Overview

This trial is active, not recruiting.

Conditions stroke, plegia, paresis, cerebrovascular accident
Treatment ames therapy (assisted movement and enhanced sensation)
Phase phase 1/phase 2
Sponsor AMES Technology
Collaborator Oregon Health and Science University
Start date April 2010
End date December 2013
Trial size 64 participants
Trial identifier NCT01116544, CT NS060192

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 (assisted movement and enhanced sensation) Robotic
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.
(Experimental)
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.
ames therapy (assisted movement and enhanced sensation) Robotic
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 Outcomes

Measure
Box and Blocks Test
time frame: Before starting treatments, After completing all treatments

Secondary Outcomes

Measure
Fugl-Meyer Motor Assessment Upper Extremity
time frame: Before starting treatments, After completing all treatments
Stroke Impact Scale
time frame: Before starting treatments, After completing all treatments
Montreal Cognitive Assessment (MOCA)
time frame: Prior to the start of treatment
Passive Motion Test
time frame: Prior to each treatment session
Strength/Co-contraction Test
time frame: Prior to each treatment session
Finger Range of Motion
time frame: Prior to start of treatment, After completing all treatments.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Treatment of Chronic Stroke With AMES + 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by AMES Technology.