재활로봇의중개연구와최신동향 2018 년 11 월 6 일 송원경 재활보조기술연구과장, 재활로봇중개연구사업단장 국립재활원
국립재활원 = 재활병원 + 재활연구소보건복지부소속기관, 서울강북구 미션 : 재활의료 연구 교육을통하여장애인의건강증진과사회복귀를실현하고, 국민의삶의질향상에기여한다. 재활병원 : 300 병상, 로봇보조치료실, 뇌졸중및척수손상아급성기환자군 재활로봇중개연구 : 병원과연구소를바탕으로외부기업 / 병원 / 대학 / 연구소와의협력 재활로봇보급사업 로봇보조치료실 Robot Assist Therapy Room (for therapy in hospital) National Rehabilitation Research 로봇짐 Robot Gym Institute (for Research) 2
Rehabilitation? Rehabilitation of people with disabilities is a process aimed at enabling them to reach and maintain their optimal physical, sensory, intellectual, psychological and social functional levels. Rehabilitation provides disabled people with the tools they need to attain independence and selfdetermination. World Health Organization http://www.who.int/topics/rehabilitation/en/ 4
Current domains of medical robots Jacobs, T., Veneman, J., Virk, G. S., & Haidegger, T. (2018). The Flourishing Landscape of Robot Standardization [Industrial Activities]. IEEE Robotics & Automation Magazine, 25(1), 8-15.
RACA: 재활 (Rehabilitation) 평가 (Assessment), 보상 (Compensation), 경감 (Alleviation) 산업용로봇안전 산업용로봇의안전에관한요구사항 (ISO 10218-1:2011) 비의료기기인개인지원로봇 (personal robots) 로봇및로봇장치 개인지원로봇안전요구사항 (ISO 13482:2014) 개발되고있는표준 재활로봇의안전에관한요구사항. IEC/NP 80601-2-78 IEC/NP 80601-2-78 은 Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability 재활 (rehabilitation) 뿐만아니라질병, 상해또는장애에대한평가 (assessment), 보상 (compensation), 경감 (alleviation) 을포함 Standardisation Newsletter, Standardisation Efforts on Industrial and Service Robots, https:// eurobotics.net/cms/upload/downloads/iso-standardisation-newsletter_2016-04.pdf
공산품 / 보조기기 / 의료기기 공산품 보조기기 의료기기 로봇기술 자율안전규격등 ( 전자파, 전기기계적안전성시험 ) 전자파, 전기기계적안전성시험품목허가, GMP
공산품 / 보조기기 / 의료기기다음판단절차를활용또는참고하여적용 의지보조용 의지보조기 의지보조목적표현? 비의지보조용 사용목적표현? 비의료용위해도? 낮음 비의료기기 높음 의료용 의료기기 전동식정형용운동장치 로봇보조정형용운동장치 DoA: 1~5 DoA: 6~10 Degree of Autonomy (DoA) Descriptive Method (IEC/TR60601-4-1)
Translational Research for Rehabilitation Robots 국립재활원재활로봇중개연구 Won-Kyung Song, NRC 13
Translational research: Crossing the valley of death Basic Research Valley of Death Clinical Research Nature 453, 840-842 (2008)
Engineering vs Clinical Terminology Engineering Terminology ( 기계중심 ) Clinical Terminology ( 사람중심 ) Active Passive Power-Assisted Active-Assisted Passive Active 송원경, 재활로봇동향과재활로봇중개연구, 한국로봇학회, 로봇과인간, 13(2), 2016.4, 3-9 (7 pages)
Engineering Development vs Clinical Research PICO Model http://researchguides.uic.edu/c.php?g=252338&p=1683349 Statistical Analysis P Patient, Population, or Problem 종속변수 ( 연속형 ) I Intervention, Prognostic Factor, or Exposure 두집단의비교 세집단의비교 C Comparison or Intervention (if appropriate) 짝지은자료 독립표본 모수적방법 ANOVA 다중비교 비모수적방법 Kruskal Wallis Test O Outcome you would like to measure or achieve 모수적방법 Paired T-tset 비모수적방법 Wilcoxon s Signed Rank Test 모수적방법 Student T-tset 비모수적방법 Mann Whitney U Test
재활로봇중개연구 재활로봇에특화, 2013 년부터시작 재활로봇의임상진입가속화 다부처협력 ( 산업부, 미래부, 교육부, 복지부 ) Basic Research T1 Clinical Research T2 Market + Improved Health 교육부미래부산업부복지부 재활로봇중개연구 (Translational Research for Rehabilitation Robots)
재활로봇중개연구의사례 재활로봇중개연구 Balgrist University Hospital (Zurich, Switzland) Rehabilitation Institute of Chicago Spaulding Rehabilitation Hospital, Boston University of California at Irvine Fujita Health University (Japan) 재활로봇중개연구에있어필수조건 Hospital-based research space Multidisciplinary collaborative research team Active participatory patients (Research Participant Registry & Research Ward) Government-supported R&D funds and promotion programs
재활로봇중개연구구성 (1) 재활로봇중개연구용역 기업 / 연구소 / 학교의중개연구지원 ( 중 소규모재활및로봇관련영세업체, 연구소, 학교지원등다양한경로를통한연구결과물을대상으로함.) (2) 재활로봇중개내부연구 중개연구기반확보를위한내부연구 ( 선진재활로봇에대한임상연구, Reverse 중개연구, 기존기술중개연구등 ) 재활로봇테스트베드 ( 로봇짐 )
유연한착용형손로봇상용화개발 ( 서울대학교, 2015, NRCTR-EX-15001) 척수손상환자, 초기뇌졸중환자의손기능보조를통한일상생활지원을위한착용형손로봇상용화 상용화적합성평가및디자인요소선정및반영 기능성, 사용안전성을고려한제어알고리즘개발및반영 개발된유연한착용형손로봇의 feasibility test 공인기관의전기기계적안전성평가
재활로봇중개연구를통한경험 중개연구시작전의연구결과필요 핵심기능만남기고단순화, 차별화 시험검사, 허가 학교 + 기업연계 새로운아이디어도출 전문가와당사자 (End Users) 의참여 용역과제와내부연구의연계성강화 ( 적응증확대 ) 중개연구에대한지속적인관심
재활로봇테스트베드 - 재활로봇짐 2014. 10. 31~, 중개연구공유공간. 도입된장비의임상적용및운용노하우축적 선진기술분석및임상연구를위한선진로봇과국산재활로봇의임상효과비교
15m 7.5m 22.8m 234m 2 14.4m
도입장비 : 체계적인활용시작, 데모 / 견학환영, 장비사용기록 디바이스 G-EO SYSTEM Proficio K4B2 Armeo Power/Spring 특징 End-effector 형보행재활로봇으로다양한측정기기와의탈부착이용이하여임상실험및새로운보조기구의평가가가능함가상공간의설정을통하여산책로를걷거나평평한, 계단, 경사, 장애물, 지형등의여러가지훈련이가능소아재활모듈이있어소아를포함한다양한장애인군의보행재활을위한임상연구와치료에활용가능 다양한신경재활과관련된기능을 Open Source 로구현하고있으며양팔의움직임에대응할수있고 Bi-Manual Movements 가능함최신 neurorehabilitation 이론즉 error augmentation, deficit fields, negative viscosity, active impedance 및 intention remediation 을사용하여로봇지원형연구방법의개발과접근가능 장소의제한없이운동선수및장애인들의인체의활동및운동시에호흡대호흡법으로연속적인인체의호흡가스및대사량 ( 소비칼로리 ) 을측정할수있는시스템 Armeo Power: cerebral, neurogenic, spinal, muscular or bone 관련질환에의해상지에장애요인이있는환자에게조금의기능도거의남아있지않다면, 고강도의반복훈련을통한초기재활치료에필수적인로봇임 Armeo Spring: 상지에장애요인이있는환자에게움직임을시작하는말단의일부남아있다면 Armeo Spring 은자발적인움직임을시작하는데도움줌
의료기기허가획득 (2015.11.): 중증장애인의지면보행이가능한외골격형태의하지재활로봇 재활로봇임상진입을위한중요조건인의료기기허가완료 시작품을바탕으로개선한새로운시제품제작하여공인기관안전성평가및식품의약품안전처의료기기허가완료 사용성평가, 임상시험진행및디자인개선을통한상품화예정 의료기기제조인증서 : 정형용운동장치 A67020(2) 의료기기제조및품질관리기준적합인정서 (GMP) 40
의료기기허가추가획득 (2016.7.): 중증장애인의지면보행이가능한외골격형태의하지재활로봇 장애인및전문가피드백을통한개선포인트도출 개선된제품에대한의료기기허가추가획득 정동식정형용운동장치 임상적용을통한유효성검증추진 다양한대상자및환경에서의임상적용을통해상용화기반마련필요
Armeo Power Hocoma i Key Points Early rehabilitation training for severely affected patients Extensive 3D workspace (6 actuated dof) Assist-As-Needed support automatically adapts to patient s capabilities Augmented Performance Feedback increases motivation and trains activities of daily living Assessment Tools for objective analysis of patient s progress Klamroth-Marganska et al., Three-Dimensional, Task-Specific Robot Therapy Of The Arm After Stroke: A Multicentre, Parallel-Group Randomised Trial, Lancet Neurol. (2014) Armeo Power (Hocoma, Zurich) Examples for new technologies 45
KINARM Exoskeleton Lab BKIN Technologies Ltd i Key Points Assessment of range of neurological impairments associated with stroke, spinal cord injury, CP, Parkinson s Quantitative and objective measures of brain function and dysfunction through precise measurement of human behaviour Supports clinical researchers in the development of novel therapies for improved outcomes Semrau, J.A. et al. Robotic identification of kinesthetic deficits after stroke. Stroke. 44:3414-3421 (2013) KINARM Exoskeleton Lab (BKIN Technologies Ltd., Canada) Examples for new technologies 46
재활로봇중개연구용역평형점이론에기반한뇌졸중환자의정적힘측정을통한다수지운동제어평가 ( 경희대학교심재근, 2017~2018, NRCTR-EX17009) 뇌졸중환자의손기능평가장치 (SHEA) 를이용하여운동제어평형점이론에기반한뇌졸중환자와비장애인손의특성측정분석알고리즘개발 시너지, 계층적, 반구간상호작용측정소프트웨어및사용자인터페이스고려개발 임상시험완료 ( 뇌졸중장애인 12 명, 비장애인 16 명 )
재활로봇중개연구용역상지다관절기계적임피던스추정로봇시스템개발및응용 (UNIST 강상훈, 2017-2018, NRCTR-EX17012) Sensor signal Control command 상지다관절기계적임피던스추정방법및기기설계에대한검증 기존보다컴팩트한상지다관절기계적임피던스추정로봇시스템개발 ( 베이스고정형 ) 상지다관절기계적임피던스추정로봇시제품 1 건 subject enable switch 3D Perturbations Real-time control/monitoring (force, disp, vel) User(clinician) enable switch
KineAssist-MX HDT Global i Key Points Driven by patient intent Reinforces neurological pathways and muscular systems Helps muscles relearn and reconnect through feedback and self initiation Transparent interaction with therapist Patients exercise at their own pace and with their own gait patterns Challenge-based training allows patients to safely learn from their mistakes and exceed their current capabilities Patton J, Lewis E, Crombie G, Peshkin M, Colgate E, Santos J, Makhlin A, and Brown DA: A novel robotic device to enhance balance and mobility training post-stroke. Topics in Stroke Rehabilitation 15.2: 131-9. 2008 KineAssist-MX, HDT Global, Fredericksburg, VA USA Examples for new technologies 60
Erigo Pro Hocoma i Key Points Early and safe mobilization of severely impaired patients even in acute care Progressive verticalization up to 90 Cyclic leg movements 8-80 steps/min Cyclic leg loading (up to 50 kg) allows enhanced cardiovascular output Improved orthostatic tolerance through Functional Electrical Stimulation (FES) Sensorimotor stimulation improves patient awareness Yoshida et al., Cardiovascular response of individuals with spinal cord injury to dynamic functional electrical stimulation under orthostatic stress, IEEE Trans Neural Syst Rehabil Eng (2013) Erigo Pro (CHUV, Lausanne) Examples for new technologies 63
Part of Body 재활로봇 (1) 치료재활로봇 ( 병원 ), (2) 일상생활보조로봇 ( 가정 ), (3) 돌봄로봇 ( 병원, 가정 ) RoBear Care/Nursing D Free HAL Melvin Therapeutic Rehabilitation Hand/ Finger Armeo Power Upper Armeo Spring Extremity ReeGO Hand of Hope Haptic Drive Amadeo Pablo Arm Assist KINARM Lab MIT Manus Myomo ADL Assist (@Home) SEM Glove JACO ARM Trunk KineAssist Erigo Lokomat KineAssist MX Bionic Leg Andago Walkaround Lower G-EO System Erigo ZeroG ReWalk Extremity Motion Maker Indego Ekso FirstMover ReoAmbulator Walkbot_S Modified form (Song, 2016, Biomedical Engineering Letters) TYMO CAREN Valedo Motion VirtualRehab Smart Mobile Walker Soft Suit 67
연령별장애분포 (Age-specific disability prevalence) 고령화에따라장애인구가늘어남 ( 출처 : WHO, 59 개국 ). 75 세이상의경우 50% 이상이장애를가짐
ROBEAR: The strong robot with the gentle touch https://www.youtube.com/watch?v=j3eddapsdy4
HWRS-ERC (1999. 7.~ 2007. 6., 9 년 ) 사람과더불어일하면서사람을돕는서비스로봇시스템설계및구현기술확보 차세대복지산업기술의초석마련 노약자장애인 노약자와장애인의독립적인생활보장 인간친화적인시스템개발 76
< 그림 6> 일본로봇개호기기개발중점분야 이승보조 ( 장착, 비장착 ) 이동지원 ( 옥외, 실내, 장착 ) 배설지원 ( 배설물처리, 화장실유도, 동작지원 ) 지킴모니터링 ( 시설, 재택 ) 목욕지원 개호업무지원 2017 년 10 월 4 개분야에서 5 개서비스가추가됨 ( 붉은색박스 ).
Mobile Manipulators Clinicians can safely tele-operate mobile robots to treat patients with highly infectious diseases such as Ebola Virus Disease.
Patient simulators Over 180,000 clinicians annually train on high fidelity robotic patient simulators, which can simulate physiological cues, and sense and respond to learners.
Mental and Behavioral Healthcare Robots can support people with cognitive impairments, facilitate neurorehabilitation, support wellness, or provide companionship.
Physical task support Robots can support people with motor impairments, movement disorders, and brain injuries to provide external manipulation capabilities.
Welfare robot Melvin MELVIN is an assistive device that can make an essential difference. Not only for municipal economy and time, but also and in the highest degree for its users. MELVIN solves a well-known problem for users and care givers. MELVIN increases the users' degree and sense of self-reliance and preserved dignity. MELVIN pays off in less than a year and frees up funds for other welfare. http://www.en.mymelvin.com/
취약계층의전주기돌봄지원 94
돌봄 재활기술서비스기반구축의료공공성확보및환자중심의료서비스제공 - 공익적가치중심의료연구기반확대 노인 장애인을위한생활밀착돌봄 재활로봇및보조기구개발 제품화등에걸친체계적이고종합적인연구개발 (R&D) 지원 1 최중증장애인 와상노인의돌봄 ( 스스로생활, 일어서기 ) 2 한국의실정 ( 시설, 가정 ) 에적합한기기및서비스연구개발 3 수요자함께연구 실시 ( 당사자, 개호자, 전문가전단계참여, 의사소통원활 ) 4 개발, 사용방법교육, 보급을고려한서비스까지의생태계구축 5 데이터기반지속가능한연구개발및실증환경조성 ( 지속적지원, SW)
외골격
Comparing Indego vs Ekso GT vs ReWalk (by VAPAHCS) http://exoskeletonreport.com/2016/09/comparing-indego-vs-ekso-gt-vs-rewalk-researched-vapahcs/
Ekso Adjustable assistance levels Variable assist Peak torque of 150 Nm Battery, computer and portable compressor in bag pack Encoders and linear accelerometers used as sensors. 100,000 USD cost Costly exoskeleton mainly sold to hospitals 6-h battery life Wearers: 157cm~192cm tall. weigh <100 kg
Variable Assist Variable Assist allows individuals with any amount of lower extremity strength to contribute their own power from either leg while Ekso fills in the deficit. Variable assist software allows for necessary customization and it has become a game changer Dr. Karen Nolan Assist options: Maximum Assist-100% motor power Adaptive Assist-continually adapts dependent upon patients effort Fixed Assist-set max motor assist 0-100 Free-no motor support[2] https://exoskeletonreport.com/2016/02/clinical_trials_with_ekso_gt/
EksoPulse Analytics A cloud-based solution to deliver utilization metrics for rehabilitation. Ekso GT can help rehabilitate patients after a stroke or SCI. Now with EksoPulse you can help improve productivity in physical therapy and deliver a more personalized approach in rehabilitation
다양한외골격로봇 (Werob 2016). Exoskeleton for Research: Hank, H2 New opportunity (SW) vs Red ocean 단, Low Level 의데이터를제공하는로봇은많지않음. Ekso Hank ( 70k) H2 ( 50k) Lower limb design architectures developed at EPFL MiRAD Spring-Clutch ankle unpowered exoskeleton (G. Sawicki) Modular, personalized exoskeleton for ankle and knee support BioMot
ReWalk: Training Center
ReWalk Launches Clinical Study for Its ReStore Soft Exo-Suit System (Date: April 3, 2018)
ReWalk Launches Clinical Study for Its ReStore Soft Exo-Suit System (Date: April 3, 2018) How It Works: The ReStore transmits power to key joints of the legs with cable technologies, powered with software and mechanics that are similar to the technologies used in the ReWalk exoskeleton system for individuals with spinal cord injury. The cables are connected to fabric-based designs that attach to the legs and foot, thus lending the name soft suit. Anticipated delivery of a commercial ReStore soft suit is targeted for the first half of 2019. ReWalk plans to commercialize use of the ReStore system in Europe and the United States subject to receiving CE and FDA clearance, respectively, to market the device. The Company plans to apply for CE and FDA clearances once clinical and laboratory testing are completed.
요약 RACA: 치료재활 (Rehabilitation) + 평가 (Assessment) 고령화 : 공산품 / 의지보조기 의료기기 가정용 상지 / 하지뿐만아니라체간 돌봄로봇의다양한가능성 외골격로봇의적응증확대 외골격 소프트외골격 교육프로그램 인공지능