AMES Treatment of the Proximal Arm in Chronic Stroke "AMES"

Recruiting

Phase 1 Results N/A

Trial Description

Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.

Detailed Description

This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.

Conditions

Interventions

  • 30 PAAD treatments Device
    Intervention Desc: Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.
    ARM 1: Kind: Experimental
    Label: Treatment using the PAAD (Proximal Arm AMES Device)
    Description: The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement.
    ARM 2: Kind: Experimental
    Label: PAAD (Proximal Arm AMES Device)Treatments
    Description: The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment - Upper Extremity Baseline and change from baseline at 0 and 3 months post completion No
Secondary Ashworth Spasticity Scale Baseline and change from baseline at 0 and 3 months post completion No
Secondary Modified Wolf Motor Test Baseline and change from baseline at 0 and 3 months post completion No

Sponsors