AMES Treatment of the Proximal Arm in Chronic Stroke
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients|
- Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
- Ashworth Spasticity Scale [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
- Modified Wolf Motor Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
- Box and Block Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]
- Upper extremity strength of the shoulder and elbow joints [ Time Frame: Baseline, after each of 30 treatments, 3 months post completion of all treatments ] [ Designated as safety issue: No ]The PAAD measures the strength at the elbow and shoulder by recording the torque applied by the subject to the device with the elbow and shoulder during maximal efforts.
- Reaching Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ] [ Designated as safety issue: No ]In the Reaching Test, a video system will test each participant's pointing accuracy and smoothness of transportation of the arm to reach specific targets.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment using the PAAD (Proximal Arm AMES Device)
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934439
|Contact: Linda D Cordo, MSNemail@example.com|
|United States, Oregon|
|Oregon Health and Science University West Campus||Recruiting|
|Beaverton, Oregon, United States, 97006|
|Contact: Linda D Cordo, MSN 503-223-3442 firstname.lastname@example.org|
|Contact: Paul J Cordo, Ph.D 503-418-2520 email@example.com|
|Sub-Investigator: Paul J Cordo, Ph.D|
|Principal Investigator:||Barry Oken, MD||Oregon Health and Science University|
|Study Director:||Paul J Cordo, Ph.D||Oregon Health and Science University|