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.     

A microcontroller system for investigating the catch effect: functional electrical stimulation of the common peroneal nerve

Correction of drop foot in hemiplegic gait is achieved by electrical stimulation of the common peroneal nerve with a series of pulses at a fixed frequency. However, during normal gait, the electromyographic signals from the tibialis anterior muscle indicate that muscle force is not constant but varies during the swing phase. The application of double pulses for the correction of drop foot may enhance the gait by generating greater torque at the ankle and thereby increase the efficiency of the stimulation with reduced fatigue. A flexible controller has been designed around the Odstock Drop Foot Stimulator to deliver different profiles of pulses implementing doublets and optimum series. A peripheral interface controller (PIC) microcontroller with some external circuits has been designed and tested to accommodate six profiles. Preliminary results of the measurements from a normal subject seated in a multi-moment chair (an isometric torque measurement device) indicate that profiles containing doublets and optimum spaced pulses look favourable for clinical use.     

A novel motion sensor-driven control system for FES-assisted walking after spinal cord injury: A pilot study

This pilot study reports the development of a novel closed-loop (CL) FES-gait control system, which employed a finite-state controller that processed kinematic feedback from four miniaturized motion sensors. This strategy automated the control of knee extension via quadriceps and gluteus stimulation during the stance phase of gait on the supporting leg, and managed the stimulation delivered to the common peroneal nerve (CPN) during swing-phase on the contra-lateral limb. The control system was assessed against a traditional open-loop (OL) system on two sensorimotor ‘complete’ paraplegic subjects. A biomechanical analysis revealed that the closed-loop control of leg swing was efficient, but without major advantages compared to OL. CL automated the control of knee extension during the stance phase of gait and for this reason was the method of preference by the subjects. For the first time, a feedback control system with a simplified configuration of four miniaturized sensors allowed the addition of instruments to collect the data of multiple physiological and biomechanical variables during FES-evoked gait. In this pilot study of two sensorimotor complete paraplegic individuals, CL ameliorated certain drawbacks of current OL systems – it required less user intervention and accounted for the inter-subject differences in their stimulation requirements.     

Wavelet based analysis and characterization of the ECG signal

We present details of the modelling, design, and experimental testing of an implantable system with a monopolar half-cuff electrode for selective stimulation of fibres within certain superficial regions of the human common peroneal nerve which is capable of making a selective activation of muscles, thus contributing to strong dorsal flexion and moderate eversion of the hemiplegic foot. The development of the cuff electrode was based partly on data obtained from histological examination of human common peroneal nerves, and from previously described models of excitation of myelinated nerve fibres. The modelling objectives were to determine the electric field that would be generated within the deep peroneal branch of the nerve by a monopolar half-cuff electrode installed on the nerve behind the lateral head of the fibula. The extent of initial excitation of the nerve fibres within the superficial region of the deep peroneal branch elicited by a monopolar half-cuff electrode was predicted. In the past 6 months two systems were implanted. In both patients significant improvements of gait dynamics were observed.     

Cutaneous mechanisms of isometric ankle force control

The sense of force is critical in the control of movement and posture. Multiple factors influence our perception of exerted force, including inputs from cutaneous afferents, muscle afferents and central commands. Here, we studied the influence of cutaneous feedback on the control of ankle force output. We used repetitive electrical stimulation of the superficial peroneal (foot dorsum) and medial plantar nerves (foot sole) to disrupt cutaneous afferent input in 8 healthy subjects. We measured the effects of repetitive nerve stimulation on (1) tactile thresholds, (2) performance in an ankle force-matching and (3) an ankle position-matching task. Additional force-matching experiments were done to compare the effects of transient versus continuous stimulation in 6 subjects and to determine the effects of foot anesthesia using lidocaine in another 6 subjects. The results showed that stimulation decreased cutaneous sensory function as evidenced by increased touch threshold. Absolute dorsiflexion force error increased without visual feedback during peroneal nerve stimulation. This was not a general effect of stimulation because force error did not increase during plantar nerve stimulation. The effects of transient stimulation on force error were greater when compared to continuous stimulation and lidocaine injection. Position-matching performance was unaffected by peroneal nerve or plantar nerve stimulation. Our results show that cutaneous feedback plays a role in the control of force output at the ankle joint. Understanding how the nervous system normally uses cutaneous feedback in motor control will help us identify which functional aspects are impaired in aging and neurological diseases.     

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.     

Aging of human segmental oligosynaptic reflexes for control of leg movement

A heteronymous group I oligosynaptic reflex from the common peroneal nerve to vastus medialis muscle was compared with a group I homonymous monosynaptic reflex to soleus, using electrical stimulation of peripheral nerve trunks in two groups of healthy men, mean ages 22 and 65 years. The oligosynaptic reflex was still elicitable with age, its magnitude decreasing similarly to the monosynaptic reflex. A further group of older subjects, mean age 75 years, showed similar results. Clearly, the oligosynaptic reflex is not lost with healthy aging. The motor interneuronal pool may at least partially avoid the age-related cell loss of motoneuronal pools, with consequent maintenance of segmental participation for movements such as gait. The slowing of conduction velocities, for these proprioceptive reflex arcs, may reduce the effectiveness of autoregulation of the gait.     

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.     

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.     

A review of the design and clinical evaluation of the ShefStim array-based functional electrical stimulation system

Functional electrical stimulation has been shown to be a safe and effective means of correcting foot drop of central neurological origin. Current surface-based devices typically consist of a single channel stimulator, a sensor for determining gait phase and a cuff, within which is housed the anode and cathode. The cuff-mounted electrode design reduces the likelihood of large errors in electrode placement, but the user is still fully responsible for selecting the correct stimulation level each time the system is donned. Researchers have investigated different approaches to automating aspects of setup and/or use, including recent promising work based on iterative learning techniques. This paper reports on the design and clinical evaluation of an electrode array-based FES system for the correction of drop foot, ShefStim. The paper reviews the design process from proof of concept lab-based study, through modelling of the array geometry and interface layer to array search algorithm development. Finally, the paper summarises two clinical studies involving patients with drop foot. The results suggest that the ShefStim system with automated setup produces results which are comparable with clinician setup of conventional systems. Further, the final study demonstrated that patients can use the system without clinical supervision. When used unsupervised, setup time was 14 min (9 min for automated search plus 5 min for donning the equipment), although this figure could be reduced significantly with relatively minor changes to the design.     

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.     

Effects of a task failure exercise on the peroneus longus and brevis during perturbed gait

Ankle inversion injuries represent the most common trauma sustained by athletes. Muscle fatigue from activity may contribute to a delay in the response of the ankle proprioceptors and dynamic restraints during unexpected inversion. The purpose of this investigation was to determine changes in peroneal average EMG, peak EMG, and time to peak EMG following a task failure exercise. Thirty-two subjects (age 20+/-1.43 yrs; 21 male, 11 female) with no lower extremity injuries reported for data collection. Data were collected from each subject's dominant leg using surface electromyography (EMG). EMG electrodes were applied over the peroneus longus (PL) and brevis (PB) using a standard protocol Subjects walked at a fixed pace on a 6.1 m runway with one section that could be unexpectedly dropped into 30 degrees of inversion upon foot contact. Trials with perturbed and unperturbed gait were randomized to reduce prediction of the unexpected inversion. Once 3 trials of perturbed gait were recorded, subjects completed an isotonic activity that isolated the peroneals. The task was completed to failure. Immediately following the task failure exercise, subjects walked on the perturbation runway once again until 3 trials of perturbed gait were recorded. Analysis revealed no significant differences with regard to average muscle activity between pre- and post-task failure exercise for the PL (F1,31 = 0.133; p = 0.718) or for the PB (F1,31 = 0.795; p = 0.380). There was also no significant difference in peak muscle activity pre- to post-task failure for the PL (F1,31 = 0.032; p = 0.859) or the PB (F1,31 = 0.156; p = 0.695). Finally, there was no significant difference in time-to-peak muscle activity pre- to post-task failure for the PL (F1,31 = 0.830; p = 0.369) or the PB (F1,31 = 1.037; p = 0.316). We concluded that the task failure exercise did not contribute to changes in peroneal activity during perturbed gait. These results indicate that peroneal fatigue does not play a significant role in the incidence of inversion ankle sprains.     

Adaptation of cutaneous stumble correction when tripping is part of the locomotor environment

We recently showed that cutaneous reflexes evoked by stimulating the superficial peroneal (SP; innervates foot dorsum) nerve are modulated according to the level of postural threat. Context-related modulation was observed mainly in contralateral (c) responses but not in the ipsilateral responses. This lack of effect on ipsilateral (i) cutaneous reflexes might have been caused by the general nature of the whole body perturbation. We therefore hypothesized that context-relevant mechanical perturbations applied to the dorsum of the foot by an instrumented rod at early swing during walking would produce differences in ipsilateral cutaneous reflex amplitudes, consistent with the functional relevance of the SP nerve in stumble correction responses. Subjects walked on a motorized treadmill under four conditions: 1) normal, 2) normal with mechanical perturbations at the foot dorsum, 3) arms crossed, and 4) arms crossed with mechanical perturbations at the foot dorsum. Electrical stimulation of the SP nerve was delivered at five phases of the step cycle, and cutaneous reflexes were compared between all conditions for each phase of the step cycle. Reflex responses were generally found to be modulated in amplitude during walking conditions in which mechanical perturbations were delivered, particularly in ipsilateral tibialis anterior (iTA), which showed a marked reduction in inhibition. The results indicated cutaneous reflexes in iTA and contralateral medial gastrocnemius (cMG) were influenced by the threat of a trip, induced by applying mechanical perturbations to the foot dorsum during walking. This task-related gating of cutaneous reflexes was not generalized to all muscles, thus suggesting a functional role in the maintenance of stability during locomotion.     

Grip force control during gait initiation with a hand-held object

When walking with a hand-held object, grip force is coupled in an anticipatory manner to changes in inertial force resulting from the accelerations and decelerations of gait. However, it is not known how grip and inertial forces are organized at the onset of gait, and if the two forces are coupled in the early phases of gait initiation. Moreover, initiating walking with an object involves the coordination of anticipatory postural (e.g., ground reaction force changes) and grasping adjustments. The aim of this study was to investigate the relationship of ground reaction, grip, and inertial force onsets, and the subsequent development of the coupling of grip and inertial forces during gait initiation with a hand-held object. Ten subjects performed gait initiation with a hand-held object following predictable and unpredictable start signals. We found that ground reaction and grip force onsets were closely linked in time regardless of the predictability of the start signal. In the early period of gait initiation, the grip force started to increase prior to inertial force changes. While the strength of the coupling of grip and inertial forces was moderate in this early phase, it increased to values observed during steady-state gait after the swing foot left the ground. The early grip force increase and the coupling of grip and inertial forces represent an anticipatory control process. This process establishes an appropriate grip-inertial force ratio to ensure object stability during acceleration after foot-off and maintains this increased ratio thereafter. The results suggest that grasping and whole body movements are governed by a common internal representation.     

Size and separability of the calcaneal and the medial and lateral plantar nerves in the distal tibial nerve

The tibial nerve (TN) has three main terminal branches: the medial and lateral plantar nerves and the calcaneal branch (CB), which innervates the foot sole. The design and implantation of nerve cuff electrodes with separate channels for each of these three terminal branches would provide significant sensory information, which can be used in functional electrical stimulation systems to assist standing or to correct foot drop. Detailed quantitative anatomical data about fascicular size and separability of the terminal branches of TN are needed for the design and implantation of such cuff electrodes. Therefore, the branching pattern, the fascicular separability and the fascicular size of the TN posterior to the medial malleolar-calcaneal axis were examined in this study, using ten human TN specimens. The TN branching patterns were highly dispersed. For the CBs, multiple branches were identified in five (50%) of the specimens. For the TN, the bifurcation point was located within the tarsal tunnel in eight (80%) of the cases. The distance proximal to the medial malleolar-calcaneal axis for which the TN could be split ranged form 0 to 41 mm. Quantitative and qualitative data were obtained for the fascicular size and separability of the TN. Only the CB of the TN proved separable for a sufficient length for nerve cuff electrode implantation. The results suggest the use of a two-channel cuff with one common channel for the lateral and medial plantar nerves, having multiple electrodes for selective recording, and one channel for the CB.     

Supraspinal control over segmental centers of antagonist muscles in man. III. Tuning of spinal reciprocal inhibition system during organization preceding voluntary movement

Conditioning stimulation of the peroneal nerve at rest produces a decrease in the N-response of the antagonist (soleus) muscle. The short latency of this inhibitory effect (not more than 2 msec) indicates that it is produced by the spinal reciprocal inhibition system (SRIS). Paired stimulation with a fixed delay of 3 msec between conditioning stimulation of the peroneal nerve and testing stimulation of the tibial nerve indicates that during the last 30 msec before voluntary movement (rapid dorsiflexion of the foot) reciprocal inhibition of the motoneuronal nucleus of the soleus muscle, the antagonist of the voluntary movement, is strengthened. During organization of the voluntary movement there is supraspinal facilitation (tuning) of the SRIS. Supraspinal regulation of the SRIS is one of the mechanisms of central control over the segmental centers of antagonist muscles.     

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

     

The development of a closed-loop controlled functional electrical stimulation (FES) in gait training.

A closed-loop functional electrical stimulation (FES) system is developed to provide hemiplegic patients with a real-time stimulation to their muscles to prevent the drop-foot and the quadriceps weakness from happening during gait training. The FES is controlled by position sensors (ps) and triggered by footswitches (f) with real-time feedback. As the FES receives the signals from these sensors, it adjusts and outputs an optimum set of stimulation parameters automatically. One hemiplegic patient was recruited to conduct clinical evaluation and treated by using the new closed-loop FES system. It was revealed that the mean velocity, cadence, stride length, active ankle motion range, and functional ambulation category (FAC) improved significantly from 0.12 +/- 0.07 ms-1, 40.3 +/- 18.3 steps min-1, 0.35 +/- 0.10 m, 15 degrees, level 2 to 0.42 +/- 0.23 ms-1, 68.2 +/- 19.0 steps min-1, 0.70 +/- 0.22 m, 40 degrees, level 4 respectively for the patient. A paired t-test indicated that differences in the electromyography (EMG) of the tibialis anterior and the quadriceps muscles between the patient's disabled (affected side) foot and normal (unaffected side) foot are not significant (p > 0.05) after 12 weeks of training. It is concluded that this new closed-loop FES system is capable of providing this hemiplegic patient with restoration to regular walking after appropriate gait training. Future studies, including randomized-controlled study, should be implemented to document the efficacy of this system.     

Human interlimb reflexes evoked by electrical stimulation of cutaneous nerves innervating the hand and foot

There is some discrepancy over the extent to which reflex pathways from different cutaneous nerves in the hand and foot link the cervical and lumbar spinal cord in neurologically intact humans. The present experiments were designed to determine whether stimulation of a cutaneous nerve in the foot or in the hand evoked reflexes in the non-stimulated limbs (interlimb reflexes). Reflexes were elicited by stimulating (5x1-ms pulses at 300 Hz) the superficial peroneal (SP; innervates the foot dorsum) or superficial radial (SR; innervates the dorsolateral portion of the hand) nerve while subjects (n=10) performed focused contractions of different upper and lower limb muscles. Reflex responses were divided into early (<75 ms), middle (75-120 ms), and late (>120 ms) epochs as determined from averages of 50 sweeps of stimulus-locked electromyographic activity. Significant interlimb reflexes were found at the early latency in 44/106 and 44/103 muscles sampled after SP and SR nerve stimulation, respectively. At the middle latency, significant interlimb reflexes were seen in 89/106 and 87/103 muscles sampled after SP and SR nerve stimulation, respectively. Interlimb reflexes were seen when stimulating at the wrist (i.e. SR nerve) and when stimulating at the ankle (i.e. SP nerve) with an equal probability. The results show that interlimb cutaneous reflexes are widely distributed in humans. The mean latency of the earliest response was quite short and may be mediated by a propriospinal pathway. Functionally, these pathways may provide a substrate for transferring information to coordinate movements between the limb segments.