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.

A neuroprosthesis for control of seated balance after spinal cord injury.

BACKGROUND: A major desire of individuals with spinal cord injury (SCI) is the ability to maintain a stable trunk while in a seated position. Such stability is invaluable during many activities of daily living (ADL) such as regular work in the home and office environments, wheelchair propulsion and driving a vehicle. Functional neuromuscular stimulation (FNS) has the ability to restore function to paralyzed muscles by application of measured low-level currents to the nerves serving those muscles. METHODS: A feedback control system for maintaining seated balance under external perturbations was designed and tested in individuals with thoracic and cervical level spinal cord injuries. The control system relied on a signal related to the tilt of the trunk from the vertical position (which varied between 1.0 ≡ erect posture and 0.0 ≡ most forward flexed posture) derived from a sensor fixed to the sternum to activate the user's own hip and trunk extensor muscles via an implanted neuroprosthesis. A proportional-derivative controller modulated stimulation between trunk tilt values indicating deviation from the erect posture and maximum desired forward flexion. Tests were carried out with external perturbation forces set at 35%, 40% and 45% body-weight (BW) and maximal forward trunk tilt flexion thresholds set at 0.85, 0.75 and 0.70. RESULTS: Preliminary tests in a case series of five subjects show that the controller could maintain trunk stability in the sagittal plane for perturbations up to 45% of body weight and for flexion thresholds as low as 0.7. The mean settling time varied across subjects from 0.5(±0.4) and 2.0 (±1.1) seconds. Mean response time of the feedback control system varied from 393(±38) ms and 536(±84) ms across the cohort. CONCLUSIONS: The results show the high potential for robust control of seated balance against nominal perturbations in individuals with spinal cord injury and indicates that trunk control with FNS is a promising intervention for individuals with SCI.

Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion.

Objective: Wheelchair safety is of great importance since falls from wheelchairs are prevalent and often have devastating consequences. We developed an automatic system to detect destabilizing events during wheelchair propulsion under real-world conditions and trigger neural stimulation to stiffen the trunk to maintain seated postures of users with paralysis.Design: Cross-over interventionSetting: Laboratory and community settingsParticipants: Three able-bodied subjects and three individuals with SCI with previously implanted neurostimulation systemsInterventions: An algorithm to detect wheelchair sudden stops was developed. This was used to randomly trigger trunk extensor stimulation during sudden stops eventsOutcome Measures: Algorithm success and false positive rates were determined. SCI users rated each condition on a seven-point Usability Rating Scale to indicate safety.Results: The system detected sudden stops with a success rate of over 93% in community settings. When used to trigger trunk neurostimulation to ensure stability, the implant recipients consistently reported feeling safer (P<.05 for 2/3 subjects) with the system while encountering sudden stops as indicated by a 1-3 point change in safety rating.Conclusion: These preliminary results suggest that this system could monitor wheelchair activity and only apply stabilizing neurostimulation when appropriate to maintain posture. Larger scale, unsupervised and longer-term trials at home and in the community are indicated. This system could be generalized and applied to individuals without an implanted stimulation by utilizing surface stimulation, or by actuating a mechanical restraint when necessary, thus allowing unrestricted trunk movements and only restraining the user when necessary to ensure safety.Trial Registration: NCT01474148.

Development and deployment of cyclical focal muscle vibration system to improve walking performance in multiple sclerosis.

Vibration, a potent mechanical stimulus for activating muscle spindle primary afferents, may improve gait performance in persons with multiple sclerosis (MS), but has yet to be developed and deployed for multiple leg muscles with application during walking training. This study explored the development of a cyclic focal muscle vibration (FMV) system, and the deployment feasibility to correct MS walking swing phase deficits in order to determine whether this intervention warrants comprehensive study. The system was deployed during twelve, two-hour sessions of walking with cyclic FMV over six weeks. Participants served as their own control. Blood pressure, heart rate, walking speed, kinematics (peak hip, knee and ankle angles during swing), toe clearance, and step length were measured before and after deployment with blood pressure and heart rate monitored during deployment. During system deployment, there were no untoward sensations and physiological changes in blood pressure and heart rate, and volitional improvements were found in walking speed, improved swing phase kinematics, toe clearance and step length. This FMV training system was developed and deployed to improve joint flexion during walking in those with MS, and it demonstrated feasibility and benefits. Further study will determine the most effective vibration frequency and dose, carryover effects, and those most likely to benefit from this intervention.

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.

Accelerometer-based step initiation control for gait-assist neuroprostheses.

Electrical activation of paralyzed musculature can generate or augment joint movements required for walking after central nervous system trauma. Proper timing of stimulation relative to residual volitional control is critical to usefully affecting ambulation. This study evaluates three-dimensional accelerometers and customized algorithms to detect the intent to step from voluntary movements to trigger stimulation during walking in individuals with significantly different etiologies, mobility limitations, manual dexterities, and walking aids. Three individuals with poststroke hemiplegia or partial spinal cord injury exhibiting varying gait deficits were implanted with multichannel pulse generators to provide joint motions at the hip, knee, and ankle. An accelerometer integrated into the external control unit was used to detect heel strike or walker movement, and wireless accelerometers were used to detect crutch strike. Algorithms were developed for each sensor location to detect intent to step to progress through individualized stimulation patterns. Testing these algorithms produced detection accuracies of at least 90% on both level ground and uneven terrain. All participants use their accelerometer-triggered implanted gait systems in the community; the validation/system testing was completed in the hospital. The results demonstrated that safe, reliable, and convenient accelerometer-based step initiation can be achieved regardless of specific gait deficits, manual dexterities, and walking aids.

Feasibility of a Hydraulic Power Assist System for Use in Hybrid Neuroprostheses.

Feasibility of using pressurized hydraulic fluid as a source of on-demand assistive power for hybrid neuroprosthesis combining exoskeleton with functional neuromuscular stimulation was explored. Hydraulic systems were selected as an alternative to electric motors for their high torque/mass ratio and ability to be located proximally on the exoskeleton and distribute power distally to assist in moving the joints. The power assist system (PAS) was designed and constructed using off-the-shelf components to test the feasibility of using high pressure fluid from an accumulator to provide assistive torque to an exoskeletal hip joint. The PAS was able to provide 21 Nm of assistive torque at an input pressure of 3171 kPa with a response time of 93 ms resulting in 32° of hip flexion in an able-bodied test. The torque output was independent of initial position of the joint and was linearly related to pressure. Thus, accumulator pressure can be specified to provide assistive torque as needed in exoskeletal devices for walking or stair climbing beyond those possible either volitionally or with electrical stimulation alone.

Forward stair descent with hybrid neuroprosthesis after paralysis: Single case study demonstrating feasibility.

The ability to negotiate stairs is important for community access and independent mobility but requires more effort and strength than level walking. For this reason, previous attempts to utilize functional neuromuscular stimulation (FNS) to restore stair navigation after spinal cord injury (SCI) have had limited success and are not readily generalizable. Stair descent is particularly challenging because it requires energy absorption via eccentric muscle contractions, a task not easily accomplished with FNS. This article presents the design and initial testing of a hybrid neuroprosthesis with a variable impedance knee mechanism (VIKM-HNP) for stair descent. Using a 16-channel percutaneous FNS system, a muscle activation pattern was synthesized to descend stairs with the VIKM-HNP in a step-by-step fashion. A finite state control system was implemented to deactivate knee extensor stimulation and utilize the VIKM-HNP to absorb energy and regulate descent speed. Feasibility testing was performed on one individual with complete thoracic-level SCI. Stair descent was achieved with maximum upper-limb forces of less than 45% body weight compared with previously reported value of 70% with FNS only. The experiments also provided insight into design requirements for future hybrid systems for stair navigation, the implications of which are discussed.

Sensor-based hip control with hybrid neuroprosthesis for walking in paraplegia.

The objectives of this study were to test whether a hybrid neuroprosthesis (HNP) with an exoskeletal variable-constraint hip mechanism (VCHM) combined with a functional neuromuscular stimulation (FNS) controller can maintain upright posture with less upper-limb support and improve gait speed as compared with walking with either an isocentric reciprocating gait orthosis (IRGO) or FNS only. The results show that walking with the HNP significantly reduced forward lean in FNS-only walking and the maximum upper-limb forces by 42% and 19% as compared with the IRGO and FNS-only gait, respectively. Walking speed increased significantly with VCHM as compared with 1:1 reciprocal coupling and by 15% when using the sensor-based FNS controller as compared with HNP with fixed baseline stimulation without the controller active.

Finite state control of a variable impedance hybrid neuroprosthesis for locomotion after paralysis.

We have previously reported on a novel variable impedance knee mechanism (VIKM). The VIKM was designed as a component of a hybrid neuroprosthesis to regulate knee flexion. The hybrid neuroprosthesis is a device that uses a controllable brace to support the body against collapse while stimulation provides power for movement. The hybrid neuroprosthesis requires a control system to coordinate the actions of the VIKM with the stimulation system; the development and evaluation of such a controller is presented. Brace mounted sensors and a baseline open loop stimulation pattern are utilized as control signals to activate the VIKM during stance phase while simultaneously modulating muscle stimulation in an on-off fashion. The objective is twofold: reduce the amount of stimulation necessary for walking while simultaneously restoring more biologically correct knee motion during stance using the VIKM. Custom designed hardware and software components were developed for controller implementation. The VIKM hybrid neuroprosthesis (VIKM-HNP) was evaluated during walking in one participant with thoracic level spinal cord injury. In comparison to walking with functional neuromuscular stimulation alone, the VIKM-HNP restored near normal stance phase knee flexion during loading response and pre-swing phases while decreasing knee extensor stimulation by up to 40%.

Development of a self-contained accelerometry based system for control of functional electrical stimulation in hemiplegia.

For stroke patients, functional electrical stimulation (FES) has been shown in the past to greatly reduce gait impairments. A critical element of the success of this intervention is accurate and reliable triggering of the stimulation for step initiation. Foot switches are the most commonly used devices for triggering hemiplegic FES gait, but they have been known to produce unreliable results and degrade over time. This paper outlines the development of a self-contained accelerometry-based gait stimulation system that can be worn around the waist and unlike other systems, adds no additional hardware or equipment to don or doff. An acceleration algorithm was developed and shown to have significantly shorter heel strike detection delays than when detecting with a heel sensor which could lead to improved stimulation timing for step initiation.

Stance control knee mechanism for lower-limb support in hybrid neuroprosthesis.

A hydraulic stance control knee mechanism (SCKM) was developed to fully support the knee against flexion during stance and allow uninhibited motion during swing for individuals with paraplegia using functional neuromuscular stimulation (FNS) for gait assistance. The SCKM was optimized for maximum locking torque for body-weight support and minimum resistance when allowing for free knee motion. Ipsilateral and contralateral position and force feedback were used to control the SCKM. Through bench and nondisabled testing, the SCKM was shown to be capable of supporting up to 70 N-m, require no more than 13% of the torque achievable with FNS to facilitate free motion, and responsively and repeatedly unlock under an applied flexion knee torque of up to 49 N-m. Preliminary tests of the SCKM with an individual with paraplegia demonstrated that it could support the body and maintain knee extension during stance without the stimulation of the knee extensor muscles. This was achieved without adversely affecting gait, and knee stability was comparable to gait assisted by knee extensor stimulation during stance.

Development of hybrid orthosis for standing, walking, and stair climbing after spinal cord injury.

This study explores the feasibility of a hybrid system of exoskeletal bracing and multichannel functional electrical stimulation (FES) to facilitate standing, walking, and stair climbing after spinal cord injury (SCI). The orthotic components consist of electromechanical joints that lock and unlock automatically to provide upright stability and free movement powered by FES. Preliminary results from a prototype device on nondisabled and SCI volunteers are presented. A novel variable coupling hip-reciprocating mechanism either acts as a standard reciprocating gait orthosis or allows each hip to independently lock or rotate freely. Rotary actuators at each hip are configured in a closed hydraulic circuit and regulated by a finite state postural controller based on real-time sensor information. The knee mechanism locks during stance to prevent collapse and unlocks during swing, while the ankle is constrained to move in the sagittal plane under FES-only control. The trunk is fixed in a rigid corset, and new ankle and trunk mechanisms are under development. Because the exoskeletal control mechanisms were built from off-the-shelf components, weight and cosmesis specifications for clinical use have not been met, although the power requirements are low enough to provide more than 4 hours of continuous operation with standard camcorder batteries.