McCaughey, Euan James (2014) Abdominal functional electrical stimulation to improve respiratory function in acute and sub-acute tetraplegia. PhD thesis. http://theses.gla.ac.uk/5471/ Copyright and moral rights for this thesis are retained by the author A copy can be downloaded for personal non-commercial research or study, without prior permission or charge This thesis cannot be reproduced or quoted extensively from without first obtaining permission in writing from the Author The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the Author When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given Glasgow Theses Service http://theses.gla.ac.uk/ [email protected] ABDOMINAL FUNCTIONAL ELECTRICAL STIMULATION TO IMPROVE RESPIRATORY FUNCTION IN ACUTE AND SUB-ACUTE TETRAPLEGIA Euan James McCaughey, MEng Submitted in fulfilment of the requirements for the Degree of Doctor of Philosophy (PhD) Submitted to the School of Engineering, College of Science and Engineering, University of Glasgow August 2014 . (cid:13)c Copyright 2014 by Euan James McCaughey, MEng. All Rights Reserved. i Abstract An injury to the cervical region of the spinal cord can cause paralysis affecting all four limbs, termed tetraplegia. People with tetraplegia also have paralysis or impaired function of the major respiratory muscles, namely the diaphragm and intercostal and abdominal muscles. This often reduces respiratory function, with associated respiratory complications a leadingcauseofmorbidityandmortalityforthispopulation. AbdominalFunctionalElectrical Stimulation (AFES), the application of electrical pulses to the abdominal muscles causing themtocontract,hasbeenshowntoimproverespiratoryfunctionintetraplegia. Despitethese positive results, further work is needed to establish AFES as a standard clinical treatment. The aim of this thesis is to support the clinical introduction of AFES. This was achieved by addressing two primary objectives. Firstly, the development of new technologies and protocols to optimise AFES for use in a clinical setting. Secondly, the clinical evaluation of these technologies and protocols with tetraplegic patients. For research purposes, AFES has typically been applied manually, requiring an operator to synchronise stimulation with respiratory activity. One important step necessary for the clinical introduction of AFES is the development of an automated AFES device that can apply stimulation in synchrony with the users respiratory activity, with different stimulation parameters applied for different breath types such as a quiet breath and a cough. In this thesis, the signal from a non-intrusive respiratory effort belt, worn around the chest, was used to develop a statistical classification algorithm capable of classifying respiratory activity in real-time, and applying AFES in synchrony with the user’s respiratory activity. The effectiveness of AFES can also be enhanced by stimulating at the abdominal muscle motor points. Inthis thesis the positionsof the abdominal motorpoints were locatedsystematically for the first time, in ten able bodied and five tetraplegic participants. To aid the clinical introduction of AFES it is necessary to establish the patient groups who would benefit most from this intervention, and to develop appropriate clinical protocols. This is addressed in two clinical studies, where the feasibility and effectiveness of AFES to improve the respiratory function of the acute ventilator dependant and sub-acute tetraplegic populations was demonstrated. In the first study, conducted with 10 acute ventilator dependant tetraplegics, AFES was applied on alternate weeks for a total duration of eight weeks. This resulted in acute improvements in breathing and led to a longitudinal increase ii in respiratory function over the study duration. It was found that participants weaned from mechanical ventilation on average 11 days faster than matched historic controls. Previous work, which investigated the effect of a three week AFES training programme on the respiratory function of people with sub-acute tetraplegia, suggested that an extended AFES training programme may be more effective. In the second clinical study in this thesis, a continuous eight week AFES training protocol (combined with a six week control period) was evaluated with three sub-acute tetraplegic participants. The application of AFES led to an acute increase in respiratory function, with a longitudinal improvement in respiratory function observed throughout the study. In a single participant case study, the feasibility of combining AFES with assisted coughing delivered by mechanical insufflation-exsufflation was demonstrated for the first time. This was shown to lead to an acute improvement in respiratory function at six of the eight assessment sessions, indicating that this technique could be used to aid secretion removal. This thesis highlights the feasibility and effectiveness of AFES to improve the respiratory functionoftheacuteventilatordependantandsub-acutetetraplegicpopulations. Theclinical protocols that enable AFES to be used with these patient groups, and the technological developmentsdetailedthroughoutthisthesis, areanimportantsteptowardstheintroduction of AFES as a regular treatment modality. iii Acknowledgements The list of people who have helped me get to this stage is too long to be covered in this acknowledgments section. However, the following people have played a major part in helping me get to the stage of completing this thesis. Firstly, I would like to thank Dr. Henrik Gollee for his supervision throughout my PhD. His support, encouragement and ideas have helped to guide me through this process. Much of what I have learned over the past few years is attributed to you and for this you have my sincere thanks. At the Queen Elizabeth National Spinal Injuries Unit (QENSIU) I would like to thank the consultants Alan McLean, Mariel Purcell and Matthew Fraser, as well as the director David Allan, for providing the knowledge, support and facilities to undertake cutting edge research with the spinal cord injured population. For a mechanical engineer to come into a clinical researchsettingwasachallenge,butitwasonethatIthoroughlyenjoyedandtookagreatdeal of fulfilment from. The research driven environment that has been created at the QENSIU provides an excellent platform for researchers to transfer knowledge gained in the lab to the clinical setting, with a great benefit for the spinal cord injured population. I would like to thank all at the QENSIU for helping create and maintain this unique research environment andIhopethecollaborationwiththeUniversityofGlasgowcontinuesformanyyearstocome. I would also like to acknowledge the various colleagues I have worked with within the Centre for Rehabilitation Engineering over the course of my PhD. Every one of you was a source of knowledge and encouragement and I will continue to offer you my whole hearted support at all times. A special thanks goes to Angus McLachlan who acted as a mentor through my masters project and the first year of my PhD. The knowledge and advice you passed on, even when you had left the group, played a major role in the success of this project. I wish you every success with your career in America and hope that maybe we can work together again at some point in the future. To all the volunteers who took part in the various studies outlined in this thesis I would like to extend my thanks. Thank you for your patience and understanding when things were not going to plan. I only hope you got the same amount of enjoyment out of taking part in the iv studies as I got from working with you. I would like to acknowledge the EPSRC for the financial support provided to allow me to conduct this PhD. The unfaltering support of my friends and family throughout this PhD has meant a lot to me. Spending time with those close to me has helped me to overcome the stressful periods, of which there were many, and helped me to unwind. Finally, I would like to thank my wife Laura. Your support, mainly in the form of putting up with me, has meant so much over the last few years and will be rewarded with many cups of tea during your write up period! Thank You! “We must not forget that when radium was discovered no one knew that it would prove useful in hospitals. The work was one of pure science. And this is a proof that scientific work must not be considered from the point of view of the direct usefulness of it. It must be done for itself, for the beauty of science, and then there is always the chance that a scientific discovery may become like the radium a benefit for humanity.” Marie Curie v Author’s Declaration I declare that, except where explicit reference is made to the contribution of others, that this thesis is the result of my own work and has not been submitted for any other degree at he University of Glasgow or any other institution. All of the analysis and data collection techniques presented in this thesis were created by the author. E.J. McCaughey August 2014 vi Abbreviations SCI: Spinal cord injury FES: Functional electrical stimulation AFES: Abdominal functional electrical stimulation QENSIU: Queen Elizabeth National Spinal Injuries Unit RTAs: Road traffic accidents ASIA: American Spinal Injuries Association AIS: ASIA impairment scale UMN: Upper motor neuron LMN: Lower motor neuron V : Tidal volume T V /kg: Weight corrected tidal volume T CPF: Cough peak flow MEP: Maximum expiratory pressure MIP: Maximum inspiratory pressure V : Vital capacity C FVC: Forced vital capacity FVC/kg: Weight corrected forced vital capacity V /kg: Weight corrected vital capacity C ATS: American Thoracic Society ERS: European Respiratory Society FEV : Forced exhaled volume in one second 1 NMES: Neuromuscular electrical stimulation TENS: Transcutaneous electrical nerve stimulation IMV: Intermittent mandatory ventilation SBT: Spontaneous breathing trial MI-E: Mechanical insufflation-exsufflation RMT: Respiratory muscle training PNP: Phrenic nerve pacing DP: Intramuscular diaphragm pacing SCS: Spinal cord stimulation iSCS: Intercostal spinal cord stimulation aSCS: Abdominal spinal cord stimulation vii EMG: Electromyograph SVM: Support vector machine RBF: Radial basis function IMU: Inertial measurement unit SaPO : Oxygen saturation level 2 GUI: Graphical user interface PCC: Pearson product-moment correlation coefficient ANOVA: Analysis of variance FFT: Fast fourier transform MP: Motor point RA: Rectus abdominis EO: External oblique CoR: Coefficient of repeatability BoTN-A: Botulinum toxin A EV: Exhaled volume PF: Peak flow RCT: Randomised control trial viii Contributions • In this thesis novel Abdominal Functional Electrical Stimulation (AFES) protocols and technologiesaredevelopedandimplemented,anditisshownthattheycanhelpimprove the respiratory function of the acute ventilator dependant and sub-acute tetraplegic population. Demonstration of the feasibility and effectiveness of these technologies and protocols is a necessary step towards the implementation of AFES as a clinical treatment modality. As such, a key contribution of this thesis is proof of feasibility. • By using the respiratory data recorded from 10 able bodied participants a novel algorithm for non-intrusive real-time breathing pattern detection and classification has been designed and tested. The use of a non-intrusive sensor, coupled with an improved and less operator reliant classification algorithm, makes this method more suited to a clinical setting than previous work where the signal from an intrusive spirometer was used for breathing pattern classification. • Neuromuscular electrical stimulation has been used for the first time to systematically detect the position of the motor points of the abdominal muscles. By applying single pulse electrical stimulation to the rectus abdominis and external oblique muscles, the positionofthemotorpointsofthesemusclesweresuccessfullylocatedin10ablebodied and five tetraplegic participants. The position of the motor points of these muscles, along with the repeatability and uniformity of the position, is presented. The results of this study suggest that this method could be used to accurately detect the position of the abdominal muscle motor points to select the optimum electrode location for the application of AFES. • In the main clinical study of this thesis the feasibility of using AFES to improve the respiratory function of acute ventilator dependant tetraplegics is shown. To use AFES with this patient group a number of adaptations to standard AFES protocols were required. NovelengineeringsolutionstoallowAFEStobesynchronisedwithmechanical ventilation, or with the user’s own breathing, are presented. A novel training protocol, designed to improve respiratory function while allowing the effectiveness of AFES to be evaluated, was also developed. The gains in respiratory function achieved using these
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