AMES Treatment of the Proximal Arm in Chronic Stroke (AMES)

March 27, 2019 updated by: Paul J. Cordo, Oregon Health and Science University

AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients

Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • Oregon Health and Science University West Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ischemic or Hemorrhagic stroke affecting the right arm
  • One year or longer since stroke
  • Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24
  • Right elbow and shoulder spasticity (Ashworth score ≤3)
  • Right shoulder abduction-elbow flexion dyssynergia

Exclusion Criteria:

  • Exercise intolerance
  • Co-morbidities limiting arm movement (e.g. shoulder subluxation)
  • Chronic pain
  • Cognitive dysfunction preventing compliance with instructions
  • Participation in other ongoing research studies
  • Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAAD (Proximal Arm AMES Device)Treatments
The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement.
Device: 30 PAAD treatments
Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment - Upper Extremity
Time Frame: Baseline and change from baseline at 0 and 3 months post completion
Baseline and change from baseline at 0 and 3 months post completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Ashworth Spasticity Scale
Time Frame: Baseline and change from baseline at 0 and 3 months post completion
Baseline and change from baseline at 0 and 3 months post completion
Modified Wolf Motor Test
Time Frame: Baseline and change from baseline at 0 and 3 months post completion
Baseline and change from baseline at 0 and 3 months post completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test
Time Frame: Baseline and change from baseline at 0 and 3 months post completion
Baseline and change from baseline at 0 and 3 months post completion
Upper extremity strength of the shoulder and elbow joints
Time Frame: Baseline, after each of 30 treatments, 3 months post completion of all treatments
The PAAD measures the strength at the elbow and shoulder by recording the torque applied by the subject to the device with the elbow and shoulder during maximal efforts.
Baseline, after each of 30 treatments, 3 months post completion of all treatments
Reaching Test
Time Frame: Baseline and change from baseline at 0 and 3 months post completion
In the Reaching Test, a video system will test each participant's pointing accuracy and smoothness of transportation of the arm to reach specific targets.
Baseline and change from baseline at 0 and 3 months post completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Study Director: Paul J Cordo, Ph.D, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00009262
  • OCF9009196 (Other Identifier: Oregon Community Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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