Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-01
Brief Title:
Facilitating Neuroplastic Changes of Acute Stroke Survivors
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Facilitating Neuroplastic Changes of Acute Stroke Survivors with Severe Hemiplegia
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-stroke including patients who are paralyzed with no motor output The early acute stroke rehabilitation device will be evaluated in this clinical trial
Detailed Description:
Stroke survivors often experience loss of motor control and impaired function Immediately after stroke there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur Therefore early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability However acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day Especially for those acute patients with no voluntary motor output active motor training might be even less partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes To address this unmet clinical need this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output The early acute stroke rehabilitation device will be evaluated in this clinical trial
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