Treatment of Chronic Stroke With AMES + EMG Biofeedback - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stroke Plegia Paresis Cerebrovascular Accident	Device: AMES Therapy (assisted movement and enhanced sensation)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Chronic Stroke With AMES + EMG Biofeedback

Resource links provided by NLM:

MedlinePlus related topics: Paralysis

U.S. FDA Resources

Further study details as provided by AMES Technology:

Primary Outcome Measures:

Box and Blocks Test [ Time Frame: Before starting treatments, After completing all treatments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fugl-Meyer Motor Assessment Upper Extremity [ Time Frame: Before starting treatments, After completing all treatments ] [ Designated as safety issue: No ]
Stroke Impact Scale [ Time Frame: Before starting treatments, After completing all treatments ] [ Designated as safety issue: No ]
Montreal Cognitive Assessment (MOCA) [ Time Frame: Prior to the start of treatment ] [ Designated as safety issue: No ]
Passive Motion Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
Measures joint impedance
Strength/Co-contraction Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
Finger Range of Motion [ Time Frame: Prior to start of treatment, After completing all treatments. ] [ Designated as safety issue: No ]
Measures the amount of movement in the finger showing the greatest amount of movement in the affected hand.

Estimated Enrollment:	64
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AMES therapy with EMG biofeedback 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) 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. Other Name: Robotic
Experimental: AMES therapy with Torque biofeedback 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) 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. Other Name: Robotic

Arms

Assigned Interventions

Experimental: AMES therapy with EMG biofeedback

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)

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.

Other Name: Robotic

Experimental: AMES therapy with Torque biofeedback

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)

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.

Other Name: Robotic

Detailed Description:

Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Planned initiation of or cessation of any kind of clinical therapy to the impaired limb just prior to or during the AMES treatment period.
NIH Stroke Scale, following scores: Sensory Item score of >1; Neglect involving the affected limb score >1.
Intent to receive Botox injections (5 months prior to or during enrollment), initiation of antispasmodic medication, or use of any other robotic (e.g., MANUS, Locomat) or electrical or vibratory stimulation device (e.g., Bioness) while participating in the AMES trial.
Cognitively or behaviorally unable to follow instructions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116544

Locations

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

AMES Technology

Oregon Health and Science University

Emory University

Northwestern University

Investigators

Study Director:

Paul J. Cordo, PhD

Oregon Health and Science University

More Information

No publications provided

Responsible Party:	AMES Technology
ClinicalTrials.gov Identifier:	NCT01116544 History of Changes
Other Study ID Numbers:	CT NS060192
Study First Received:	May 3, 2010
Last Updated:	May 17, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by AMES Technology:

AMES device
Cerebrovascular Accident
Chronic Stroke

Rehabilitation
Upper Extremity
Biofeedback

Additional relevant MeSH terms:

Paresis
Cerebral Infarction
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013