A SELF-OPTIMISING PORTABLE FES SYSTEM USING AN ELECTRODE ARRAY AND MOVEMENT SENSORS

A portable functional electrical stimulation system has been designed using embedded systems technology. The system, which was applied to patients suffering from foot drop, uses sensors to monitor foot movement and orientation in a unique way, uses sophisticated algorithms for feedback, and drives an array of surface electrodes for stimulation. This system meets British Standards and safety requirements for medical equipment. A new technique was invented based on using the twitch response of muscles to optimise the configuration of the electrode array. This reduces the setup time in the clinic. Using feedback from the sensors, the optimum configuration of electrodes is chosen to produce correct stimulation and movement in real time. The instrument presents the patient with a ranked list of electrode combinations that are likely to be optimum; the patient can then choose a combination that is both effective and comfortable. The system is also able to vary the chosen pattern of electrodes and the stimulation signal parameters during the stimulation process. This may enable some problems associated with fatigue and skin irritation to be reduced. Trials were carried on 30 controls and 12 patients to test the instrument and study and develop the system optimisation and control algorithms. These preliminary clinical trials showed that control of the stimulation during walking, based on the optimisation algorithms developed in this work, gives high quality correction of foot drop. This was shown by gait assessment analysis by the physiotherapists involved in the project and blind assessment using independent researchers. These trials prove that the concept of using the electrode array for stimulation has advantages over using a conventional 2-electrode system.

[1]  M. J. Campbell,et al.  Neuromuscular parameters in multiple sclerosis patients - significance for programmes of neuromuscular stimulation , 1993 .

[2]  Robert P Patterson,et al.  The Current Reguirements And The Pain Response For Various Sizes Of Surface Stimulation Electrodes , 1991, Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society Volume 13: 1991.

[3]  P. Veltink,et al.  Estimating orientation with gyroscopes and accelerometers. , 1999, Technology and health care : official journal of the European Society for Engineering and Medicine.

[4]  L. Baker,et al.  Effects of waveform parameters on comfort during transcutaneous neuromuscular electrical stimulation , 2006, Annals of Biomedical Engineering.

[5]  Richard W. Bohannon,et al.  Interrater reliability of a modified Ashworth scale of muscle spasticity. , 1987, Physical therapy.

[6]  M H Granat,et al.  Evaluation of patterned stimulation for use in surface functional electrical stimulation systems. , 1998, Medical engineering & physics.

[7]  W. Mayr,et al.  Long‐Term Results of Nervous Tissue Alterations Caused by Epineurial Electrode Application: An Experimental Study in Rat Sciatic Nerve , 1992, Pacing and clinical electrophysiology : PACE.

[8]  Thomas Sinkjær,et al.  Cutaneous whole nerve recordings used for correction of footdrop in hemiplegic man , 1995 .

[9]  J Nilsson,et al.  Stimulus artifact compensation using biphasic stimulation , 1988, Muscle & nerve.

[10]  P. Veltink,et al.  The Sensitivity and Selectivity of an Implantable Two‐Channel Peroneal Nerve Stimulator System for Restoration of Dropped Foot , 2002, Neuromodulation : journal of the International Neuromodulation Society.

[11]  T. Sinkjaer,et al.  A review of portable FES-based neural orthoses for the correction of drop foot , 2002, IEEE Transactions on Neural Systems and Rehabilitation Engineering.

[12]  F.E. Zajac,et al.  Paraplegic standing controlled by functional neuromuscular stimulation. I. Computer model and control-system design , 1989, IEEE Transactions on Biomedical Engineering.

[13]  J J Abbas,et al.  New control strategies for neuroprosthetic systems. , 1996, Journal of rehabilitation research and development.

[14]  D N Rushton,et al.  Functional electrical stimulation , 1997, Physiological measurement.

[15]  P. Fromherz,et al.  Noninvasive neuroelectronic interfacing with synaptically connected snail neurons immobilized on a semiconductor chip , 2001, Proceedings of the National Academy of Sciences of the United States of America.

[16]  R Williamson,et al.  Gait event detection for FES using accelerometers and supervised machine learning. , 2000, IEEE transactions on rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society.

[17]  William F. Agnew,et al.  Histologic and physiologic evaluation of electrically stimulated peripheral nerve: Considerations for the selection of parameters , 2006, Annals of Biomedical Engineering.

[18]  Daniel Graupe,et al.  Neural network control of neuromuscular stimulation in paraplegics for independent ambulation , 1997, Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. 'Magnificent Milestones and Emerging Opportunities in Medical Engineering' (Cat. No.97CH36136).

[19]  L. L. Howard,et al.  Description and demonstration of a CMOS amplifier-based-system with measurement and stimulation capability for bioelectrical signal transduction. , 1998, Biosensors & bioelectronics.

[20]  J. Hoffer,et al.  Gait phase information provided by sensory nerve activity during walking: applicability as state controller feedback for FES , 1999, IEEE Transactions on Biomedical Engineering.

[21]  B. Andrews,et al.  Improving limb flexion in FES gait using the flexion withdrawal response for the spinal cord injured person. , 1993, Journal of biomedical engineering.

[22]  Gad Alon,et al.  High Voltage Stimulation , 1985 .

[23]  J. Albers,et al.  Single motor unit and fiber action potentials during fatigue. , 1985, Journal of applied physiology.

[24]  D.R. McNeal,et al.  A four-channel IBM PC/AT compatible biphasic pulse generator for nerve stimulation , 1989, IEEE Transactions on Biomedical Engineering.

[25]  N. Hoshimiya,et al.  A multichannel FES system for the restoration of motor functions in high spinal cord injury patients: a respiration-controlled system for multijoint upper extremity , 1989, IEEE Transactions on Biomedical Engineering.

[26]  R. Kobetic,et al.  Tetanic responses of electrically stimulated paralyzed muscle at varying interpulse intervals , 1989, IEEE Transactions on Biomedical Engineering.

[27]  D. Mcneal,et al.  Effects of joint angle, electrodes and waveform on electrical stimulation of the quadriceps and hamstrings , 2006, Annals of Biomedical Engineering.

[28]  A M Boonstra,et al.  The effect of low-frequency electrical stimulation on denervation atrophy in man. , 1987, Scandinavian journal of rehabilitation medicine.

[29]  D. M. Wilson,et al.  The catch property of ordinary muscle. , 1968, Proceedings of the National Academy of Sciences of the United States of America.

[30]  R. Aćimović,et al.  Effect of gradually modulated electrical stimulation on the plasticity of artificially evoked movements , 2006, Medical and Biological Engineering and Computing.

[31]  F. Rattay,et al.  Modeling the excitation of fibers under surface electrodes , 1988, IEEE Transactions on Biomedical Engineering.

[32]  T. Sinkjaer,et al.  Natural versus artificial sensors applied in peroneal nerve stimulation. , 1997, Artificial organs.

[33]  D. McCreery,et al.  Damage in peripheral nerve from continuous electrical stimulation: Comparison of two stimulus waveforms , 2006, Medical and Biological Engineering and Computing.

[34]  J V Basmajian,et al.  Biofeedback treatment of foot drop after stroke compared with standard rehabilitation technique (part 2): effects on nerve conduction velocity and spasticity. , 1976, Archives of physical medicine and rehabilitation.

[35]  D. Wade,et al.  Walking after stroke. Measurement and recovery over the first 3 months. , 2020, Scandinavian journal of rehabilitation medicine.

[36]  Leonard K. Kaczmarek,et al.  The Neuron: Cell and Molecular Biology , 1991 .

[37]  A. Trnkoczy,et al.  Optimal stimulus parameters for minimum pain in the chronic stimulation of innervated muscle. , 1975, Archives of physical medicine and rehabilitation.

[38]  J P Paul,et al.  Biomechanics of functional electrical stimulation , 1982, Prosthetics and orthotics international.

[39]  P H Veltink,et al.  Three dimensional inertial sensing of foot movements for automatic tuning of a two-channel implantable drop-foot stimulator. , 2003, Medical engineering & physics.

[40]  M. Kljajić,et al.  Gait evaluation in hemiparetic patients using subcutaneous peroneal electrical stimulation. , 1992, Scandinavian journal of rehabilitation medicine.

[41]  J. Kawamura,et al.  Functional neuromuscular stimulation system using an implantable hydroxyapatite connector and a microprocessor-based portable stimulator , 1989, IEEE Transactions on Biomedical Engineering.

[42]  M H Granat,et al.  A practical gait analysis system using gyroscopes. , 1999, Medical engineering & physics.

[43]  Michael R. Neuman,et al.  Sensors for Use with Functional Neuromuscular Stimulation , 1986, IEEE Transactions on Biomedical Engineering.

[44]  Brian Reed The Physiology of Neuromuscular Electrical Stimulation , 1997 .

[45]  J. Patrick,et al.  Computer-controlled 22-channel stimulator for limb movement. , 1987, Acta neurochirurgica. Supplementum.

[46]  Y. Jimbo,et al.  Electrical stimulation and recording from cultured neurons using a planar electrode array , 1992 .

[47]  B. G. Celler,et al.  Classification of basic daily movements using a triaxial accelerometer , 2004, Medical and Biological Engineering and Computing.

[48]  J. Basmajian,et al.  Peroneal nerve stimulator in rehabilitation of hemiplegic patients. , 1975, Archives of physical medicine and rehabilitation.

[49]  P H Veltink,et al.  Detection of static and dynamic activities using uniaxial accelerometers. , 1996, IEEE transactions on rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society.

[50]  C. A. Kirkwood,et al.  Automatic detection of gait events: a case study using inductive learning techniques. , 1989, Journal of biomedical engineering.

[51]  W. G. S. Stephens,et al.  The current-voltage relationship in human skin , 1963, Medical electronics and biological engineering.

[52]  M. Whittle Gait analysis: an introduction - 3rd edition , 2003 .

[53]  S Naumann,et al.  Stretch reflex inhibition using electrical stimulation in normal subjects and subjects with spasticity. , 1991, Journal of biomedical engineering.

[54]  Dejan B. Popovic,et al.  "Actitrode®": a new surface electrode-array for selective electrical stimulation , 2004 .

[55]  Yasuhiko Jimbo,et al.  A system for MEA-based multisite stimulation , 2003, IEEE Transactions on Biomedical Engineering.

[56]  R B Stein,et al.  Application of tilt sensors in functional electrical stimulation. , 1996, IEEE transactions on rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society.

[57]  David A. Winter,et al.  Biomechanics and Motor Control of Human Movement , 1990 .

[58]  P. E. K. Donaldson,et al.  When are actively balanced biphasic (‘Lilly’) stimulating pulses necessary in a neurological prosthesis? I Historical background; Pt resting potential;Q studies , 2006, Medical and Biological Engineering and Computing.

[59]  M.A. Herbert,et al.  Scoliosis treatment in children using a programmable, totally implantable muscle stimulator (ESI) , 1989, IEEE Transactions on Biomedical Engineering.

[60]  Frank Rattay,et al.  Electrical Nerve Stimulation: "Theory, Experiments And Applications" , 2001 .

[61]  D. Graupe,et al.  Patient controlled electrical stimulation via EMG signature discrimination for providing certain paraplegics with primitive walking functions. , 1983, Journal of biomedical engineering.

[62]  K H Mauritz,et al.  Restoration of standing, weight-shift and gait by multichannel electrical stimulation in hemiparetic patients. , 1994, International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation.

[63]  Barbara Tyldesley,et al.  Muscles, Nerves and Movement: Kinesiology in Daily Living , 1989 .

[64]  T Sinkjaer,et al.  Adaptive restriction rules provide functional and safe stimulation pattern for foot drop correction. , 1999, Artificial organs.

[65]  Lynn Snyder-Mackler,et al.  Clinical electrophysiology : electrotherapy and electrophysiologic testing , 1995 .

[66]  Liberson Wt,et al.  Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. , 1961, Archives of physical medicine and rehabilitation.

[67]  M. Popovic,et al.  PROGRAMMABLE AND PORTABLE ELECTRICAL STIMULATOR FOR TRANSCUTANEOUS FES APPLICATIONS-COMPEX MOTION , 2001 .

[68]  A. Eberstein,et al.  Electrical stimulation of denervated muscle: is it worthwhile? , 1996, Medicine and science in sports and exercise.

[69]  David W. Tank,et al.  Sealing cultured invertebrate neurons to embedded dish electrodes facilitates long-term stimulation and recording , 1989, Journal of Neuroscience Methods.

[70]  J. Norton,et al.  Patients' perceptions of the Odstock Dropped Foot Stimulator (ODFS) , 1999, Clinical rehabilitation.

[71]  W. Durfee,et al.  Methods for estimating isometric recruitment curves of electrically stimulated muscle , 1989, IEEE Transactions on Biomedical Engineering.

[72]  Brandell Br The study and correction of human gait by electrical stimulation. , 1986 .

[73]  D.B. Popovic,et al.  Machine learning in control of functional electrical stimulation systems for locomotion , 1995, IEEE Transactions on Biomedical Engineering.

[74]  R. Kobetic,et al.  Development and operation of portable and laboratory electrical stimulation systems for walking in paraplegic subjects , 1989, IEEE Transactions on Biomedical Engineering.

[75]  J. Lehmann,et al.  Gait abnormalities in hemiplegia: their correction by ankle-foot orthoses. , 1987, Archives of physical medicine and rehabilitation.

[76]  G. Herbison,et al.  Effect of electrical stimulation on denervated muscle of rat. , 1971, Archives of physical medicine and rehabilitation.

[77]  J. Mizrahi,et al.  Interaction of array of finite electrodes with layered biological tissue: effect of electrode size and configuration , 2001, IEEE Transactions on Neural Systems and Rehabilitation Engineering.

[78]  Frank Rattay,et al.  Electrical Nerve Stimulation , 1990 .

[79]  Moe Jh,et al.  Functional electrical stimulation for ambulation in hemiplegia. , 1962 .

[80]  A. Kralj,et al.  Programmed Six-Channel Electrical Stimulator for Complex Stimulation of Leg Muscles During Walking , 1979, IEEE Transactions on Biomedical Engineering.

[81]  M. J. Campbell,et al.  Tibialis anterior surface EMG parameters change before force output in multiple sclerosis patients , 1994 .

[82]  J A Oldham,et al.  The Use of Patterned Neuromuscular Stimulation to Improve Hand Function Following Surgery for Ulnar Neuropathy , 1994, Journal of hand surgery.

[83]  Ben Heller,et al.  Improved control of ankle movement using an array of mini-electrodes. , 2003 .

[84]  Thomas Stretch Dowse,et al.  MUSCLE AND NERVE , 1903 .

[85]  U. Bogataj,et al.  Restoration of gait during two to three weeks of therapy with multichannel electrical stimulation. , 1989, Physical therapy.

[86]  Christopher L. Vaughan,et al.  Dynamics of human gait , 1992 .

[87]  Joseph Hamill,et al.  Biomechanical Basis of Human Movement , 1995 .

[88]  N. Gros,et al.  Therapeutic effects of multisite electric stimulation of gait in motor-disabled patients. , 1987, Archives of physical medicine and rehabilitation.

[89]  H.B.K. Boom,et al.  Automatic stance-swing phase detection from accelerometer data for peroneal nerve stimulation , 1990, IEEE Transactions on Biomedical Engineering.

[90]  E C Hertzler,et al.  Compact stimulator using integrated circuits and battery power. , 1968, Journal of applied physiology.

[91]  Raymond C. F. Jones,et al.  Neuromuscular parameters, fatigue and function in MS , 1998 .

[92]  Stephens Wg The assessment of muscle denervation by electrical stimulation. , 1973 .

[93]  J. Kurtzke Rating neurologic impairment in multiple sclerosis , 1983, Neurology.

[94]  H.J. Chizeck,et al.  Neural network control of functional neuromuscular stimulation systems: computer simulation studies , 1995, IEEE Transactions on Biomedical Engineering.

[95]  M. Popovic,et al.  Multi-field surface electrode for selective electrical stimulation. , 2005, Artificial organs.

[96]  U. Bogataj,et al.  Application of a programmable dual-channel adaptive electrical stimulation system for the control and analysis of gait. , 1992, Journal of rehabilitation research and development.

[97]  G. Alon,et al.  Effects of electrode size on basic excitatory responses and on selected stimulus parameters. , 1994, The Journal of orthopaedic and sports physical therapy.

[98]  K. Yamakoshi,et al.  A new portable device for ambulatory monitoring of human posture and walking velocity using miniature accelerometers and gyroscope , 2004, The 26th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[99]  N. Gros,et al.  Multichannel electrical stimulation of gait in motor disabled patients. , 1984, Orthopedics.

[100]  A. Kralj,et al.  Functional Electrical Stimulation: Standing and Walking after Spinal Cord Injury , 1989 .

[101]  J. Barbenel,et al.  Peroneal stimulator; evaluation for the correction of spastic drop foot in hemiplegia. , 1996, Archives of physical medicine and rehabilitation.

[102]  A. McComas,et al.  Relationship between numbers and frequencies of stimuli in human muscle fatigue. , 1988, Journal of applied physiology.

[103]  G. Alon,et al.  The effects of selected stimulus waveforms on pulse and phase characteristics at sensory and motor thresholds. , 1994, Physical therapy.

[104]  J. Kurtzke,et al.  The Disability Status Scale for multiple sclerosis , 1989, Neurology.

[105]  V. Rohlíček A device for polarity alternation of pulses for biological stimulation , 2006, Medical electronics and biological engineering.

[106]  K. Y. Tong,et al.  Gait control system for functional electrical stimulation using neural networks , 2006, Medical & Biological Engineering & Computing.

[107]  R P Patterson,et al.  A functional electric stimulation system using an electrode garment. , 1990, Archives of physical medicine and rehabilitation.

[108]  N. Carlson Physiology of behavior , 1977 .

[109]  G. Lyons,et al.  An investigation of the effect of electrode size and electrode location on comfort during stimulation of the gastrocnemius muscle. , 2004, Medical engineering & physics.

[110]  P. Taylor,et al.  Experience of clinical use of the Odstock dropped foot stimulator. , 1997, Artificial organs.

[111]  F Sepulveda,et al.  An artificial neural system for closed loop control of locomotion produced via neuromuscular electrical stimulation. , 1995, Artificial organs.

[112]  F.E. Zajac,et al.  Restoring unassisted natural gait to paraplegics via functional neuromuscular stimulation: a computer simulation study , 1990, IEEE Transactions on Biomedical Engineering.

[113]  P. E. K. Donaldson,et al.  When are actively balanced biphasic ‘Lilly’ stimulating pulses necessary in a neurological prosthesis? , 2006, Medical and Biological Engineering and Computing.