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Clinic-Based AMES Treatment of Stroke

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ClinicalTrials.gov Identifier: NCT00847704
Recruitment Status : Terminated (Funding not available.)
First Posted : February 19, 2009
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
AMES Technology
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University

Study Description
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Brief Summary:
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Device: Assisted movement and enhanced sensation Phase 1 Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
Study Start Date : April 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Test treatment group
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.


Outcome Measures
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Primary Outcome Measures :
  1. Fugl-Meyer Assessment of the Lower Extremity [ Time Frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up ]
    Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.


Secondary Outcome Measures :
  1. Timed 10-Meter Walk [ Time Frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up ]
    Gait Assessment - Time

  2. Stroke Impact Scale [ Time Frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up ]

    The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:

    Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.

    Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.


  3. Spasticity (Modified Ashworth) Scale [ Time Frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up ]
    Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.

  4. Strength Test [ Time Frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) ]
    Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).

  5. Active Motion Test [ Time Frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) ]
    Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847704


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

Publications:

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Responsible Party: Paul J. Cordo, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00847704    
Obsolete Identifiers: NCT00600184
Other Study ID Numbers: IRB 4005
First Posted: February 19, 2009    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: November 2016
Keywords provided by Paul J. Cordo, Oregon Health and Science University:
Stroke
Rehabilitation
Robotics
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases