Treatment of Chronic Stroke With AMES + EMG Biofeedback

NCT01116544 | Completed Results

• 1 other identifier: CT NS060192
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.

Conditions

Stroke; Plegia; Paresis; Cerebrovascular Accident

Keywords

AMES device; Cerebrovascular Accident; Chronic Stroke; Rehabilitation; Upper Extremity; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Box and Blocks Test

  Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.

  Within a week of completing all training sessions.

Secondary Outcomes (5)

• Fugl-Meyer (UL) Assessment

  At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

• Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)

  Within a week of completing all training sessions.

• Stroke Impact Scale (Stroke Recovery)

  Within a week of completing all training sessions.

• Strength Test Flexion

  At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

• Strength Test Extension

  At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.

Study Arms (2)

AMES therapy with EMG biofeedback

EXPERIMENTAL

The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. This study will examine whether AMES therapy combined with EMG biofeedback can restore hand opening to plegic stroke subjects.

Device: AMES Therapy (assisted movement and enhanced sensation)

AMES therapy with Torque biofeedback

EXPERIMENTAL

The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of torque (force) the subject is able to generate in the hand during the movement. This study will examine whether AMES therapy combined with Torque biofeedback can restore hand opening to plegic stroke subjects.

Device: AMES Therapy (assisted movement and enhanced sensation)

Interventions

AMES Therapy (assisted movement and enhanced sensation) DEVICE

Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.

Also known as: Robotic

AMES therapy with EMG biofeedback; AMES therapy with Torque biofeedback

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual upper extremity weakness.
• Chronic stroke, occurring ≥12 months prior to subject enrollment.
• Age 18-80 years old.
• Inability to move any of the fingers of the affected hand more than 5.0 cm into extension.
• Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale.
• Measureable EMG (\>2 x baseline) in the long finger extensor muscle during attempted hand opening or closing.
• Physically and cognitively capable of consenting to and complying with the protocol (based on exam by Study Physician).
• Subject must be physically capable of communicating informed consent or must be accompanied by legally authorized representative to provide informed consent.

You may not qualify if:

• Complete flaccidity of the affected arm.
• Significant upper extremity proprioceptive deficit (\<70% correct detection of the direction of passive finger movement with eyes closed).
• Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or resulting in pain in the arm.
• Spinal cord injury, arthritis, or fractures of affected arm that have resulted in loss of range of motion.
• Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the tested arm.
• Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance.
• Major active psychiatric disorder.
• Cognitively or behaviorally unable to follow instructions including severe apraxia; inability to understand verbal (English) directions, or inability to communicate adequately with study personnel.
• Size of arm incompatible with the AMES device (checked by placing the limb in the device).
• Severe contractures or decreased range of motion or skin condition that would prohibit comfortable positioning or tolerance of the device or the vibrators.
• Any progressive neurodegenerative disorder affecting the upper extremity motor system.
• Uncontrolled seizure disorder.
• Current abuse of alcohol or drugs.
• Terminal illness with anticipated survival of \<12 months.
• Current or planned concurrent participation in another study involving therapy to the impaired arm

Sponsors & Collaborators

• AMES Technology: lead
• Oregon Health and Science University: collaborator
• Emory University: collaborator
• Northwestern University: collaborator

Study Sites (3)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.

  PMID: 24232364 DERIVED

MeSH Terms

Conditions

Stroke; Paralysis; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Paul Cordo
• Organization: Oregon Health & Science University

cordop@ohsu.edu

503 418 2520

Study Officials

• Paul J. Cordo, PhD

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: September 21, 2007
• Primary Completion: February 28, 2011
• Study Completion: February 28, 2011
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (3)