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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.

Objective: Explore whether electromyography (EMG) control of electrical stimulation for walking after incomplete spinal cord injury (SCI) can affect ability to modulate speed and alter gait spatial-temporal parameters compared to cyclic repetition of pre-programmed stimulation., Design: Single case study with subject acting as own concurrent control. Setting Hospital-based biomechanics laboratory., Participants: Single subject with C6 AIS D SCI using an implanted neuroprosthesis for walking. Interventions Lower extremity muscle activation via an implanted system with two different control methods: (1) pre-programmed pattern of stimulation, and (2) EMG-controlled stimulation based on signals from the gastrocnemius and quadriceps., Outcome Measures: Gait speed, distance, and subjective rating of difficulty during 2-minute walks. Range of walking speeds and associated cadences, stride lengths, stride times, and double support times during quantitative gait analysis., Results: EMG control resulted in statistically significant increases in both walking speed and distance (P < 0.001) over cyclic stimulation during 2-minute walks. Maximum walking speed with EMG control (0.48 m/second) was significantly (P < 0.001) faster than the fastest automatic pattern (0.39 m/second), with increased cadence and decreased stride and double support times (P < 0.000) but no change in stride length (z = -0.085; P = 0.932). The slowest walking with EMG control (0.25 m/second) was virtually indistinguishable from the slowest with automatic cycling (z = -0.239; P = 0.811)., Conclusion: EMG control can increase the ability to modulate comfortable walking speed over pre-programmed cyclic stimulation. While control methods did not differ at the lowest speed, EMG-triggered stimulation allowed significantly faster walking than cyclic stimulation. The expanded range of available walking speeds could permit users to better avoid obstacles and naturally adapt to various environments. Further research is required to definitively determine the robustness, generalizability, and functional implications of these results.

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.

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.

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. [ABSTRACT FROM AUTHOR]

Objective: The objective of this work was to quantify the effects of a fully implanted pulse generator to activate or augment actions of hip, knee, and ankle muscles after stroke. Design: The subject was a 64-year-old man with left hemiparesis resulting from hemorrhagic stroke 21 months before participation. He received an 8-channel implanted pulse generator and intramuscular stimulating electrodes targeting unilateral hip, knee, and ankle muscles on the paretic side. After implantation, a stimulation pattern was customized to assist with hip, knee, and ankle movement during gait. The subject served as his own concurrent and longitudinal control with and without stimulation. Outcome measures included 10-m walk and 6-minute timed walk to assess gait speed, maximum walk time, and distance to measure endurance, and quantitative motion analysis to evaluate spatial-temporal characteristics. Assessments were repeated under 3 conditions: (1) volitional walking at baseline, (2) volitional walking after training, and (3) walking with stimulation after training. Results: Volitional gait speed improved with training from 0.29 m/s to 0.35 m/s and further increased to 0.72 m/s with stimulation. Most spatial-temporal characteristics improved and represented more symmetrical and dynamic gait. Conclusions: These data suggest that a multijoint approach to implanted neuroprostheses can provide clinically relevant improvements in gait after stroke. [ABSTRACT FROM AUTHOR]

A patient with multiple sclerosis-related gait dysfunction was followed over the course of his disease. Despite aggressive treatment, he developed significant weakness in ankle dorsiflexors and hip and knee flexors and was no longer capable of consistently taking a step on his own. With electrical stimulation of hip and knee flexors and ankle dorsiflexors using implanted electrodes, he was able to consistently walk short distances as far as 30 m, thus significantly improving his Expanded Disability Status Scale score. This case study supports further exploration into the potential benefits of an implanted pulse generator to ameliorate gait dysfunction and improve quality of life for people with multiple sclerosis. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The purpose of this single-subject study was to determine the neurotherapeutic and neuroprosthetic effects of an implanted functional electrical stimulation (FES) system designed to facilitate walking in an individual with a long-standing motor and sensory incomplete spinal cord injury. An implanted pulse generator and eight intramuscular stimulating electrodes were installed unilaterally, activating weak or paralyzed hip flexors, hip and knee extensors, and ankle dorsiflexors during 36 sessions of gait training with FES. The neurotherapeutic effects were assessed by a comparison of pre- and posttraining volitional walking. The neuroprosthetic effects were assessed by a comparison of posttraining volitional and FES-assisted walking. Treatment resulted in significant (p < 0.005) volitional improvements in 6-minute walking distance and speed, speed during maximum walk, double support time, and 10 m walking speed. Posttraining FES-assisted walking resulted in significant additional improvements in all these measures, except 10 m walking speed. When the subject was using FES-assisted gait, maximum walking distance, peak knee flexion in swing, peak ankle dorsiflexion in swing, and knee extension moment also significantly increased. Neuroprosthetic gains were sufficient to enable the subject to advance from household ambulation to limited community ambulation. Additionally, the subject could perform multiple walks per day when using FES-assisted gait, which was impossible with volitional effort alone. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]