Modern Medicine. Modern Rehabilitation. Ro-bot-ics /rōˈbätiks/ n. 9/28/2013

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1 Objectives Integration of Robotics into Clinical Practice Teresa Wong, PT & Darrell Musick, PT WHAT? Basic definitions and terminology Know the various categories and groups WHY? Importance of robotic technology today? The value of robotic technology on clinical outcomes HOW? Evaluate equipment for clinical integration Understand how robotics technology might impact our future Development and Evolution of a Technology Robotica Exoskeleton Telemedicine RR Technology Neuroplasticity Virtual-Reality Ekso-Bionics Tibion MIT-MANUS Lokomat Prosthetics Robots Actuators Mechatronic Devices Biorobotics Haptic Interface Neuromotor Recovery Brain Chips Roboethics Nanorobotics Intelligent Wheelchairs Myomo Ro-bot-ics /rōˈbätiks/ n. Design, construction, and use of machines (robots) to perform tasks done traditionally by human beings Modern Medicine Living Well Recover Faster and Better Deaths Disability Modern Rehabilitation Better Outcomes More Efficient Less Resources 1

2 Neuroplasticity REHABILITATION VS RECOVERY How entire brain structures, and the brain itself, can remodel through SENSORY EXPERIENCE restore to basic function restore to highest function 1-2 months 6 months to 2 years 3 rd payor control Consumer control CONSTANT CONTINUOUS RESPONSIVE John Medina,PhD Developmental Molecular Biologist Physical Facts Weighs about 3 pounds like tofu or custard Largest brain to body ratio No pain receptors can t feel pain 75% water 100 billion Neurons Uses 20% of total body s oxygen Development Function Size of brain at birth is almost same size as adult Stops growing at age 18 Stimulation can make or - 25% diff in ability to learn (language, environment, music) Can make new neurons throughout lifetime in response to stimulus Brain cells to die at 4-6 mins without oxygen Permanente damage after 5-10 mins Can t tickle yourself brain differentiates external vs. internal stimulus Every new thought creates a new connection Brain creates memory during sleep dream showing Blink brain has to keep things on Laughing affects five areas of the brain (300 vs. 15) Average women speaks 7,000 words a day, a man speaks 2,000 2

3 Brains are NOT the same Albert Eistein 35% wider area in area responsible for math and spatial perception London taxi drivers large hippocampus due to need to memorize all streets by heart Blind much larger representation of their reading finger Musicians much larger representation of their fingering hand Principles of Neuroplasticity Neuroplasticity Principled Rehabilitation Model Usage of body part increases brain representation 1. Skilled/Precision Tasks These should be performed to facilitate neuroplastic changes, and subsequently improvements in motor behaviour. (vs. Strength Training) Premotor cortex can substitute for motor cortex 2. Negative effects or Presence of Pain. Pain alters excitability of the primary motor cortex in a rapid manner, these responses are generally protective and counterintuitive in the motor-learning process. May result in unwanted cortical neuroplastic chang Contralesional hemisphere can take over motor control These mechanism can be facilitated Rehabilitation Goal Control this remodeling in the right direction and correct it if it s taken a wrong turn. Negative effects are also demonstrated in the presence of low quality sleep, stress, and attention deficits. Therefore, motor-skill learning should be relatively pain free 3. Cognitive Effort The greater the complexity of a specific tast and it s corresponding intent will result in greater cortical representation and changes 4. Quality Focus of each session should be on quality of performance since increasing repetition has demonstrated no difference in within session skills learning Performance Skills Training Technology - WHAT does it do? RESULTS Intensity Consistency Precision Complexity Enjoyable 3

4 Body Weight Support Rehabilitation Robotics Devices that assist patient or therapists with activities that optimizes function. CATEGORIES RESTORATIVE MAINTAIN FUNCTION ASSIST WITH LIVING CONSIDERATIONS Adjustable, Progressive, Measurable Unobtrusive, Durable, Ease of Use Safe, Reliable, Durable Virtual Reality EEG Technology Moving Things with Only Your THOUGHTS? Posturography Motion Analysis 4

5 TeleRehabilitation Robotic Development HSR (Human Support Robot) RIBA (Robot for Interactive Body Assistance RoBa1l Remote Delivery & Self Management Ubot-5 Humanoid Wearable Robots 1 st Generation Wearable Robots Exoskeleton Robotic Extenders Extends strength of human beyond it s natural ability but under human control Orthotic Robots Matches human anatomy and complements lost function or weakness Prosthesis Robots Substitutes for lost limb after amputation Net power with robot to overcome human physical limits Equipment Considerations What does it do / not do? How big and how much space? Who can benefit, adaptable? How easy is it to operate, don/doff? How much time does it take? How comfortable for patients? Energy Cost? How much benefit vs other solutions? How much does it cost? Potential for take home program? SAFETY Clinical Considerations What advantages does it offer patient or therapist? Quantifiable results Safety and proper support Decrease negative neuro responses Increase intensity of activities What are the barriers to clinical utilization? Time Comfort Ease of use What are the most important features for clinical implication? Clear value add Adaptibility 5

6 What does IT do? vs What do YOU want to do? Robot Human Interaction Actuators and structure transmits force to the human musculoskeletal system Through Control and Flow information, power, sensors and biofeedback Powerful and Immediate sensory Experience Tibion BIONIC LEG Facilitate Strength, Stability and Balance Integrating Robotics Example Tibion Robotic Leg Can Affect STRENGTH BALANCE PROPRIOCEPTION May Affect SPASTICITY FLACCIDITY MOTOR CONTROL Will Not Affect RANGE OF MOTION COGNITIVE TRAINING ABNORMAL REFLEXES Evolution What s in our future? 6

7 August 26, 2013 Bionic Skin for a Cyborg You Flexible electronics allow us to cover robots and humans with stretchy sensors Exoskeletons in Rehabilitation 2013 Ekso GTtm Development & Evolution of a Robot Technology Rex ReWalk Honda Indego Ekso Development 2010-Present Initial Clinical Testing: Safety Prototype to Compensation Device Device modification (Usability) Clinical Application(s) (Functionality) Clinical Training Program Patient and Therapist learning curves Inclusion/Exclusion based on success and failures Kessler Institute, West Orange, NJ Spaulding Rehabilitation Hospital, Boston, MA Craig Hospital, Denver, CO Mt. Sinai, New York, NY Rehabilitation Institute of Chicago, Chicago, IL Rehabilitation Institute of Michigan, Detroit, MI TIRR, Houston, TX Santa Clara Valley Medical Center, San Jose, CA Rehabilitation Hospital of the Pacific, Honolulu, HI Good Shepherd Hospital, Allentown, PA 7

8 Initial Clinical Testing: Safety 63/70 qualified into trial(s) 7 Screen Failures: unknown WB status (1); ROM deficits (5), weight (1) No Adverse Events Session 1 totals 63/63 able to ambulate feet during session 1 Session 1 final device: 45 Walker; 16 Crutches; 2 HMI Determined Inclusion/Exclusion For complete and incomplete SCI incomplete Enough upper extremity strength to manage assistive devices Medically stable and candidate for full weight bearing gait training Height range from 5 2 : 6 2 Weight under 220 lbs Near normal LE ROM (-10 hips, -10 knees, neutral ankles) Reasonable Spasticity Average first session: ~300 steps Kessler Foundation 33 y/o male S/P MVA 1999 T12 AIS A Paraplegia: Compensation Device 45 y/o male S/P MVA 2005 C5 AIS D Tetraplegia August 2012: Advanced Feature Upgrade: User initiation T12: AIS A Paraplegia 8

9 2013: Variable Assist Software Upgrade CVA/Incomplete SCI/Other Key Variable Assist Features as a Rehabilitation Device Type of Injury: Bilateral vs. R/L Affected Assistance: Fixed swing path assistance from Or, Adaptive mode for variable assistance as needed during individual swing phase for each leg R/L Affected: Affected LE either Fixed/Adaptive for weakest LE Stance support for Free Leg if needed Swing Complete function (if fixed assistance is too low, or, patient too slow) Fast, Medium, Slow Allows patient time to recruit and complete step when near threshold of strength Heelstrike indicator (on/off as desired) New Foot Trigger (ProStep ): initiates step with sensors (Toeoff) Baseline calibration (on/off as desired) 2013: Variable Assist Software Upgrade CVA/Incomplete SCI/Other Feedback Tools to enhance Variable Assist for Rehabilitation Feedback Tools to enhance Variable Assist Feedback on Walk Screen: *Displays 5 step average of Min Forward Assistance needed to complete a step LIFT, EXTD, or L&E Swing notifications Detailed Feedback Screen: 5 step average Forward Assistance: Average Ekso assistance provided in the forward direction *Minimum Assistance: Min Forward Ekso Assistance needed to complete a step Path Assistance: Amount of assistance provided to the pilot to keep them on the path or gait trajectory. Case Study 1 33 y/o female S/P MVA 1/2012 L1 AIS C Paraplegia 33 y/o female S/P MVA 1/2012 L1 AIS C Paraplegia Case Study 2 Case Study 3 33 y/o female S/P AVM Ataxia; Dysarthria; Bilateral involvement Bilateral using Adaptive Assist R Affected, Adaptive Assist w/ Stance Support 19 y/o S/P AVM repair Flaccid Left Hemiplegia Ambulatory with LBQC and Min (A) x 30 9

10 Case Study 3: 19 y/o S/P AVM repair Case Study 3: 19 y/o S/P AVM repair Pre Ekso walk First steps: Bilateral Adaptive Left Affected; Adaptive assist Left Affected, Fixed; swing complete Case Study 3: 19 y/o S/P AVM repair Case Study 4: Dr. K Pre Ekso Post Ekso 66 y/o s/p R CVA w/ L hemiparesis Date of onset: 9/5/10 Rehab/outpatient standard Continues w/ 2-3 hours of PT/day (Private PT) 4 Ekso sessions: Steps between 243 and 706 in 45 sessions Case Study 4: Dr. K Case Study 4: Dr. K 10

11 This image cannot currently be displayed. This image cannot currently be displayed. This image cannot currently be displayed. This image cannot currently be displayed. This image cannot currently be displayed. 9/28/2013 Preliminary Research with Variable Assist software w/ post CVA patients Subject One: CVA Preliminary Data L CVA/R Hemi Ambulatory with R AFO and Hemi-walker 4 sessions in Bilateral/Adaptive Walk Time: 7m 53s 6m 19s 11m 44s 17m 19s Up Time: 34m 44s 28m 55s 42m 43s 48m 14s Total Steps: Pre Post 5/29/2013 6/14/ MWT 70.04'; CGA with hemi walker 31.41' CGA with hemi walker 6 MWT 161.7'; CGA with hemiwalker 297'; CGA with hemi walker RPE 13 9 BBS 21/56 28/56 5x STS 31.03' 37.0 (Post 422 steps) 28-Sep-13 Copyright 2012 Ekso Bionics, Inc. All rights reserved. Proprietary 62 Subject Two: CVA Preliminary Data Subject Three: CVA Preliminary Data 66 y/o L CVA/R Hemi April 2013 Non Ambulatory (Lives in SNF) 3 sessions in Bilateral/Adaptive Walk Time: 2m 19s 8m 26s 12m 56s Up Time: 13m 43s 37m 47s 39m 46s Total Steps: L CVA/R Hemi Non-Ambulatory in PT (Never walked due to pushing Syndrome ) 4 sessions in Bilateral/Adaptive Walk Time: 9m 49s 8m 22s 20m 45s 18m 58s Up Time: 34m 18s 26m 48s 104m 24s 47m 40s Total Steps: Pre Post 5/29/2013 6/14/ MWT Unable Unable 6 MWT Unable 12 ; In Parallel bars with A x2 RPE N/A N/A BBS 3 3 5x STS Unable Unable Pre Post 5/29/2013 6/14/ MWT Unable P Amb 9.4 in 3m 56s 6 MWT Unable 18.4 with x2 seated rest breaks RPE N/A N/A BBS 4 3 5x STS N/A N/A 28-Sep-13 Copyright 2012 Ekso Bionics, Inc. All rights reserved. Proprietary Sep-13 Copyright 2012 Ekso Bionics, Inc. All rights reserved. Proprietary 64 Exoskeleton Research Review Soft signs during device testing Improved endurance Increased confidence Improved balance (sitting/standing) and weight shifting Increased alertness Improved overground walking following Ekso session Ekso GTTM :Fall 2013 Designed for Neuro Gait Training for SCI, CVA, TBI and other neuro diagnosis Improved stability at ankle and foot for more confident stance and faster gait Ability to free hip rotation and abduction for high level patients Ability to free ankle plantarflexion/dorsiflexion if strength permits Quicker hip/thigh adjustments for fast patient turnaround Weightshift assist at footplate 11

12 Gail F Forrest, Ph.D., Assistant Director, Human Performance and Engineering Laboratory (HPEL). Kessler Institute for Rehabilitation Presented at the annual Conference of SCI Professionals (ASCIP) September, patients (12 paraplegia, 1 tetraplegia) participated in the trials Exoskeleton Research Review Walking and standing in Ekso is feasible for people with a range of spinal cord disorders. It takes a bit longer for higher injuries to learn how to use Ekso. There were positive results in function with training in the Ekso on: Walking speed and distance, fluidity, gait and balance. For two individuals we evaluated the potential benefits for heart, lungs and circulation. There were increases in oxygen consumption and ventilation. By comparing an experienced walker (30 sessions) with a novice there was evidence of a training effect. The experienced user s oxygen consumption, ventilation and heart rate returned to baseline resting values faster. There was also noted increased muscle firing in lower leg muscles and this will need to be studied further. Stephanie A. Kolakowsky-Hayner PhD, CBIST, Director of Rehabilitation Research Rehabilitation Research Center Santa Clara Valley Medical Center On August 28, 2012, SCVMC reported the results of their first study on Ekso related to the safety of the device. The results were presented at the Paralyzed Veterans of America conference and at the annual scientific meeting of the International Spinal Cord Society in London. Among the findings were: 8 patients were included in the research (all within 2 years of injury) Bionic exoskeletons can enhance mobility in those without volitional lower extremity function. The Ekso suit is safe for those with a thoracic SCI Use of an overhead tether should be considered (3 falls where tether came into play) There appears to be a training effect with the device No major skin effects and no pain reports No adverse events were reported Miami Project Mark Nash, PhD Professor, Neurological Surgery, Rehabilitation Medicine, and Kinesiology & Sport Science Miami Project is assessing over ground bionic ambulation (OBA) condition effects on cardiorespiratory endurance and the energy demands of steady state OBA. They area also assessing the OBA condition effects on biomarkers of SCI-specific cardio endocrine risk, assisting the functional utility and kinematic responses to OBA and examine how conditioning alters them, quantifying cortical activation during OBA and determining if changes in activation are associated with conditioning improvements for walking function, mobility, balance and fitness enhancements, and assessing OBA conditioning enhancements on life satisfaction, psychological well-being. 50 week project with various milestones and complicated outcome measures Pilot Study (Q1 2013) with preliminary results examining a range of benefits while walking in the Ekso bionic exoskeleton. Most obvious for us in conducting the research was the limited amount of energy needed by individuals with chronic SCI to walk in the brace, making the device a serious candidate for use as a mobility device. In this respect, the prosthesis is the first to allow functional ambulation without rapid exhaustion by the user. Moreover, individuals with SCI who walked in the brace self-reported reduction in their habitual musculoskeletal pain, and a lessening of lower extremity muscle spasms. We are currently submitting these findings to a peer-review journal, and are in the midst of planning the second generation of our studies. RIC Preliminary Results Rehabilitation Institute Of Chicago Arun Jayaraman, PT, Phd, Et Al. Center For Bionic Medicine And Department Of Physical Medicine And Rehabilitation The Rehabilitation Institute of Chicago presented their preliminary results at the 2013 ASIA conference. Their goals were to identify the clinical criteria for safe and efficient use of exoskeletons in individuals with SCI, develop training strategies for independent over-ground ambulation of individuals with SCI in a clinical setting, and develop training strategies to allow independent ambulation of individuals with SCI at home and in the community. ReWalk Data: Spungen, et al currently enrolled (C6-L4, complete) in 12 week study, 2 visits/week Some participants walk faster, but seem to have less balance; some participants walk slower, but have better balance Six-weeks of training seems to be a stable point Larger numbers needed to predict proficiency which includes different levels of injury, ROM, patient reported and performance-balanced tests 12

13 Indego: Goldfarb, Hartigan et, al So, where are we going? More research in all areas Preliminary results favorable Rehabilitation Stairs/Ramps/Curbs Improved turning and stability Increased degrees of freedom at hip Variable assist in stance and with sit to stands Lighter More functional Better battery life Stable and safe outdoors on varied terrain PT/spotter not required Affordable Personal Ability to carry items? Fit in WC or drive in suit Conclusion Exoskeletons are gaining momentum Technology is advancing quickly Research is underway and initially favorable Rehab clinicians should be aware of the technology and as patients will be asking questions 13

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