Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05560867
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2022-07-25
Brief Title:
Neural Mechanisms of Motor Recovery With Technology Assisted Training
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Technical issues with study robotics preventing completion of the research intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is a leading cause of disability that often impairs arm function and activities of daily living The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages 6 months post-stroke This study will determine which patients are best able to benefit from this therapy approach and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training The results of this study will help to improve rehabilitation and quality of life for disabled Americans
Detailed Description:
Study Description This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy fNIRS Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training
Objectives 1 to investigate brain network activity changes that occur during technology-assisted-training and 2 to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training
Endpoints The study will evaluate increases in cortical connectivity between bilateral primary motor areas angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training
Study Population Patients of either gender with chronic at least 6 months or more hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties
Objectives 1 to investigate brain network activity changes that occur during technology-assisted-training and 2 to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training
Endpoints The study will evaluate increases in cortical connectivity between bilateral primary motor areas angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training
Study Population Patients of either gender with chronic at least 6 months or more hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties
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?:
True
Is an FDA AA801 Violation?:
None