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Treatment of Chronic Stroke With AMES + EMG Biofeedback (AMES)

Primary Purpose

Stroke, Plegia, Paresis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AMES Therapy (assisted movement and enhanced sensation)

About this trial

This is an interventional treatment trial for Stroke focused on measuring AMES device, Cerebrovascular Accident, Chronic Stroke, Rehabilitation, Upper Extremity, Biofeedback

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University School of Medicine
Northwestern University
Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AMES therapy with EMG biofeedback

AMES therapy with Torque biofeedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Box and Blocks Test

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

Secondary Outcome Measures

Fugl-Meyer (UL) Assessment

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.

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

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)

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 Flexion

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.

Strength Test Extension

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.

Full Information

NCT ID

NCT01116544

First Posted

May 3, 2010

Last Updated

October 29, 2019

Sponsor

AMES Technology

Collaborators

Oregon Health and Science University, Emory University, Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01116544

Brief Title

Treatment of Chronic Stroke With AMES + EMG Biofeedback

Acronym

AMES

Official Title

Treatment of Chronic Stroke With AMES + EMG Biofeedback

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 21, 2007 (Actual)

Primary Completion Date

February 28, 2011 (Actual)

Study Completion Date

February 28, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AMES Technology

Collaborators

Oregon Health and Science University, Emory University, Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Plegia, Paresis, Cerebrovascular Accident

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMES therapy with EMG biofeedback

Arm Type

Experimental

Arm Description

Arm Title

AMES therapy with Torque biofeedback

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

AMES Therapy (assisted movement and enhanced sensation)

Other Intervention Name(s)

Robotic

Intervention Description

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.

Primary Outcome Measure Information:

Title

Box and Blocks Test

Description

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

Time Frame

Within a week of completing all training sessions.

Secondary Outcome Measure Information:

Title

Fugl-Meyer (UL) Assessment

Description

Time Frame

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

Title

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

Description

Time Frame

Within a week of completing all training sessions.

Title

Stroke Impact Scale (Stroke Recovery)

Description

Time Frame

Within a week of completing all training sessions.

Title

Strength Test Flexion

Description

Time Frame

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

Title

Strength Test Extension

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul J. Cordo, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

Facility Information:

Facility Name

Emory University School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24232364

Citation

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. Erratum In: J Neurol Phys Ther. 2014 Apr;38(2):147.

Results Reference

derived

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Treatment of Chronic Stroke With AMES + EMG Biofeedback

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