Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05854485
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-04-18
Brief Title:
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremityUE combining the interventions- Functional Electrical Stimulation FES and Robotic rehabilitation in individuals with chronic stroke The main question it aims to answer is if the Hybrid multi-muscle FESRobot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone
Detailed Description:
Individuals with chronic stroke 6months after stroke will be recruited All participants will complete clinical and kinematic assessments at 2 time pointsbaseline and after 6 weeks training Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks
Study participants will be randomly assigned to receive either of the following upper extremity training- 1 Hybrid multi-muscle FESRobot training group or 2Robot only training group
The following clinical assessments to measure the motor impairments and functional recovery will be performed Fugl-Meyer Upper Extremity Modified Ashworth Scale and Wolf Motor Function Test
Kinematic assessments will be conducted using the REACH robotic device and the KinereachtrakStar system The following kinematic parameters will be collected Smoothness Range of Motion and Speed
Study participants will be randomly assigned to receive either of the following upper extremity training- 1 Hybrid multi-muscle FESRobot training group or 2Robot only training group
The following clinical assessments to measure the motor impairments and functional recovery will be performed Fugl-Meyer Upper Extremity Modified Ashworth Scale and Wolf Motor Function Test
Kinematic assessments will be conducted using the REACH robotic device and the KinereachtrakStar system The following kinematic parameters will be collected Smoothness Range of Motion and Speed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None