Development of a FES Device for Hand Use During Arm Activities Following Stroke
Development of a FES Device for Hand Use During Arm Activities Following Stroke
The goal of the study is to develop an individualized, synergy resistant, portable
 electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for
 Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during
 lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic
 and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use
 utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording
 and stimulation electrode. To test the device feasibility, a small clinical trial will be
 conducted. Information related to the clinical trial will be provided below.
Individuals with moderate to severe stroke will be recruited for both lab-based testing and
 home-based practice:

 1. Pre-training clinical evaluation (lab-based). In this session, a research physical
 therapist will evaluate the participant's arm function and impairment level using
 standardized clinical assessments to ensure eligibility for participating in this study.
 Once confirmed, a set of standardized clinical assessments will be conducted by the
 research physical therapist as the baseline assessments of the participant's hand/arm
 function. This visit is expected to last approximately 3 hours.

 2. Pre-training device setup (lab-based). The participant will be randomly assigned to one
 of the recruited physical therapists (PTs) or senior student physical therapists (SPTs)
 who has been recruited and consented to participate in this study. The assigned PT will
 determine 1) the electrode positions for recording the participant's muscle activities
 during the performance of different arm/hand functions, and 2) the stimulation electrode
 positions and stimulation intensities for achieving the best hand opening with the
 forearm at the individual's mid-range of available supination/pronation. Then, the
 corresponding electrode positions will be marked, and the forearm/hand with these
 markers will be scanned. This visit is expected to last approximately 3 hours. The
 scanned results will be used offline to develop a forearm-hand orthosis (FHO) that fits
 the participant's forearm and hand. During this visit, the investigators will measure
 the time for the PT/SPT to set up 1) recording electrodes, 2) detecting rules, 3)
 stimulation electrodes and configuration, and 4) the time for scanning.

 3. Pre-training device-use learning sessions (2 visits, lab-based). After the FHO is ready,
 the participant will be called to participate in the 1st and 2nd lab-based training
 sessions for the use of ReIn-hand device. During these 2 visits, the assigned PT/SPT
 (1st test) or the research PT (2nd test) will train the participant to use the FHO and
 the ReIn-Hand software on a mobile device, until the participant demonstrates the
 ability in using the device independently twice in a row. During these 2 visits, the
 investigators will measure the time for the participant to 1) learn the use of the
 ReIn-Hand device (from the start of the session to the time that the participant is able
 to demonstrate ability to independently use the device twice in a row), 2) attach the
 FHO, 3) use the software for 1 trial (including connecting all the cables following the
 instructions, start the software and finish 1 trial), and 4) clean up. At the end of the
 1st (for PTs) or the 2nd (for individuals with stroke) learning sessions, a 5min user
 survey will be conducted to report the level of ease-of-use of the ReIn-Hand device.
 During the 2nd learning session, the participant will also be re-tested on part of the
 clinical assessments, however, this time with the assistance of the ReIn-Hand device.
 Each of these 2 visits is expected to last about 3 hours.

 4. Pre-training 2nd baseline clinical measures (lab-based). Within one week prior to
 starting the Home-based practice, a research PT will conduct the 2nd baseline clinical
 measures, which will repeat the 1st baseline clinical measures with an additional
 quantitative measure of maximal hand opening area and closing force (QMHOC). For QMHOC,
 pressure sensors (Pressure Profile Systems, Inc., Los Angeles, CA 90045) in conjunction
 with portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI) will
 be used. The whole QMHOC will take about 10 minutes, and the whole 2nd baseline clinical
 measure session will take about 2 hours.

 5. Pre-training EEG measures (lab-based). Within one week prior to starting the Home-based
 practice and within one week following completion of the 12-week Home-based practice,
 the participant will take part in an EEG experiment. During this session, a 9x9 mm
 marker will be placed on the tip of each finger, with another on the back of the hand as
 reference, which will allow for the measure of the position and angle of the
 fingers/hand by 2 portable Moire Phase Tracking cameras (180 Hz; Metria Innovation Inc.
 Milwaukee, WI). In addition, surface EEG electrodes will be mounted on a stretchable
 fabric cap based on the 10/20 system. A Polaris Krios handheld scanner and reflective
 markers (NDI, Ontario, Canada) will be used to record the EEG electrode positions
 compared to the coordinate system defined by the nasion, inion, and pre-auricular
 notches. Eye movement detection electrodes will also be placed on the supra- and
 infra-orbital margins for detection of vertical eye movement. EMG will be recorded from
 the extensor carpi radialis, flexor carpi radialis, and deltoid of the arm.

 Once prepared, the participant will be seated in an experimental chair with: 1)
 adjustable straps across the shoulders and waist to maintain proper posture, 2) paretic
 forearm attached to an orthosis that is linked to the ACT-3D, a robot that will provide
 required arm support, 3) hand around a cylinder with a custom pressure sensor mat
 (Pressure Profile System Inc., CA). The participant will be instructed to perform 1 of 2
 movements: 1) hand opening while resting on a haptic table, or 2) hand opening while
 lifting against 50% of their maximum shoulder abduction force. The investigator will
 measure scalp recordings and EMG recordings using a 160-channel EEG/EMG system using
 active electrodes (Biosemi, Inc., Active II, Amsterdam, The Netherlands), hand opening
 area or finger flexion force.

 6. Home-based practice. After above 5 lab-based visits, participants will take the
 ReIn-Hand device, including the FHO, the mobile device with ReIn-Hand software, and the
 electronic stimulator (300 PV, Empi, Minnesota, USA, a FDA approved clinical device)
 back home. At home, participants will perform 20 trials of pre-set tasks, like reaching
 and grasping, per session (1 hour), 1 session per day, 7 days per week for 12 weeks.
 During these 12 weeks, the participant will visit the lab once per week to make
 necessary device changes, and perform part of the clinical assessments and QMHOC measure
 without the ReIn-hand.

 7. Post-training tests (lab-based). The sessions #4 mentioned above will be repeated at one
 week and 3-month after the 12-week home-based practice. The session #5 will be repeated
 at one week after the 12-week home-based practice. All the post-training tests will be
 preformed without ReIn-hand device.
Inclusion Criteria:

 -  Age between 21-80

 -  Paresis confined to one side, with substantial motor impairment of the upper limb and
 some residual voluntary movement (UE FMA in the range of 10-40/66, CMSA_H stage of the
 hand section <=4)

 -  Normal Cognitive ability (MOCA score >=24)

 -  Capacity to provide informed consent

 -  Ability to elevate their limb against gravity up to at least 75 degrees of shoulder
 flexion and then to generate some active elbow extension

 -  Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance
 of the ReIn-Hand device with the help of a physical therapist

 -  Discharged from all forms of physical rehabilitation

 -  Intact skin on the hemiparetic arm

 Exclusion Criteria:

 -  Motor or sensory impairment in the non-affected limb

 -  Any brainstem and/or cerebellar lesion

 -  Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled
 hypertension, inflammatory joint disease)

 -  History of neurologic disorder other than stroke (Parkinson's Disease, Amyotrophic
 Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy)

 -  Any acute or chronic painful condition in the upper extremities or spine, indicated by
 a score ≥5 on a 10-point visual analog scale

 -  Using cardiac pacemaker

 -  Seizure

 -  Severe upper extremity sensory impairment indicated by absent sharp-blunt
 discrimination on the tactile sensation subscale of the Revised Nottingham Sensory
 Assessment( the score >=1 on anterior and posterior forearm)

 -  Chemo denervation: botulinum toxin injection to any portion of the paretic UE within
 the last 6 months, or phenol/alcohol injections <12 months before participation

 -  Unable to passively attain 90 degrees of shoulder flexion and abduction, measured
 using a goniometer based on adapted methods

 -  Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal
 joints (MCP) and interphalangeal joints (IP)

 -  Pregnant or planning to become pregnant

 -  Upper extremity musculoskeletal impairment limiting function prior to stroke.