Clinic-Based AMES Treatment of Stroke "AMES"

Terminated

Phase 1/2 Results N/A

Trial Description

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.

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.

Trial Stopped: Funding unavailable at this time for this particular study.

Conditions

Interventions

  • AMES device Device
    Intervention Desc: This non-invasive, patented technology has been shown in pre-clinical trials to significantly increase mobility, manipulative skills, and everyday functionality in highly disabled chronic stroke patients
  • The AMES device Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: One

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment of the Lower Extremity.
Secondary Gait Assessment, Stroke Impact Scale, Spasticity (Modified Ashworth) Scale, Biodex Isokinetic Strength Measurements, Strength Test, Joint Position Test, & Passive Motion Test.
Primary Fugl-Meyer Assessment of the Lower Extremity Pre-treatment, Post-treatment No
Secondary Gait Assessment Pre-treatment, Post-treatment No
Secondary Stroke Impact Scale Pre-treatment, Post-treatment No
Secondary Spasticity (Modified Ashworth) Scale Pre-treatment, Post-treatment No
Secondary Biodex Isokinetic Strength Measurements Pre-treatment, Post-treatment No
Secondary Strength Test Prior to each treatment session No
Secondary Joint Position Test Prior to each treatment session No
Secondary Passive Motion Test Prior to each treatment session No

Sponsors