Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

AMES Treatment of the Proximal Arm in Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Oregon Health and Science University
Oregon Community Foundation
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University Identifier:
First received: August 26, 2013
Last updated: February 23, 2015
Last verified: February 2015

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

Condition Intervention Phase
Cerebrovascular Accident
Device: 30 PAAD treatments
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ashworth Spasticity Scale [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
  • Modified Wolf Motor Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Box and Block Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
  • Upper extremity strength of the shoulder and elbow joints [ Time Frame: Baseline, after each of 30 treatments, 3 months post completion of all treatments ] [ Designated as safety issue: No ]
    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.

  • Reaching Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01934439

Contact: Linda D Cordo, MSN 503-223-3442

United States, Oregon
Oregon Health and Science University West Campus Recruiting
Beaverton, Oregon, United States, 97006
Contact: Linda D Cordo, MSN    503-223-3442   
Contact: Paul J Cordo, Ph.D    503-418-2520   
Sub-Investigator: Paul J Cordo, Ph.D         
Sponsors and Collaborators
Oregon Health and Science University
Oregon Community Foundation
Principal Investigator: Barry Oken, MD Oregon Health and Science University
Study Director: Paul J Cordo, Ph.D Oregon Health and Science University
  More Information

Responsible Party: Paul J. Cordo, Sub-Investigator, Oregon Health and Science University Identifier: NCT01934439     History of Changes
Other Study ID Numbers: IRB00009262, OCF9009196
Study First Received: August 26, 2013
Last Updated: February 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Cerebrovascular Accident

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on February 25, 2015