearable ankle robot in Traumatic Brain Injury, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ankle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
Device: Motor relearning training with wearable ankle robot · Device: Passive stretching with wearable ankle robot · Device: Gamed-based active movement training with wearable ankle robot
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
Device: Passive movement with limited wearable ankle robot · Device: Active movement training with limited wearable ankle robot · Device: Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot
Ankle motor control relearning training under real-time feedback
Passive stretching under intelligent robotic control
Active movement training through movement games with robotic assistance
Passive movement in the joint middle range of motion
Active movement training without robotic assistance
Ankle/Wrist torque and motion measurement with no real-time feedback
Fugl-Meyer Lower Extremity (FMLE)
The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
Active range of motion (AROM)
AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Passive Range of Motion (PROM)
Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Strength of the ankle flexor-extensor muscle
Strength of the ankle flexor-extensor muscle will be measured in Newtons
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
10-meter Walk Test
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Started Jul 2026 (actual). Primary completion is estimated for Aug 2029, 37 months after the start.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 37 months is close to that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
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University of Maryland, Baltimore →