AMES Treatment of the Proximal Arm in Chronic Stroke (AMES)
|ClinicalTrials.gov Identifier: NCT01934439|
Recruitment Status : Unknown
Verified February 2015 by Paul J. Cordo, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : September 4, 2013
Last Update Posted : February 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Accident||Device: 30 PAAD treatments||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: PAAD (Proximal Arm AMES Device)Treatments
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.
- Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ]
- Ashworth Spasticity Scale [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ]
- Modified Wolf Motor Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ]
- Box and Block Test [ Time Frame: Baseline and change from baseline at 0 and 3 months post completion ]
- Upper extremity strength of the shoulder and elbow joints [ Time Frame: Baseline, after each of 30 treatments, 3 months post completion of all treatments ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934439
|Contact: Linda D Cordo, MSNfirstname.lastname@example.org|
|United States, Oregon|
|Oregon Health and Science University West Campus||Recruiting|
|Beaverton, Oregon, United States, 97006|
|Contact: Linda D Cordo, MSN 503-223-3442 email@example.com|
|Contact: Paul J Cordo, Ph.D 503-418-2520 firstname.lastname@example.org|
|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|