Ignite Creation Date:
2024-05-05 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00609115
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2007-12-27
Brief Title:
Sub-Acute Stroke Rehabilitation With AMES
Sponsor:
AMES Technology
Organization:
AMES Technology
Study Overview
Official Title:
Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation
Status:
COMPLETED
Status Verified Date:
2022-02
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:
AMES
Brief Summary:
The AMES device is designed to produce functional cortical changes by1 assisting the subject as heshe attempts to move the limb assisted movement and 2 enhancing movement sensation by vibrating the muscles during movement enhanced sensation The primary hypothesis is that the combination of assisted movement and enhanced sensation from muscle vibration can increase the amount of motor recovery in individuals disabled by a stroke
Detailed Description:
Approximately 700000 US citizens have a stroke each year with about half ending up with significant motor disabilities There are an estimated 5 million stroke survivors in the US making strokes the leading cause of long-term disability in the US Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery
The AMES device was designed to be able to provide therapy for the hand fingerswrist In this 18 treatment sessions double-blinded control study AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2
The AMES device was designed to be able to provide therapy for the hand fingerswrist In this 18 treatment sessions double-blinded control study AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2
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