Clinic-Based AMES Treatment of Stroke

This study has been terminated.
Sponsor:
Collaborator:
AMES Technology
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00847704
First received: February 18, 2009
Last updated: December 17, 2009
Last verified: February 2009
  Purpose

The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.


Condition Intervention Phase
Stroke
Cerebrovascular Accident
Device: Assisted movement and enhanced sensation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fugl-Meyer Assessment of the Lower Extremity [ Time Frame: 0 months, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait Assessment [ Time Frame: 0 months, 3 month, and 6 months ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: 0 months, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Spasticity (Modified Ashworth) Scale [ Time Frame: 0 months, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Biodex Isokinetic Strength Measurements [ Time Frame: 0 months, 3 months, and 6 months ] [ 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 ]

Estimated Enrollment: 20
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One
Device: Assisted movement and enhanced sensation
Device: Assisted movement and enhanced sensation
Each subject will be tested before, after the 10 week treatment period and then 3 months later. 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.
Device: Assisted movement and enhanced sensation
Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments.

  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 or 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 limb affected 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: NCT00847704

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
AMES Technology
Investigators
Principal Investigator: Paul J. Cordo, PhD AMES Technology Inc./Oregon Health and Science University
  More Information

Additional Information:
Publications:
Responsible Party: Paul J. Cordo/Principal Investigator, Oregon Health and Science University/ AMES Technology
ClinicalTrials.gov Identifier: NCT00847704     History of Changes
Other Study ID Numbers: IRB 4005
Study First Received: February 18, 2009
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
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 August 26, 2014