AMES Treatment of the Proximal Arm in Chronic Stroke

Oregon Health & Science University (OHSU)

Status and phase: Withdrawn; Phase 1

Conditions: Cerebrovascular Accident; Stroke

Treatments: Device: 30 PAAD treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT01934439

OCF9009196 (Other Identifier)

IRB00009262

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PAAD (Proximal Arm AMES Device)Treatments

Experimental group

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.

Treatment:

Device: 30 PAAD treatments