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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.
Age
30 - 85 years
Sex
ALL
Healthy Volunteers
No
Start Date
May 1, 2026
Primary Completion Date
August 31, 2029
Completion Date
August 31, 2030
Last Updated
February 24, 2026
100
ESTIMATED participants
Motor relearning training with wearable ankle robot
DEVICE
Passive stretching with wearable ankle robot
DEVICE
Gamed-based active movement training with wearable ankle robot
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
DEVICE
Lead Sponsor
University of Maryland, Baltimore
Collaborators
NCT04521881
NCT07455136
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06725108