Improved Disabilities of the Arm, Shoulder and Hand scores after myoelectric arm orthosis use at home in chronic stroke: A retrospective study.

BACKGROUND: Most stroke survivors have persistent upper limb impairments after completing standard clinical care. The resulting impairments can adversely affect their quality of life and ability to complete self-care tasks and remain employed, leading to increased healthcare and societal costs. A myoelectric arm orthosis can be used effectively to support the affected weak arm and increase an individual's use of that arm. OBJECTIVE: The study objective was to retrospectively evaluate the outcomes and clinical benefits provided by the MyoPro® orthosis in individuals 65 years and older with upper limb impairment secondary to a stroke. METHODS: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was administered to individuals who have chronic stroke both before and after receiving their myoelectric orthosis. A Generalized Estimating Equation model was analyzed. RESULTS: After using the MyoPro, 19 individuals with chronic stroke had a mean improvement (decrease) in DASH score of 18.07, 95% CI = (-25.41, -10.72), adjusted for 8 covariates. This large change in DASH score was statistically significant and clinically meaningful as participants self-reported an improvement with engagement in functional tasks. CONCLUSIONS: Use of the MyoPro increases independence in functional tasks as reported by the validated DASH outcome measure for older participants with chronic stroke.

Myoelectric Arm Orthosis Assists Functional Activities: A 3-Month Home Use Outcome Report.

Objective: The objective was to compare task performance in individuals with upper limb impairments with and without a myoelectric arm orthosis. Design: Three-month observational study. Participants met at 4 time points after receiving their myoelectric orthosis (2-Weeks, Month-1, Month-2, Month-3) to complete 4 standardized common daily tasks. Setting: Nationwide sessions completed remotely over videoconference calls at home. There were no specific clinic affiliations. Participants: Adults with upper limb impairment due to stroke who were in the process of being fit with a myoelectric arm orthosis as a first-time user. Interventions: The orthosis was a custom-fabricated myoelectric arm orthosis called the MyoPro®. Main Outcome Measures: Functional tasks were completed at each session with and without the MyoPro. Participants were evaluated on their success and the time required to complete each functional task. Longitudinal mixed and longitudinal mixed logistic regression models were analyzed. Results: Eighteen individuals with chronic arm weakness due to stroke were included in the analysis. Statistically significant and clinically meaningful improvements were observed on the functional tasks in the participants' homes. By 3 months, participants successfully used the MyoPro to accomplish the tasks, reduced the amount of time spent to complete the tasks, and had a higher probability of success as compared with at 2 weeks. With the MyoPro, participants showed significant improvement in overall task completion and completed the tasks in a significantly decreased time as compared with without the MyoPro. Conclusions: The MyoPro provides a stabilizing support to the weak arm of individuals after stroke and enables individuals to use their impaired arm to complete functional tasks independently in the home environment.

Enabling Technology for Remote Prosthetic Alignment Tuning.

INTRODUCTION: This research has resulted in a system of sensors and software for effectively adjusting prosthetic alignment with digital numeric control. We called this suite of technologies the Prosthesis Smart Alignment Tool (ProSAT) system. MATERIALS AND METHODS: The ProSAT system has three components: a prosthesis-embedded sensor, an alignment tool, and an Internet-connected alignment expert system application that utilizes machine learning to analyze prosthetic alignment. All components communicate via Bluetooth. Together, they provide for numerically controlled prosthesis alignment adjustment. The ProSAT components help diagnose and guide the correction of very subtle, difficult-to-see imbalances in dynamic gait. The sensor has been cross-validated against kinetic measurement in a gait laboratory, and bench testing was performed to validate the performance of the tool while adjusting a prosthetic socket based on machine learning analyses from the software application. RESULTS: The three-dimensional alignment of the prosthetic socket was measured pre- and postadjustment from two fiducial points marked on the anterior surface of the prosthetic socket. A coordinate measuring machine was used to derive an alignment angular offset from vertical for both conditions: pre- and postalignment conditions. Of interest is the difference in the angles between conditions. The ProSAT tool is only controlling the relative change made to the alignment, not an absolute position or orientation.Target alignments were calculated by the machine learning algorithm in the ProSAT software, based on input of kinetic data samples representing the precondition and where a real prosthetic misalignment condition was known a priori. Detected misalignments were converted by the software to a corrective adjustment in the prosthesis alignment being tested. We demonstrated that a user could successfully and quickly achieve target postalignment change within an average of 0.1°. CONCLUSIONS: The accuracy of a prototype ProSAT system has been validated for controlled alignment changes by a prosthetist. Refinement of the ergonomic form and technical function of the hardware and clinical usability of the mobile software application are currently being completed with benchtop experiments in advance of further human subject testing of alignment efficiency, accuracy, and user experience.

Effect of exoskeletal joint constraint and passive resistance on metabolic energy expenditure: Implications for walking in paraplegia.

An important consideration in the design of a practical system to restore walking in individuals with spinal cord injury is to minimize metabolic energy demand on the user. In this study, the effects of exoskeletal constraints on metabolic energy expenditure were evaluated in able-bodied volunteers to gain insight into the demands of walking with a hybrid neuroprosthesis after paralysis. The exoskeleton had a hydraulic mechanism to reciprocally couple hip flexion and extension, unlocked hydraulic stance controlled knee mechanisms, and ankles fixed at neutral by ankle-foot orthoses. These mechanisms added passive resistance to the hip (15 Nm) and knee (6 Nm) joints while the exoskeleton constrained joint motion to the sagittal plane. The average oxygen consumption when walking with the exoskeleton was 22.5 ± 3.4 ml O2/min/kg as compared to 11.7 ± 2.0 ml O2/min/kg when walking without the exoskeleton at a comparable speed. The heart rate and physiological cost index with the exoskeleton were at least 30% and 4.3 times higher, respectively, than walking without it. The maximum average speed achieved with the exoskeleton was 1.2 ± 0.2 m/s, at a cadence of 104 ± 11 steps/min, and step length of 70 ± 7 cm. Average peak hip joint angles (25 ± 7°) were within normal range, while average peak knee joint angles (40 ± 8°) were less than normal. Both hip and knee angular velocities were reduced with the exoskeleton as compared to normal. While the walking speed achieved with the exoskeleton could be sufficient for community ambulation, metabolic energy expenditure was significantly increased and unsustainable for such activities. This suggests that passive resistance, constraining leg motion to the sagittal plane, reciprocally coupling the hip joints, and weight of exoskeleton place considerable limitations on the utility of the device and need to be minimized in future designs of practical hybrid neuroprostheses for walking after paraplegia.

A muscle-driven approach to restore stepping with an exoskeleton for individuals with paraplegia.

BACKGROUND: Functional neuromuscular stimulation, lower limb orthosis, powered lower limb exoskeleton, and hybrid neuroprosthesis (HNP) technologies can restore stepping in individuals with paraplegia due to spinal cord injury (SCI). However, a self-contained muscle-driven controllable exoskeleton approach based on an implanted neural stimulator to restore walking has not been previously demonstrated, which could potentially result in system use outside the laboratory and viable for long term use or clinical testing. In this work, we designed and evaluated an untethered muscle-driven controllable exoskeleton to restore stepping in three individuals with paralysis from SCI. METHODS: The self-contained HNP combined neural stimulation to activate the paralyzed muscles and generate joint torques for limb movements with a controllable lower limb exoskeleton to stabilize and support the user. An onboard controller processed exoskeleton sensor signals, determined appropriate exoskeletal constraints and stimulation commands for a finite state machine (FSM), and transmitted data over Bluetooth to an off-board computer for real-time monitoring and data recording. The FSM coordinated stimulation and exoskeletal constraints to enable functions, selected with a wireless finger switch user interface, for standing up, standing, stepping, or sitting down. In the stepping function, the FSM used a sensor-based gait event detector to determine transitions between gait phases of double stance, early swing, late swing, and weight acceptance. RESULTS: The HNP restored stepping in three individuals with motor complete paralysis due to SCI. The controller appropriately coordinated stimulation and exoskeletal constraints using the sensor-based FSM for subjects with different stimulation systems. The average range of motion at hip and knee joints during walking were 8.5°-20.8° and 14.0°-43.6°, respectively. Walking speeds varied from 0.03 to 0.06 m/s, and cadences from 10 to 20 steps/min. CONCLUSIONS: A self-contained muscle-driven exoskeleton was a feasible intervention to restore stepping in individuals with paraplegia due to SCI. The untethered hybrid system was capable of adjusting to different individuals' needs to appropriately coordinate exoskeletal constraints with muscle activation using a sensor-driven FSM for stepping. Further improvements for out-of-the-laboratory use should include implantation of plantar flexor muscles to improve walking speed and power assist as needed at the hips and knees to maintain walking as muscles fatigue.

Improving stand-to-sit maneuver for individuals with spinal cord injury.

BACKGROUND: Users of neuroprostheses employing electrical stimulation (ES) generally complete the stand-to-sit (STS) maneuver with high knee angular velocities, increased upper limb support forces, and high peak impact forces at initial contact with the chair. Controlling the knee during STS descent is challenging in individuals with spinal cord injury (SCI) due to the decreasing joint moment available with increased knee angle in response to ES. METHODS: The goal of this study was to investigate the effects of incorporating either (1) a coupling mechanism that coordinates hip and knee flexion or (2) a mechanism that damps knee motion to keep the knee angular velocity constant during the STS transition. The coupling and damping were achieved by hydraulic orthotic mechanisms. Two subjects with SCI were enrolled and each served as their own controls when characterizing the performance of each mechanism during STS as compared to stimulation alone. Outcome measures such as hip-knee angle, knee angular velocity, upper limb support force, and impact force were analyzed to determine the effectiveness of the two mechanisms in providing controlled STS. RESULTS: The coordination between the hip and knee joints improved with each orthotic mechanism. The damping and hip-knee coupling mechanisms caused the hip and knee joint ratios of 1:1.1 and 1:0.99, respectively, which approached the 1:1 coordination ratio observed in nondisabled individuals during STS maneuver. The knee damping mechanism provided lower (p < 0.001) and a more constant knee angular velocity than the hip-knee coupling mechanism over the knee range of motion. Both the coupling and damping mechanisms were similarly effective at reducing upper limb support forces by 70 % (p < 0.001) and impact force by half (p ≤ 0.001) as compared to sitting down with stimulation alone. CONCLUSIONS: Orthoses imposing simple kinematic constraints, such as 1:1 hip-knee coupling or knee damping, can normalize upper limb support forces, peak knee angular velocity, and peak impact force during the STS maneuvers.

A stimulation-driven exoskeleton for walking after paraplegia.

An untethered version of a stimulation-driven exoskeleton was evaluated for its ability to restore walking after paralysis from spinal cord injury. The hybrid neuroprosthesis (HNP) combined a passive variable-constraint exoskeleton for stability and support with functional neuromuscular stimulation (FNS) to contract the paralyzed muscles to drive limb movement. This self-contained HNP was operated by an onboard controller that sampled sensor signals, generated appropriate commands to both the exoskeletal constraints and integrated stimulator, and transmitted data wirelessly via Bluetooth to an off-board computer for real-time monitoring and recording for offline analysis. The subject selected the desired function (i.e. standing up, stepping, or sitting down) by means of a wireless finger switch that communicated with the onboard controller. Within the stepping function, a gait event detector supervisory controller transitioned between the different phases of gait such as double stance, swing, and weight acceptance based on signals from sensors incorporated into the exoskeleton. The different states of the control system governed the locking and unlocking of the exoskeletal hip and knee joints as well as the stimulation patterns activating hip and knee flexor or extensor muscles at the appropriate times and intensities to enable stepping. This study was one of our first successful implementations of the self-contained "muscle-first" HNP and successfully restored gait to an individual with motor complete mid-thoracic paraplegia.

Powered Lower-Limb Exoskeletons to Restore Gait for Individuals with Paraplegia - a Review.

Individuals with paraplegia due to spinal cord injury rank restoration of walking high on the list of priorities to improving their quality of life. Powered lower-limb exoskeleton technology provides the ability to restore standing up, sitting down, and walking movements for individuals with paraplegia. The robotic exoskeletons generally have electrical motors located at the hip and knee joint centers, which move the wearers' lower limbs through the appropriate range of motion for gait according to control systems using either trajectory control or impedance control. Users of exoskeletons are able to walk at average gait speeds of 0.26 m/s and distances ranging between 121-171 m. However, the achieved gait speeds and distances fall short of those required for full community ambulation (0.8 m/s and at least 230 m), restricting use of the devices to limited community use with stand-by assist or supervised rehabilitation settings. Improvement in the gait speed and distance may be achievable by combining a specially designed powered exoskeleton with neuromuscular stimulation technologies resulting in a hybrid system that fully engages the user and achieves the necessary requirements to ambulate in the community environment with benefits of muscle contraction.

Functional electrical stimulation and spinal cord injury.

Spinal cord injuries (SCI) can disrupt communications between the brain and the body, resulting in loss of control over otherwise intact neuromuscular systems. Functional electrical stimulation (FES) of the central and peripheral nervous system can use these intact neuromuscular systems to provide therapeutic exercise options to allow functional restoration and to manage medical complications following SCI. The use of FES for the restoration of muscular and organ functions may significantly decrease the morbidity and mortality following SCI. Many FES devices are commercially available and should be considered as part of the lifelong rehabilitation care plan for all eligible persons with SCI.

Understanding stand-to-sit maneuver: implications for motor system neuroprostheses after paralysis.

Standing up, standing, and walking functions can be restored to people with spinal cord injury by contracting the paralyzed hip, knee, and ankle muscles with electrical stimulation. Restoring these functions using electrical stimulation requires controlled activation to provide coordinated movements. However, the stand-to-sit (STS) maneuver involves eccentric contractions of the quadriceps to control lowering of the body to the seated position, which is difficult to achieve with stimulation alone and presents unique challenges to lower-limb neuroprostheses. In this study, we examined the biomechanics of the STS maneuver in five nondisabled individuals and five users of an implanted neuroprosthesis. Neuroprosthesis users relied heavily on their upper limbs during STS, with peak supporting forces approximately 25% body weight, and exhibited an average vertical acceleration at the impact six times higher than that of the nondisabled subjects (p < 0.001). Sitting with stimulation resulted in impact forces at initial contact with the seating surface averaging 1.4 times body weight and representing an average of twice the impact forces of the nondisabled subjects (p < 0.001). These results indicate a need for additional interventions to better control descent, minimize impact, and gently transition from standing to sitting to achieve a more natural movement and reduce the risk of injury.