AMES Treatment of the Proximal Arm in Chronic Stroke

NCT ID: NCT01934439

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-03-31

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.

Conditions

Stroke; Cerebrovascular Accident

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

30 PAAD treatments

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Cordo

Sub-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry Oken, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Paul J Cordo, Ph.D

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

Oregon Health and Science University West Campus

Beaverton, Oregon, United States

Countries

United States

References

Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.

Reference Type: BACKGROUND

PMID: 18645190 (View on PubMed)

Other Identifiers

OCF9009196

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00009262

Identifier Type: -

Identifier Source: org_study_id