BackgroundFunctional 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.MethodsThe 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.ResultsThe 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.ConclusionsA 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.
The development of a hybrid system for people with spinal cord injuries is described. The system includes implanted neural stimulation to activate the user's otherwise paralyzed muscles, an exoskeleton with electromechanical actuators at the hips and knees, and a sensory and control system that integrates both components. We are using a muscle-first approach: The person's muscles are the primary motivator for his/her joints and the motors provide power assistance. This design philosophy led to the development of high efficiency, low friction joint actuators, and feed-forward, burst-torque control. The system was tested with two participants with spinal cord injury (SCI) and unique implanted stimulation systems. Torque burst addition was found to increase gait speed. The system was found to satisfy the main design requirements as laid out at the outset.
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.
This study assessed the metabolic energy consumption of walking with the external components of a “Muscle-First” Motor Assisted Hybrid Neuroprosthesis (MAHNP), which combines implanted neuromuscular stimulation with a motorized exoskeleton. The “Muscle-First” approach prioritizes generating motion with the wearer's own muscles via electrical stimulation with the actuators assisting on an as-needed basis. The motorized exoskeleton contributes passive resistance torques at both the hip and knee joints of 6Nm and constrains motions to the sagittal plane. For the muscle contractions elicited by neural stimulation to be most effective, the motorized joints need to move freely when not actively assisting the desired motion. This study isolated the effect of the passive resistance or “friction” added at the joints by the assistive motors and transmissions on the metabolic energy consumption of walking in the device. Oxygen consumption was measured on six able-bodied subjects performing 6 min walk tests at three different speeds (0.4, 0.8, and 1.2 m/s) under two different conditions: one with the motors producing no torque to compensate for friction, and the other having the motors injecting power to overcome passive friction based on a feedforward friction model. Average oxygen consumption in the uncompensated condition across all speeds, measured in Metabolic Equivalent of Task (METs), was statistically different than the friction compensated condition. There was an average decrease of 8.8% for METs and 1.9% for heart rate across all speeds. While oxygen consumption was reduced when the brace performed friction compensation, other factors may have a greater contribution to the metabolic energy consumption when using the device. Future studies will assess the effects of gravity compensation on the muscular effort required to lift the weight of the distal segments of the exoskeleton as well as the sagittal plane constraint on walking motions in individuals with spinal cord injuries (SCI).
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