Viewing Study NCT01116544



Ignite Creation Date: 2024-05-05 @ 10:27 PM
Last Modification Date: 2024-10-26 @ 10:19 AM
Study NCT ID: NCT01116544
Status: COMPLETED
Last Update Posted: 2019-11-18
First Post: 2010-05-03

Brief Title: Treatment of Chronic Stroke With AMES EMG Biofeedback
Sponsor: AMES Technology
Organization: AMES Technology

Study Overview

Official Title: Treatment of Chronic Stroke With AMES EMG Biofeedback
Status: COMPLETED
Status Verified Date: 2019-10
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 purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device the AMES device and EMG biofeedback
Detailed Description: Over the last 20 years the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology However the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is AMES which stands for Assisted Movement with Enhanced Sensation Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients

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