Sub-Acute Stroke Rehabilitation With AMES

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.

Conditions

• Cerebrovascular Stroke

Interventions

DEVICE

AMES device (test)

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.

DEVICE

AMES device (sham)

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.

DEVICE

AMES device (crossover)

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.

Sponsors & Collaborators

• Northwest Medical Rehabilitation, Spokane, WA

  collaborator UNKNOWN

• Emory University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• Eisenhower Medical Center

  collaborator OTHER

• Legacy Health System

  collaborator OTHER

• AMES Technology

  lead INDUSTRY

Principal Investigators

• Paul J. Cordo, PhD · AMES Technology Inc./ Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-01

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• United States

Study Locations