This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.
18-89 years of age
Unilateral arm weakness due to stroke (6 months or more since onset)
Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
Previous stroke(s) affecting motor function on the opposite side.
Persistent and severe shoulder subluxation, pain or dislocation
Shoulder passive range of motion < 45 degrees in flexion and abduction
Fixed upper limb contractures on the impaired arm and hand
Parallel
motor learning based therapy
BehavioralMotor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning.
MyoPro
BehavioralThe MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the EMG signal, which triggers activation of a motor within the device. The motor assists the user to complete the desired movement (e.g. opening of the hand).Subjects experience real-time biofeedback through their ability to sense and see movement of the target joint(s) and via their interface with the software on a computer that provides visual feedback of the EMG level of the contracting muscle
Home Exercise Program
BehavioralEvery subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete.
Fugl Meyer for Upper Limb (FM) change
Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points) where higher scores represent better arm function.
Modified Ashworth Scale (MAS)
MAS will be used to assess muscle tone. Using a 5-point scale, resistance to passive movement about a joint with is scored. MAS has been widely used to quantify muscle tone following stroke. MAS of the shoulder internal rotators, elbow flexors/extensors, forearm pronators/supinators, wrist flexors/extensors and finger flexors/extensors will be scored.
Upper limb kinematics
The investigators will use a 3-D optic motion analysis (Vicon) system to assess participants' movement performance during supported forward reach and a forward reach to grasping task. Kinematic variables to be assessed will include joint range of motion used to perform the task and end-point trajectory.
Dynamometry
Muscle force production of the elbow flexors/extensors and wrist flexors/extensors will be assessed using standardized hand-held dynamometry.
Arm Motor Ability Test
AMAT tests the time and quality of performance of 13 different complex tasks of activities of daily living (ADL). Rating is based on the quality of movement, ability to complete the task and time elapsed.
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