Clinic-Based AMES Treatment of Stroke

This study has been terminated.
(Funding unavailable at this time for this particular study.)
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00600184
First received: December 31, 2007
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The AMES device a investigational device which cyclically rotates the ankle while muscle vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. In effect, the device provides assisted movement of a joint and enhanced sensation of that movement. The purpose of this study is to determine whether stroke survivors who remain unable to move normally more than one year after their stroke will be able to walk and move their affected leg significantly better after treatment with a new robotic therapy, the AMES device.


Condition Intervention Phase
Stroke
Cerebrovascular Accident
Device: The AMES device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinic-Based Assisted Movement and Enhanced Sensation Treatment of Stroke

Resource links provided by NLM:


Further study details as provided by AMES Technology:

Primary Outcome Measures:
  • Fugl-Meyer Assessment of the Lower Extremity [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait Assessment [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
  • Spasticity (Modified Ashworth) Scale [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
  • Biodex Isokinetic Strength Measurements [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
  • Strength Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
  • Joint Position Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
  • Passive Motion Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2008
Estimated Study Completion Date: February 2013
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One Device: The AMES device
The AMES device is a investigational device which cyclically rotates the ankle while muscle vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. Each subject will be tested before and after the 10-week treatment period. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.

Detailed Description:

Each year, more that 600,000 U.S. citizens survive a major stroke. Following acute treatment, 30-40% of these survivors sustain permanent motor disabilities. Within weeks of the stroke, surviving patients begin physical therapy to restore motion to affected limbs. Some recover completely, but many do not. There are over 5 million stroke survivors in the U.S. who did not recover completely and many are severely incapacitated for the remainder of their lives.

The hypothesis underlying stroke rehabilitation with AMES is that, in many stroke victims, the damage to the brain disrupts one or more feedback loops that connect the proprioceptive receiving areas of the primary somatosensory cortex to the primary and pre-motor cortex. Without proprioceptive information feeding into the motor output center, the brain cannot "locate" the muscles needed for movement to occur. The hypothesis behind AMES rehabilitation is that synchronous and repetitive activity of the input and output areas of the cortex stimulate the reorganization of brain pathways, thereby closing the feedback loop disrupted by the stroke.

Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, were not brought to a level of maximal recovery. The aim of the study is to obtain a set of data from a total of 16 chronic stroke subjects, all with lower extremity disability, between the ages of 18-75, using the AMES robotic device in a rehabilitation clinic. Each subject will participate in 10 weeks of therapy, 3 days per week, 30 minutes per day. The data collected will be analysed to quantify the extent to which a combination of robot-assisted exercise and muscle vibration induce secondary recovery from stroke in the lower extremity.

  Eligibility

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

Inclusion Criteria:

  • At least 12 months post-stroke
  • Cognitively and behaviorally capable of complying with the regimen
  • Functioning proprioception
  • Less than 50% of normal strength in the affected ankle, but able to stand with ot without assistive devices

Exclusion Criteria:

  • Fractures of treated limb resulting in loss of range of motion
  • Spinal cord injury
  • Deep vein thrombosis
  • Peripheral nerve injury or neuropathy in the affected limb with motor disability
  • Osteoarthritis limiting range of motion
  • Skin condition not tolerant of device
  • Progressive neurodegenerative disorder
  • Uncontrolled seizure disorder
  • Botox treatment within the last 5 months
  • Baclofen pump
  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 ClinicalTrials.gov identifier: NCT00600184

Locations
United States, Oregon
Oregon Health and Science University Center for Health and Healing
Portland, Oregon, United States, 97201
Sponsors and Collaborators
AMES Technology
Oregon Health and Science University
Investigators
Principal Investigator: Paul J. Cordo, PhD AMES Technology Inc./ Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: Paul J. Cordo, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00600184     History of Changes
Other Study ID Numbers: CT002, IRB00004005
Study First Received: December 31, 2007
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by AMES Technology:
Stroke
Rehabilitation
Robotics

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014