CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
AMES Therapy (assisted movement and enhanced sensation)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01116544
NCT01116544N/ACompleted
CompareCT.gov

Treatment of Chronic Stroke With AMES + EMG Biofeedback

AMES Technology·interventional·Posted May 5, 2010·Updated Nov 18, 2019

In Brief

A clinical study evaluating AMES Therapy (assisted movement and enhanced sensation) for Stroke and 3 related conditions. Completed, enrolled 46 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Plegia, Paresis, Cerebrovascular Accident
CountriesUnited States
CollaboratorsOregon Health and Science University, Emory University, Northwestern University

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2010
Enrollment StartSep 21, 2007
Primary CompletionFeb 28, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.2 years ago

Interventions

AMES Therapy (assisted movement and enhanced sensation)device

Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.