Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207240
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2024-01-03
Brief Title:
Functional Electrical Stimulation Therapy After Stroke
Sponsor:
Battelle Memorial Institute
Organization:
Battelle Memorial Institute
Study Overview
Official Title:
Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors
Status:
COMPLETED
Status Verified Date:
2024-01
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 goal of this feasibility study is to test the feasibility of providing task-oriented intention-driven functional electrical stimulation FES using the novel NeuroLife FES Sleeve and NeuroLife electromyography EMG and FES Sleeve devices in chronic stroke survivors The main questions it aims to answer are
Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care
How does therapy using these devices impact the upper limb function in a few chronic stroke survivors
Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks
Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care
How does therapy using these devices impact the upper limb function in a few chronic stroke survivors
Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks
Detailed Description:
Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices wearable sleeves that deliver non-invasive functional electrical stimulation FES paired with user intention Participants in this study will use these devices while practicing functional tasks for about one hour at each session FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone
Sessions will be scheduled three days per week for 8 weeks total Participants will complete clinical assessments at the beginning midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment Each session will last 15-2 hours and participants will be compensated for their time
Sessions will be scheduled three days per week for 8 weeks total Participants will complete clinical assessments at the beginning midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment Each session will last 15-2 hours and participants will be compensated for their time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None