See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/41507140 Design of a programmable multi-pattern FES system for restoring foot drop in stroke rehabilitation Article in Journal of Medical Engineering & Technology · February 2010 DOI: 10.3109/03091900903580496 · Source: PubMed CITATIONS READS 10 444 3 authors: Sukanta Sabut Rocky Kumar KIIT University Indian Institute of Technology (ISM) Dhanbad 74 PUBLICATIONS 445 CITATIONS 249 PUBLICATIONS 5,415 CITATIONS SEE PROFILE SEE PROFILE Manjunatha Mahadevappa Indian Institute of Technology Kharagpur 108 PUBLICATIONS 1,893 CITATIONS SEE PROFILE Some of the authors of this publication are also working on these related projects: DWT-based Feature Extraction and Classification for Motor Imaginary EEG Signals View project Point-of-Care healthcare delivery in emerging economies View project All content following this page was uploaded by Sukanta Sabut on 04 April 2018. The user has requested enhancement of the downloaded file. Journal of Medical Engineering & Technology, Vol. 34, No. 3, April 2010, 217–223 Innovation Design of a programmable multi-pattern FES system for restoring foot drop in stroke rehabilitation S. K. SABUT*{, R. KUMAR{ AND M. MAHADEVAPPA{ {School of Medical Science & Technology, Indian Institute of Technology, Kharagpur, 721302, India {National Institute for the Orthopaedically Handicapped, Kolkata, 700090, India (Received 20 July 2009; revised 16 December 2009; accepted 23 December 2009) A programmable and portable multi-pattern transcutaneous neuromuscular stimulator was developed and evaluated for correction of foot drop in stroke subjects. The stimulator unit was designed to optimize functionality while keeping its size and power consumption to a minimum. It had two channels of biphasic stimulation (chargebalanced and constant current), and all parameters were programmable to accommodate a range of stimulation profiles. The ‘natural’ electromyographic (EMG) pattern of tibialis anterior (TA) muscle stimulation envelope algorithms and constant amplitude stimulation envelope was provided for foot drop corrections in stroke patients. A foot-switch sensor was used to trigger the device in the swing phase of gait cycle. Various tests on prototype units were performed, including output power characteristics with a skin model, and tested with a stroke subject to validate the results. This paper provides a detailed description of the hardware and block-level functional electrical stimulation (FES) system design for applications in stroke rehabilitation. Keywords: Programmable; Neuromuscular stimulator; Electromyographic; Foot drop; Stroke 1. Introduction Typically, subjects who suffer a stroke lose muscular control, affecting one side of the body, referred to as hemiplegia [1]. Foot drop is one of the pathologies in hemiplegic patients and refers to inadequate activation of the dorsiflexor muscles, due to impaired selective control and/or calf muscle spasticity [2]. The inability to properly dorsiflex the ankle results in a dragging of the foot during the swing phase and as a result has a significant impact on the person’s gait. Functional electrical stimulation (FES) is a technique which involves the use of an electrical stimulator to correct dropped foot in individuals who have a persistent upper motor neurone condition [3,4]. The concept was first proposed by Liberson in 1961, who applied a rectangular stimulation profile to the peroneal nerve to elicit a dorsiflexion of the foot synchronized with the swing phase of gait to lift the foot and prevent it from dragging on the ground during swing [5]. This stimulation profile corrected for foot drop, which obstructs the advancing limb during the swing phase of gait. Since Liberson’s study a number of implanted and surface functional electrical stimulation systems have been developed and applied successfully to restore body functions such as standing and walking [6,7]. Lyons et al. provide a detailed review of such devices [8]. Several researchers have evaluated the effect of changes to the stimulation intensity profile. The trapezoidal FES intensity envelope is most commonly used in commercial foot drop stimulators to improve the loading response *Corresponding author. Email: [email protected] Journal of Medical Engineering & Technology ISSN 0309-1902 print/ISSN 1464-522X online ª 2010 Informa UK Ltd. http://www.informaworld.com/journals DOI: 10.3109/03091900903580496 218 S. K. Sabut et al. phase of gait and to prevent the occurrence of foot-slap [9,10]. Lyons et al. [11] suggested that the trapezoidal FES envelope approach was not properly matched to the biomechanical requirements of the tibialis anterior (TA) muscle occurring during gait cycle and may lead to muscle fatigue which limits the walking of the user. Vodovnik [12] proposed adding adjustable ramp-up and ramp-down periods to the stimulation intensity envelope to avoid rapid contraction of the tibialis anterior and foot-flap due to rapid shut-off of stimulus. The work done with surface foot drop stimulators suggests that significant improvement in orthotic performance can be achieved using stimulus intensity shapes, which more closely match the TA activation pattern than the trapezoidal shape currently used [13–15]. In follow-up work, O’Keeffe et al. [16] proposed an optimized FES stimulation intensity envelope to generate the biphasic pattern of electromyographic (EMG) observed in the TA during healthy gait. A more recent application of portable neuromuscular electrical stimulation (NMES) under realtime control is for foot drop correction and blood flow assist applications [17]. The Compex Motion stimulator was used to develop various custom-made neuroprostheses for physiological studies [18]. In 1977, Stanic compared the gait of two hemiplegic subjects using a peroneal nerve stimulator (PNS) when walking with the traditional trapezoidal stimulation profile and when walking with a stimulation profile based on qualitative information provided by EMG activity of a normal person [19]. A significant improvement of the anklejoint goniograms was shown; however, no systematic analysis of the effect of different profiles was performed. Figure 1 shows the naturally occurring EMG activity which will be desirable to mimic more closely the natural pattern of the tibialis anterior muscle [20]. This study focuses on designing a low-cost, programmable neuromuscular stimulator with a stimulation profile that more closely follows natural tibialis anterior (TA) muscle activity in normal gait, and to investigate and compare with constant amplitude stimulation for foot drop correction in stroke subjects. Figure 1. Typical activity (EMG) of the tibialis anterior during a natural stride. 2. Neuromuscular stimulation system design Neuroprostheses come in many different shapes and sizes, and serve many different purposes. The three main components required for restoring motor functions after an injury of the central nervous system (such as poststroke) are the main unit (stimulator), sensor and surface electrodes. The FES system was developed to exhibit stimulus output capabilities comparable to existing neuromuscular stimulators while providing real-time stimulus adjustment and much greater flexibility in output waveform shape. The designed stimulator integrates the following functionality: (1) dual channel bipolar stimulation; (2) generation of current-controlled biphasic compensated pulses; (3) programmability of controlled pulse width, frequency and stimulation amplitude, with an easy-to-use user interface; and (4) battery supply. The power to the stimulator can be controlled by using an ON/OFF button, and a LED indicator glows when stimulator is ON. 3. FES system The FES device was designed to serve as a hardware platform for development of diverse FES systems that apply transcutaneous (surface) stimulation technology. 3.1. The portable stimulator unit A functional block diagram of the portable, dual-channel muscle stimulator unit is shown in figure 2. The stimulator consists of four functional units: (1) microcontroller, (2) power supply unit, (3) PC interface and (4) output stage. The main unit consists of a microcontroller, which generates the stimulation envelope, and a selection button for choosing different stimulation patterns and adjusting the stimulation parameters, which include frequency, amplitude, and pulse width [21]. The hardware was designed as a general platform that could be used for a wide range of possible applications. For this purpose analogue and digital input channels were implemented. Basic stimulus controls were provided for each of the two stimulation channels. Information on the operation of the device, including the treatment time and current amplitudes, is available on the display. The stimulus intensity is controlled externally via potentiometer. The unit acts as a constant current generator providing biphasic output pulses of maximum current output of 70 mA per channel. The output stage produces the desired biphasic stimulus waveforms by means of MOSFET switching circuitry. The DAC080 digital to analogue converter (DAC) was used to convert the programmed digital values into analogue values corresponding to the output channel. The DAC0808 is an 8-bit monolithic DAC featuring a full scale output current settling time of 150 ns while dissipating only 33 mW with +5 V supplies. The power supply current of the A programmable FES system for stroke rehabilitation 219 Figure 2. Block diagram of the portable FES system. DAC0808 is independent of bit codes, and exhibits essentially constant device characteristics over the entire supply voltage range. Special attention was paid to the design of the DC/DC converter, which mostly determines the overall efficiency of the device. A modified push-pull step-up switching converter topology was adopted as the optimal solution. A foot switch sensor was incorporated in the hardware design to make the stimulator ON during the swing phase and OFF during the stance phase of walking gait, which is usually around 60% of the gait cycle. This ON/OFF pattern of stimulation helps to minimize muscle fatigue by giving time for the target muscle to rest, and extends the battery life. A 9 V rechargeable battery provides the main power for the unit, to improve safety. Power-saving features were incorporated in the system design to minimize power consumption by using Complementary metal-oxide-semiconductor (CMOS) components wherever possible. A patient-controlled cut-off button was designed in the hardware for an emergency stop. 3.2. Microcontroller The microcontroller is the main part of the stimulator used for generating ‘natural’ TA muscle and periodic rectangular pulse stimulation patterns at the desired frequency and pulse width. It controls all of the stimulator’s functional units (e.g. pulse generator, power supply unit and user interface); hence many electronic components were removed from the design to reduce size and weight of the device. After analysing the requirements for this stimulator, 220 S. K. Sabut et al. frequency (10–50 Hz) and pulse voltage (0–120 V). In general, the amplitude of a surface stimulation ranges from 10 to 90 mA. 4. Generated pulses Initially two algorithms were available for foot drop and other applications such as hand function, shoulder subluxation and knee extension. Single or dual channel stimulation with sensor feedback provided from the affected leg is available for both of these algorithms. The clinician can select a natural TA EMG envelope or rectangular pulse patterns for treatments. 4.1. Foot drop stimulation Figure 3. ‘Natural’ TA EMG envelope foot drop algorithm. we chose AT89C2051 (KeilTM, an ARM1 Company) chip, which is a low-voltage, high-performance CMOS 8-bit microcontroller and allows changes to the program code to be easily implemented. It provides a highly flexible and cost-effective solution to many embedded control applications and is suitable for battery operated devices. This microcontroller unit fulfils all requirements for newly designed devices. 3.3. Power supply unit The stimulator block provides two channels of stimulus and contains a power conversion block which converts the battery’s 9-V output to 5 V. The high voltage circuit includes a step-up DC/DC converter to convert the 5 V supply into the high voltage range (0–150 V) required for stimulation in various clinical applications. Battery supplied devices are intrinsically safe and they also provide greater mobility. A patient-controlled cut-off button was used for an emergency stop for when painful shock happens. 3.4. Stimulus waveform Motor neurons can be stimulated by both monophasic and biphasic currents or by voltage pulses. It is generally believed that the injected charge should not be allowed to accumulate over time as these electric charges depolarize the membrane of the motor neuron, which causes the generation of an action potential. Therefore, most FES systems implement biphasic current pulses or charge balanced waveforms, allowing the amount of the charge to depolarize the motor neuron and then to balance the charge. The stimulus parameters delivered by the stimulator were within the ranges used by existing muscle stimulator devices: pulse width (100–500 ms), pulse A ‘natural’ envelope stimulation strategy was proposed based on muscle activation patterns observed in healthy gait [20]. The generated stimulation waveform was close to the natural EMG pattern of tibialis anterior muscle with a pulse width of 250–500 ms and a stimulation frequency of 40 Hz, and applied to the driver circuit. A single cycle of the stimulus output of 1.3 s for this algorithm, which was adjustable (figure 3), was captured by the digital storage oscilloscope (DSO). This natural stimulation envelope provides tetanized muscle contraction for functional movements and reduces the charge delivered, which is a very important for better functional performance with reduced muscle fatigue and lower power consumption in the electronic stimulator. This specialized stimulation envelope could be used for the correction of foot drop in stroke and other upper motor neuron lesions (UMNs). A foot switch sensor control was used to control the triggering of the stimulator; the system is ON during swing phase and OFF during stance phase of the gait cycle. 4.2. Constant amplitude rectangular pulse The generated stimulation pulse trains were packets of rectangular pulses of constant current having pulse width of 300 ms and frequency 40 Hz, which do not appear continuously at the output, but rather in packets of bursts with a duration of 4 s ON and 1 s OFF between successive bursts, as shown in figure 4. This waveform pattern can initially be used in foot drop to ensure a proper electrode placement and for muscle conditioning. 5. System test results To date the designed stimulator has been bench tested and tested with healthy subjects; clinical evaluation is to follow. This study received prior ethical approval from the Institute Ethical Committee (IEC) and the test subjects gave informed written consent prior to testing. Preliminary testing of the system on subjects was promising. Further 221 A programmable FES system for stroke rehabilitation testing will be carried out on a higher number of patients with foot drop pathology at the clinical trial period at the National Rehabilitation Institution. The operating specifications of the designed neurostimulator are summarized in table 1. These electrical stimulation parameters provide tetanized muscle contraction as required for functional movements, and reduce the rate of fatigue within the clinically established safety limits [17]. 5.1. Testing with skin model It was important that the stimulator should accurately reproduce the programmed stimulation intensity parameters. The appropriate stimulus tests were performed using a 1 kO resistor in parallel with a 100 nF capacitive load. This was the same arrangement as used by Odstock Medical Limited, Salisbury, UK, makers of the Odstock Drop Foot Stimulator (ODFS). It was a simplified circuit equivalent of the skin model and also tested with study volunteers. The output waveforms were measured for both tests using a Scientific SM2100 digital oscilloscope. The accuracy of the programmable parameters for the stimulation intensity envelope was tested using a natural TA muscle envelope and rectangular pulses. The results of the test with a 1 kO resistor in parallel with a 100 nF capacitive load are listed in table 2. It was found that the performance of the muscle stimulator matched the design conditions. As can be seen from table 2, the stimulus output values are accurate to within +3% of the programmed values, which satisfies the general system requirement for accuracy. Similarly stimulus tests were performed using a 470 O resistor in parallel with a 100 nF capacitive load listed (table 3). The maximum current amplitude of 72 mA, considering a load resistance of 1 kO, was associated with the maximum peak current. Moreover the lower percentage error in both amplitude voltage and in the pulse width occurs for the smaller load resistance (470 O). 5.2. Testing with subjects The system was tested with a stroke subject walking with the device for a 15–30-min treatment session per day over the course of 4 weeks, and compared with the constant amplitude rectangular stimulation pattern. The stimulation was applied through skin-surface electrodes on the leg by stimulating the common peroneal nerve and motor point of the tibialis anterior muscle to produce muscle contractions that mimic normal voluntary actions, lifting the foot off the ground and improving gait during the swing phase. The devices employed a heel switch to determine when the affected limb comes into contact with the ground. When Table 2. Stimulation intensity envelope test results. Parameters Pulse-width (ms) Pulse-interval (ms) Frequency (Hz) Output voltage (assuming a 1 kO load) Range (assuming a 1 kO load) Voltage (V) Amplitude (mA) Figure 4. Packets of rectangular waves. Features Number of channels Output mode Current output Output voltage range Pulse width Stimulation frequency Battery Characteristics Two Biphasic, constant-current stimulation 0–72 mA 0–120 V 300–700 ms 10–50 Hz Rechargeable 9 V Measured Percentage Error (%) 680 27.2 36.8 41 700 27.4 36.5 30 2.9 0.7 0.8 26.8 – – 0–72 0–72 – – Table 3. Stimulation intensity envelope test results. Parameters Table 1. Specification of the stimulator. Programmed Pulse-width (ms) Pulse-interval (ms) Frequency (Hz) Output voltage (V) (assuming a 470O load) Range (assuming a 470O load) Voltage (V) Amplitude (mA) Programmed Measured Percentage Error (%) 680 27.2 36.8 41 680 27.4 36.5 34 0 0.7 0.8 17 – – 0–38 0–80 – – 222 S. K. Sabut et al. Table 4. Temporal gait parameters and RMS values obtained from hemiplegic patients. ‘Natural TA’ pattern Parameters 71 Speed (m s ) Cadence (steps min71) Step length (cm) PCI (beats m71) Range of motion of ankle joint (active) (8) TA muscle RMS (mV) Mean (mV) Rectangular pattern Pre-test Post-test % change Pre-test Post-test % change 0.55 67 47 0.18 25 0.7 85 49 0.12 30 27.2 26.8 4.2 33.3 20 0.51 71 43 0.19 20 0.62 86 44 0.16 25 21.5 21.1 2.3 15.7 25 0.12 0.04 50 48.1 0.11 0.03 37.5 11.1 0.08 0.027 there is weight on the heel, the device is off. When weight is off the heel, the device turns on, causing the ankle to dorsiflex. At the completion of the 4-week trial, the subject was re-evaluated for gait parameters, range of motion and root mean square (RMS) value of EMG of tibialis anterior muscle. Table 4 shows the compared result between subjects tested with natural TA muscle pulse pattern and constant rectangular pulse amplitude. The tested result shown the walking speed increased from 0.55 ms71 to 0.7 ms71 by 27.27% with natural TA pattern and 0.51 ms71 to 0.62 ms71 by 21.5% with constant amplitude pattern. The RMS value of TA muscle has shown improvement by 50% with the natural pattern and 37.5% with the constant amplitude pattern. Similarly, other parameters of walking gait and electromyographic activity (table 4) showed better improvement with natural TA pattern stimulus compared to the constant amplitude rectangular stimulus pattern. The result indicates better improvement in gait ability and strengthening muscle power with natural TA pattern. The observed walking gait reveals ankle angle trajectory closer to the normal trajectory and an improved loading response phase, where audible foot slap was prevented and maximal plantarflexion decreased. 5.3. Determination of strength–duration curve We conducted an experiment to determine chronaxie/ rheobase values by plotting the strength–duration (S–D) curves of dorsiflexor muscle. First, the rheobase was determined at a rectangular pulse of 50 ms duration with a stimulation frequency of 40 Hz. The S–D curve was determined by decreasing the widths of impulses (400, 350, 300, 250, 200, 150, 100 and 50 ms), while observing a minimal visible contraction of the muscle at that particular amplitude (mA) of the stimulus. As the duration of a test stimulus is increased, the strength of the current required to just reach the stimulation threshold decreases. The S–D characteristics of the tested subjects are shown in figure 5, revealing that the intensity of stimulation current decreases with increase in pulse duration for activation of muscles. 0.08 0.027 Figure 5. Average strength–duration curve (mean + SD) (n ¼ 6). The average normal chronaxie value of an innervated muscle is 300 ms, after which the curve becomes saturated. 6. Discussion and conclusions This paper describes the design, validation and evaluation of a dual-channel microcontroller-based FES system intended for a wide variety of clinical research settings by replacing many of the analogue circuits. We incorporated a ‘natural’ tibialis anterior EMG muscle stimulus pattern that could be used for clinical application in foot drop correction, and a rectangular pattern used for common therapeutic applications such as foot drop, hand functions and shoulder subluxation in stroke and other neurological disorders. The device was portable, affordable and user friendly so that patients can carry their own FES systems to be used at home in activities of daily living instead of visiting hospitals regularly. Bench test evaluation showed that the device worked satisfactorily according to designed specifications and the efficiency of the natural stimulation pattern was demonstrated in foot drop correction with a hemiparetic patient. The TA muscle was stimulated and an improvement of walking ability, and ankle joint range of motion (ROM) and strengthened muscle power were observed compared to the constant amplitude stimulus A programmable FES system for stroke rehabilitation pattern. The natural EMG pattern of the stimulus was promising in foot drop correction with normal trajectory ankle motion that mimics the natural gait pattern while walking. These findings suggest that further investigation should be carried out on larger numbers of stroke subjects with foot drop, and also that a comparison should be made with the conventional trapezoidal stimulation pattern. 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