CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
AMES device (test) +2 moredevice
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/NCT00609115
NCT00609115N/ACompleted
CompareCT.gov

Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation

AMES Technology·interventional·Posted Feb 6, 2008·Updated Oct 3, 2022

In Brief

A clinical study evaluating AMES device (test), AMES device (sham), and 1 other intervention for Cerebrovascular Stroke. Completed, enrolled 83 participants across 5 sites.

Detailed Summary

The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrovascular Stroke
CountriesUnited States
CollaboratorsNorthwest Medical Rehabilitation, Spokane, WA, Emory University, University of California, San Francisco, Shirley Ryan AbilityLab, Eisenhower Medical Center, Legacy Health System

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartSep 1, 2007
Primary CompletionFeb 28, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.4 years ago

Interventions

AMES device (test)device

Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.

AMES device (sham)device

Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) in which the limb is moved, but no active assistance is provided by the subject and the vibration is delivered at a very low frequency to the shortening (i.e., rather than lengthening) muscle. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.

AMES device (crossover)device

Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.