AMES Treatment of the Proximal Arm in Chronic Stroke

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients

Conditions
-----------------
Stroke, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Device: 30 PAAD treatments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic or Hemorrhagic stroke affecting the right arm One year or longer since stroke Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24 Right elbow and shoulder spasticity (Ashworth score ≤3) Right shoulder abduction-elbow flexion dyssynergia Exclusion Criteria: Exercise intolerance Co-morbidities limiting arm movement (e.g. shoulder subluxation) Chronic pain Cognitive dysfunction preventing compliance with instructions Participation in other ongoing research studies Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAAD (Proximal Arm AMES Device)Treatments<br>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. | Device: 30 PAAD treatments<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Upper Extremity |  | Baseline and change from baseline at 0 and 3 months post completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ashworth Spasticity Scale |  | Baseline and change from baseline at 0 and 3 months post completion | 
| Modified Wolf Motor Test |  | Baseline and change from baseline at 0 and 3 months post completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotics, Stroke, Rehabilitation, Dyssynergia, AMES, Cerebrovascular Accident