Clinic-Based AMES Treatment of Stroke

Terminated

Phase 1/2 Results

Trial 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.

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
  • Assisted movement and enhanced sensation Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: One
    Description: Device: Assisted movement and enhanced sensation

Trial Design

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

Patient Involvement

Each subject in the assisted movement and enhanced sensation group 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.

Each subject in the assisted movement and enhanced sensation group will have 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.

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.

Fugl-Meyer Assessment of the Lower Extremity, Gait Assessment, Stroke Impact Scale, Spasticity (Modified Ashworth) Scale, and Biodex Isokinetic Strength Measurements will be done at baseline, 3 and 6 months. Strength Test, Joint Position Test, and Passive Motion Test will be done prior to each 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.
Secondary Gait Assessment 0 months, 3 month, and 6 months No
Secondary Stroke Impact Scale 0 months, 3 months, and 6 months No
Secondary Spasticity (Modified Ashworth) Scale 0 months, 3 months, and 6 months No
Secondary Biodex Isokinetic Strength Measurements 0 months, 3 months, and 6 months 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

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