Modified implanted drop foot stimulator system with graphical user interface for customised stimulation pulse-width profiles

A modified implanted drop foot stimulator that allows cyclic modulation of the stimulation pulse-width during gait has been developed. Stimulation was on two channels of a four-channel 12 polar cuff electrode. The stimulator allowed modulation of stimulation pulse-width, between 0 and 255μs, on both channels throughout the swing and stance phases of gait. Stimulation was applied between 17 and 40 Hz. The clinician can specify an infinite range of stimulation profiles on a desktop computer, using a user-friendly LabVIEW^TM interface. The desktop program generated a stimulation profile table of 100 values, which was then downloaded to the drop foot stimulator. As each phase of gait imposed different biomechanical demands on the ankle dorsiflexor muscles, different stimulation intensities were desirable, throughout gait, to match these demands. Moreover, as the gait of each person with hemiplegia is unique, the biomechanical demands imposed throughout the gait cycle for each user of a drop foot stimulator are unique. This stimulator architecture allowed the clinician to, specify stimulation intensities individually, at each phase of the gait cycle for each drop foot stimulator user. The stimulator was evaluated on a male hemiplegic subject. It was used to increase the stimulation pulse-width by 150% at 5% of gait cycle prior to heel strike. The system performed well, with the ankle angle at heel strike increasing by 5° owing to this increased pulse-width.     

Bipedal gait model for precise gait recognition and optimal triggering in foot drop stimulator: a proof of concept

Electrical stimulators are often prescribed to correct foot drop walking. However, commercial foot drop stimulators trigger inappropriately under certain non-gait scenarios. Past researches addressed this limitation by defining stimulation control based on automaton of a gait cycle executed by foot drop of affected limb/foot only. Since gait is a collaborative activity of both feet, this research highlights the role of normal foot for robust gait detection and stimulation triggering. A novel bipedal gait model is proposed where gait cycle is realized as an automaton based on concurrent gait sub-phases (states) from each foot. The input for state transition is fused information from feet-worn pressure and inertial sensors. Thereafter, a bipedal gait model-based stimulation control algorithm is developed. As a feasibility study, bipedal gait model and stimulation control are evaluated in real-time simulation manner on normal and simulated foot drop gait measurements from 16 able-bodied participants with three speed variations, under inappropriate triggering scenarios and with foot drop rehabilitation exercises. Also, the stimulation control employed in commercial foot drop stimulators and single foot gait-based foot drop stimulators are compared alongside. Gait detection accuracy (98.9%) and precise triggering under all investigations prove bipedal gait model reliability. This infers that gait detection leveraging bipedal periodicity is a promising strategy to rectify prevalent stimulation triggering deficiencies in commercial foot drop stimulators.

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Graphical abstract Bipedal information-based gait recognition and stimulation triggering

     

Cycle-to-cycle control of swing phase of paraplegic gait induced by surface electrical stimulation

Parameterised swing phase of gait in paraplegics was obtained using surface electrical stimulation of the hip flexors, hamstrings and quadriceps; the hip flexors were stimulated to obtain a desired hip angle range, the hamstrings to provide foot clearance in the forward swing, and the quadriceps to acquire knee extension at the end of the swing phase. We report on two main aspects; optimisation of the initial stimulation parameters, and parameter adaption (control). The initial stimulation patterns were experimentally optimised in two paraplegic subjects using a controlled stand device, resulting in an initial satisfactory swinging motion in both subjects. Intersubject differences appeared in the mechanical output (torque joint) per muscle group. During a prolonged open-loop controlled trial with the optimised but unregulated stimulation onsets and burst duration for the three muscle groups, the hip angle range per cycle initially increased above the desired value and subsequently decreased below it. The mechanical performance of the hamstrings and quadriceps remained relatively unaffected. A cycle-to-cycle controller was then designed, operating on the basis of the hip angle ranges obtained in previous swings. This controller successfully adapted the burst duration of the hip flexors to maintain the desired hip angle range.     

The adaptive drop foot stimulator – Multivariable learning control of foot pitch and roll motion in paretic gait

Many stroke patients suffer from the drop foot syndrome, which is characterized by a limited ability to lift (the lateral and/or medial edge of) the foot and leads to a pathological gait. In this contribution, we consider the treatment of this syndrome via functional electrical stimulation (FES) of the peroneal nerve during the swing phase of the paretic foot. A novel three-electrodes setup allows us to manipulate the recruitment of m. tibialis anterior and m. fibularis longus via two independent FES channels without violating the zero-net-current requirement of FES. We characterize the domain of admissible stimulation intensities that results from the nonlinearities in patients’ stimulation intensity tolerance. To compensate most of the cross-couplings between the FES intensities and the foot motion, we apply a nonlinear controller output mapping. Gait phase transitions as well as foot pitch and roll angles are assessed in realtime by means of an Inertial Measurement Unit (IMU). A decentralized Iterative Learning Control (ILC) scheme is used to adjust the stimulation to the current needs of the individual patient. We evaluate the effectiveness of this approach in experimental trials with drop foot patients walking on a treadmill and on level ground. Starting from conventional stimulation parameters, the controller automatically determines individual stimulation parameters and thus achieves physiological foot pitch and roll angle trajectories within at most two strides.     

The application of inertial measurements unit for the clinical evaluation and assessment of gait events

Foot drop is one of the common gait abnormalities which are difficult to detect, diagnose and evaluate. While various gait monitoring systems are available, many are computationally expensive and difficult to implement outside laboratory environments. This study introduces an in-house designed system based on inertial measurement units to capture the gait symptoms, specifically in the case of foot drop symptoms. The system specification and communication results, as well as filtering methods are discussed. Also, the pitch angle of thigh, shank and foot from a subject with no reported foot problem have been compared (gathered from identical equipment under similar conditions) to the same angle from a foot drop subject.     

Three dimensional inertial sensing of foot movements for automatic tuning of a two-channel implantable drop-foot stimulator

A three dimensional inertial sensing system for measuring foot movements during gait is proposed and tested. It can form the basis for an automated tuning system for a two-channel implantable drop-foot stimulator. The foot orientation and position during the swing phase of gait can be reconstructed on the basis of three-dimensional measurement of acceleration and angular velocity, using initial and final conditions during mid-stance. The foot movements during gait of one stroke person using the implanted two-channel stimulator were evaluated for several combinations of stimulation parameters for both channels. The reconstructed foot movements during gait in this person indicated that the channel stimulating the deep peroneal nerve contributes mainly to dorsiflexion and provides some reduction of inversion seen without stimulation, while the channel activating the superficial peroneal nerve mainly provides additional reduction of inversion. This agrees with anatomical knowledge about the function of the muscles activated by both branches of the peroneal nerve. The inertial sensor method is expected to be useful for the clinical evaluation of foot movements during gait supported by the two-channel drop-foot stimulator. Furthermore, it is expected to be applicable for the automated balancing of the two stimulation channels to ensure optimal support of gait.     

A versatile drop foot stimulator for research applications

Drop Foot Stimulators are used to correct hemiplegic drop foot by synchronising the application of Functional Electrical Stimulation (FES) of the Common Peroneal Nerve (CPN) to the swing phase of the gait cycle. A research Drop Foot Stimulator (DFS) has been developed with a very flexible architecture to enable the investigation of a variety of gait-correction strategies. The portable unit has been carefully designed to optimise functionality while keeping its size and power consumption to a minimum. The device has two channels of stimulation, with all parameters of stimulation for each channel independently programmable. Four analogue and four digital sensor input channels are provided with a wide variety of sensor types possible. A microcontroller core is utilised to enable the implementation of different control algorithms. A PC-based user interface enables easy programming of the system configuration.     

Methods for gait event detection and analysis in ambulatory systems

After stroke, hemiparesis is a common problem resulting in very individual needs for walking assistance. Often patients suffer from foot drop, i.e. inability to lift the foot from the ground during the swing phase of walking. Functional electrical stimulation is commonly used to correct foot drop. For all supporting stimulation devices, it is vital to adequately detect the gait events, which is traditionally obtained by a foot switch placed under the heel. To investigate present methods of gait analysis and detection for use in ambulatory rehabilitation systems, we carried out a meta-analysis on research studies. We found various sensors and sensor combinations capable of analyzing gait in ambulatory settings, ranging form simple force based binary switches to complex setups involving multiple inertial sensors and advanced algorithms. However additional effort is needed to minimize donning/doffing efforts, to overcome cosmetical aspects, and to implement those systems into closed loop ambulatory devices.     

Electrical stimulation of skeletal muscle—A study of muscle as an actuator

In many forms of disability in humans due to paralysis, it appears possible to regain some measure of function through direct electrical stimulation of paralysed muscles. The work described in this paper represents some of the first steps taken in a broad research program toward controlled electrical stimulation of muscles in human beings. From an engineering point of view, it is important to characterize the muscle as an operational element. This means that the force and movement responses to input stimuli must be analysed and modeled so that effective control systems can be designed. Such analytic models must take into account physiologic factors such as metabolic capability, maintenance and regeneration of muscle tissue, and comfort and fatigue factors. Most of the data reported herein have been obtained from normal human beings. In general, comfort and pain have been used to define limits which are assumed to be equally applicable to involved persons. Initial studies have been directed to determine the nature of electrical signals which produce the maximum stimulation effects with minimum discomfort and pain. Constant current stimulation was chosen as an optimum mode. Studies were made to determine the nature and location of motor points. Plots showing isometric torque developed about the elbow as a function of stimulation frequency and intensity have been made. Single muscle twitch responses were recorded and a mathematical model derived for a single muscle twitch. Tetanic torque was predicted from single muscle twitch response. A mathematical model for a total muscle which is consistent with the concept of a summation of muscle twitches to produce tetanic contraction has been proposed.     

Contribution of muscle afferents to prolonged flexion withdrawal reflexes in human spinal cord injury

The contribution of force-sensitive muscular afferents to prolonged flexion withdrawal reflexes, or flexor spasms, after human spinal cord injury (SCI) was investigated. In three separate experimental conditions, flexion reflexes were triggered in subjects with SCI using trains of electrocutaneous stimuli delivered at the foot and lower leg and compared with reflexes elicited via intramuscular (i.m.) electrical stimuli. In the first experiment, flexion reflexes were elicited using i.m. stimuli to the tibialis anterior (TA) in the majority of subjects tested. The ratio of peak isometric ankle to hip torques during i.m.-triggered reflexes were proportionally similar to those evoked by electrocutaneous foot or shank stimulation, although the latency to onset and peak flexion torques were significantly longer with i.m. stimulation. In the second experiments, the amplitude and frequency of i.m. TA stimulation were varied to alter the stimulus-induced muscle torque. Peak ankle and hip torques generated during the flexion reflex responses were correlated to a greater extent with stimulus-induced muscle torques as compared with the modulated stimulus parameters. In the third experimental series, i.m. stimuli delivered to the gastrocnemius (GS) elicited flexion reflexes in approximately half of the subjects tested. The combined data indicate a potentially prominent role of the stimulus-induced muscle contraction to the magnitude and latency of flexor reflex behaviors after i.m. TA stimulation. Results after i.m. GS stimulation indicate multi-joint flexion reflexes can also be elicited, although to a lesser extent than i.m. TA stimulation.     

Limitations of relaxation kinetics on muscular work

Aim: Positive net work produced during cyclic contractions is partially limited by relaxation kinetics, which to date, have not been directly investigated. Therefore, the purpose of this investigation was to determine the influence of relaxation kinetics on cyclic work. Methods: Soleus muscles of four cats were isolated and subjected to a series of work loops (0.5, 1, 1.5 and 2 Hz cycle frequencies) during which stimulation terminated prior to the end of the shortening phase to allow for complete muscle relaxation and matched discrete sinusoidal shortening contractions during which stimulation remained on until the completion of the shortening phase. Muscle length changes during these protocols were centred on optimum length and were performed across muscle lengths that represented walking gait. Results: When muscle excursions were centred on L_o relaxation kinetics decreased muscular work by 2.8 ± 0.8%, 12.1 ± 4.1%, 27.9 ± 4.5% and 40.1 ± 5.9% for 0.5, 1, 1.5 and 2 Hz respectively. However, relaxation kinetics did not influence muscular work when muscle excursions represented walking gait. In addition, muscular work produced at muscle lengths associated with walking gait was less than the work produced across L_o (55.7 ± 20.0%, 53.5 ± 21.0%, and 50.1 ± 22.0% for 0.5, 1 and 1.5 Hz respectively). Conclusion: These results imply that relaxation kinetics are an important factor that limit the ability of muscle to produce work; however, the influence of relaxation kinetics on physiological function may depend on the relation between the optimum length and natural excursion of a muscle.     

How Crouch Gait Can Dynamically Induce Stiff-Knee Gait

Children with cerebral palsy frequently experience foot dragging and tripping during walking due to a lack of adequate knee flexion in swing (stiff-knee gait). Stiff-knee gait is often accompanied by an overly flexed knee during stance (crouch gait). Studies on stiff-knee gait have mostly focused on excessive knee muscle activity during (pre)swing, but the passive dynamics of the limbs may also have an important effect. To examine the effects of a crouched posture on swing knee flexion, we developed a forward-dynamic model of human walking with a passive swing knee, capable of stable cyclic walking for a range of stance knee crouch angles. As crouch angle during stance was increased, the knee naturally flexed much less during swing, resulting in a ‘stiff-knee’ gait pattern and reduced foot clearance. Reduced swing knee flexion was primarily due to altered gravitational moments around the joints during initial swing. We also considered the effects of increased push-off strength and swing hip flexion torque, which both increased swing knee flexion, but the effect of crouch angle was dominant. These findings demonstrate that decreased knee flexion during swing can occur purely as the dynamical result of crouch, rather than from altered muscle function or pathoneurological control alone.     

Microprocessor-based gait analysis system to retrain Trendelenburg gait

A microprocessor-based gait analysis system is described that uses two electromyogram (EMG) amplifiers, two foot switches and an audio feedback device to allow the retraining of one type of improper gait, where the hip abductors (gluteus medius muscles) are weak on one side of the body, causing the opposite hip to drop during the swing phase of gait (Trendelenburg gait). As the abnormality is strictly on one side of the body in most people, the circuitry is minimised, as gait can be analysed by only comparing muscle activity in the affected gluteus medius muscle with that in the unaffected gluteus medius muscle, through the EMG. Two foot contact switches are used to help assess timing of the step cycle. If gait is different on the two sides of the body, an audio cue directs the patient to correct the abnormality by increasing activity on the affected side. The device is tested on five patients. Trendelenburg gait is reduced by an average of 29 degrees through the use of the device. The average stride length at the beginning of the study is 0.32±0.3 m. By the end of the study, the stride length is increased to 0.45±0.2m for the entire group of five subjects. The speed of gait has increased from 1.6±0.4 kmh⁻¹ to 3.1±0.5 kmh⁻¹.     

A system for the delivery of programmable, adaptive stimulation intensity envelopes for drop foot correction applications

We describe the design of an intelligent drop foot stimulator unit for use in conjunction with a commercial neuromuscular electrical nerve stimulation (NMES) unit, the NT2000. The developed micro-controller unit interfaces to a personal computer (PC) and a graphical user interface (GUI) allows the clinician to graphically specify the shape of the stimulation intensity envelope required for a subject undergoing drop foot correction. The developed unit is based on the ADuC812S micro-controller evaluation board from Analog Devices and uses two force sensitive resistor (FSR) based foot-switches to control application of stimulus. The unit has the ability to display to the clinician how the stimulus intensity envelope is being delivered during walking using a data capture capability. The developed system has a built-in algorithm to dynamically adjust the delivery of stimulus to reflect changes both within the gait cycle and from cycle to cycle. Thus, adaptive control of stimulus intensity is achieved.     

Dynamic stress analysis of below-knee drop foot braces; Studies on patients with paralysis of the lower limb

A stress analysis was carried out on below-knee braces of standard design on four patients suffering from drop foot due to poliomyelitis. The maximum stresses were recorded during the stance phase of gait. A comparison was made with stresses analysed in similar braces worn by a normal subject. It was concluded that the stresses evolved during the stance phase might be reduced if the brace were redesigned so that the drop-foot preventive mechanism operated only during the swing phase.     

An investigation of the dynamic relationship between navicular drop and first metatarsophalangeal joint dorsal excursion

The modern human foot is a complex biomechanical structure that must act both as a shock absorber and as a propulsive strut during the stance phase of gait. Understanding the ways in which foot segments interact can illuminate the mechanics of foot function in healthy and pathological humans. It has been proposed that increased values of medial longitudinal arch deformation can limit metatarsophalangeal joint excursion via tension in the plantar aponeurosis. However, this model has not been tested directly in a dynamic setting. In this study, we tested the hypothesis that during the stance phase, subtalar pronation (stretching of the plantar aponeurosis and subsequent lowering of the medial longitudinal arch) will negatively affect the amount of first metatarsophalangeal joint excursion occurring at push‐off. Vertical descent of the navicular (a proxy for subtalar pronation) and first metatarsophalangeal joint dorsal excursion were measured during steady locomotion over a flat substrate on a novel sample consisting of asymptomatic adult males and females, many of whom are habitually unshod. Least‐squares regression analyses indicated that, contrary to the hypothesis, navicular drop did not explain a significant amount of variation in first metatarsophalangeal joint dorsal excursion. These results suggest that, in an asymptomatic subject, the plantar aponeurosis and the associated foot bones can function effectively within the normal range of subtalar pronation that takes place during walking gait. From a clinical standpoint, this study highlights the need for investigating the in vivo kinematic relationship between subtalar pronation and metatarsophalangeal joint dorsiflexion in symptomatic populations, and also the need to explore other factors that may affect the kinematics of asymptomatic feet.     

Force assessment of the stimulated arm flexors: quantification of contractile properties

The primary objective was to develop equipment and evaluate protocols for non-invasive assessment of contractile properties of human arm flexors. The research design consisted of a non-randomized control trial, with repeated measures. Data from six males and two females were gathered in a clinical research laboratory. The elbow flexor torque following motor point or direct nerve stimulation was measured in response to single pulses or short trains of electrical pulses. Length--tension relationships were determined; comparative data were obtained at the identified optimal muscle lengths. Twitch waveforms and peak torques following either type of stimulation were reproducible (within 10%). Peak torques following a 4-pulse small interpulse interval stimulation were nearly identical for motor-point activation and direct nerve stimulation (15.2+/- 6.6Nm for motor point stimulation; 14.5 +/- 6.6Nm for nerve stimulation). Average perceived pain indexes associated with 4-pulse stimuli were slightly higher following nerve stimulation (782 for nerve versus 6.23 for motor-point, n=8). A reliable methodology (motor-point stimulation) has been identified to perform stimulated force assessment of human arm flexors.     

Microcomputer-based muscle relaxation monitor and controller for clinical use

The paper describes the design and performance of a microcomputer-based system to measure and control the level of muscle relaxation during surgical procedures. A measurement system feeds the twitch response to a train-of-four stimulation pulses into a microcomputer system. The microcomputer determines the level of muscle relaxation and then calculates, according to a specified control algorithm, the minimum amount of drug necessary to achieve adequate relaxation as rapidly as possible. The drug is administered automatically to the patient in the form of bolus injections by a motordriven syringe unit on instruction from the microcomputer. This controller system has been used in 42 clinical trials using d-tubocurarine and has proved to be capable of successfully controlling muscle relaxation.     

An intrinsically compliant robotic orthosis for treadmill training

A new intrinsically compliant robotic orthosis powered by pneumatic muscle actuators (PMA) was developed for treadmill training of neurologically impaired subjects. The robotic orthosis has hip and knee sagittal plane rotations actuated by antagonistic configuration of PMA. The orthosis has passive mechanisms to allow vertical and lateral translations of the trunk and a passive hip abduction/adduction joint. A foot lifter having a passive spring mechanism was used to ensure sufficient foot clearance during swing phase. A trajectory tracking controller was implemented to evaluate the performance of the robotic orthosis on a healthy subject. The results show that the robotic orthosis is able to perform the treadmill training task by providing sufficient torques to achieve physiological gait patterns and a realistic stepping experience. The orthosis is a new addition to the rapidly advancing field of robotic orthoses for treadmill training.