Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655636
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-25
Brief Title:
Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assisting Stroke Survivors With Engineering Technology ASSET Design Project D3 Exoskeletal Networks for Forearm Supination
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety feasibility and efficacy of an exoskeletal network of passive multi-joint springs for forearm supination Also known as the forearm ExoNET the device is a passive robotic device that will properly assist forearm supination in the post-stroke adult population
Detailed Description:
The ExoNET a passive robotic solution that provides a soft biomimetic and elastic alternative to robotics that embodies intelligence within the mechanical design Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization Here it is possible to have a simple reconfigurable system that can not only assist performance but can also make training easier faster and more complete This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology
The primary objective of this study is to evaluate the safety feasibility and efficacy of using the forearm ExoNET Specifically investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion To accomplish this we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET To achieve these goals we will use a wearable surface electromyography EMG and inertial measurement unit IMU using Delsys wearable sensors on the forearm muscles
Investigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test ARAT measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support Secondarily investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke Lastly it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe feasible and tolerated by patients in a given treatment session
The primary objective of this study is to evaluate the safety feasibility and efficacy of using the forearm ExoNET Specifically investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion To accomplish this we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET To achieve these goals we will use a wearable surface electromyography EMG and inertial measurement unit IMU using Delsys wearable sensors on the forearm muscles
Investigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test ARAT measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support Secondarily investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke Lastly it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe feasible and tolerated by patients in a given treatment session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None