Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465290
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-24
Brief Title:
Promoting Neuroplastic Changes of Patients with TBI
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Promoting Neuroplastic Changes of Patients with TBI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None