Clinical trial NCT01116544: Treatment of Chronic Stroke With AMES + EMG Biofeedback
Official title: Treatment of Chronic Stroke With AMES + EMG Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Plegia
Paresis
Cerebrovascular Accident
Keywords: AMES device
Cerebrovascular Accident
Chronic Stroke
Rehabilitation
Upper Extremity
Biofeedback
Lead sponsor: AMES Technology
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
name: Emory University
name: Northwestern University
First posted: 2010-05-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Box and Blocks Test
timeFrame: Within a week of completing all training sessions.
Secondary outcomes:
measure: Fugl-Meyer (UL) Assessment
timeFrame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
measure: Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
timeFrame: Within a week of completing all training sessions.
measure: Stroke Impact Scale (Stroke Recovery)
timeFrame: Within a week of completing all training sessions.
measure: Strength Test Flexion
timeFrame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
measure: Strength Test Extension
timeFrame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paul J. Cordo, PhD
role: STUDY_DIRECTOR
References:
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.