Treatment of Chronic Stroke With AMES + EMG Biofeedback

Not Applicable

Completed

Conditions: Cerebrovascular Accident
Plegia
Stroke
Paresis

Interventions: Device: AMES Therapy (assisted movement and enhanced sensation)

Registration Number: NCT01116544

Lead Sponsor: AMES Technology

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMES therapy with EMG biofeedback	AMES Therapy (assisted movement and enhanced sensation)	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.
AMES therapy with Torque biofeedback	AMES Therapy (assisted movement and enhanced sensation)	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.

Primary Outcome Measures

Name	Time	Method
Box and Blocks Test	Within a week of completing all training sessions.	Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer (UL) Assessment	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.	Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.
Strength Test Flexion	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.	Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)	Within a week of completing all training sessions.	Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions \[scored from 1 (least impact) to 5 (most impact)\]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed: \[(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range\] X 100. The minimum transformed score is 0 and the maximum is 100.
Stroke Impact Scale (Stroke Recovery)	Within a week of completing all training sessions.	A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.
Strength Test Extension	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.	Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.

Trial Locations

Locations (3): Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States