Treatment of Chronic Stroke With AMES + EMG Biofeedback

Stroke Clinical Trial

— AMES  

Official title:

Treatment of Chronic Stroke With AMES + EMG Biofeedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116544
• Other study ID #: CT NS060192
• Status: Completed
• Phase: N/A
• Start date: September 21, 2007
• Est. completion date: February 28, 2011

Study information

• Verified date: October 2019
• Source: AMES Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 28, 2011
• Est. primary completion date: February 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Paresis
• Plegia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Northwestern University	Chicago	Illinois
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
AMES Technology	Emory University, Northwestern University, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Secondary	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.	Within a week of completing all training sessions.
Secondary	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.	Within a week of completing all training sessions.
Secondary	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.	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Secondary	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.	At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.