An Update in Robotics in Outpatient Rehab. Kristen Black-Bain PT, DPT, NCS

Transcription

1 An Update in Robotics in Outpatient Rehab Kristen Black-Bain PT, DPT, NCS

2 Objectives Be familiar with various robotic devices for both upper and lower extremities. Be familiar with current research on various robotic devices for both upper and lower extremities. Learn about advances in exoskeleton development

3 If a robot does the robot, is it still called the robot? Or just dancing??

4 Robotics in Rehab Mobility aids Manipulation aids Evaluation tools Therapeutic aids

5 Repetition Interferenc e Specificity Transference Motor Learning Intensity Feedback Use it or Lose it Time Use it & Improve it

6 Robotics in Rehab Fewer therapists/staff Active participation with progression Reproducible Mental well being

7 Lower Extremity Robots

8 LE Robots Alter G Bionic Leg G-EO Lokomat Pro

9 Upper Extremity Robots

10 UE Robots ARMEO Power ReoGo InMotion ARM

11 Research Veterans Administration/Department of Defense, regarding UE robotics, recommend robot-assisted movement therapy as an adjunct to conventional therapy in patients with deficits in arm function to improve motor skill (Krebs, 2012). American Heart Association suggests that robot-assisted therapy for the UE has achieved Class I level of evidence for stroke care in outpatient and chronic care setting Class IIa for stroke care in inpatient setting (Krebs, 2012). Study of 10 chronic SCI (C4-C6) participating in 6 wk study showed clinically significant improvements in aim and smoothness of movement in UE kinematics (Cortes, 2013).

12 Research RCT; Subacute ( days) stroke patients; showed significant improvement in Fugl-Meyer, MAS, and PROM after robot-assisted upper limb rehab tx (Sale, 2014). Control group performing standard therapy also showed significant improvement in Fugl-Meyer but experimental group had higher improvement Single-blind RCT; children with CP improved significantly in manual dexterity assessed by Box and Block test compared with control group (Gilliaux, 2015). Single-blind RCT; chronic stroke patients had significant improvement in task-oriented arm training after six months (Timmermans, 2014)

13 Device Function Cost Features ARMEO Intelligent arm support in 3D workspace, 6 actuated DOF, augmented feedback, provides objective data $190,000 Pediatric option, more degrees of freedom Reo-Go 3D gyro mechanism; performance feedback, collects objective data $85,000 Mobile/easy to move; lock out specific motions InMotion 2 active DOF at shoulder; $110,000- ARM and Hand. Additional $90,000 for InMotion Wrist Optional InMotion Hand and Wrist for combined coordination of movement. Pediatric option

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17 Hybrid UE Robot Research MAHI-EXO II Upper extremity exoskeleton 5 degrees of freedom Hard stop at elbow Currently conducting validation studies for patients with Stroke and SCI MAHI-EXO II + BCI (Brain Computer Interface) Currently recruiting subacute and chronic stroke participants Photo courtesy of

18 Lower Extremity Exoskeletons

19 Exoskeletons ReWalk Ekso Rex

20 Ekso Formerly called E-Legs Wearable bionic suit that enables user to stand and walk over ground Battery powered motors move limbs in reciprocal gait pattern Progressing walking modes Training mode with audio feedback for appropriate weight shifting Variable assist Various settings that allow range of passive to actively assisted stepping from user Bilateral Max Assist Adaptive Assist Fixed Assist Photo courtesy of

21 Research Clinical trials out of Kessler showing positive results from training with Ekso exoskeleton (presented at ASCIP 2012, 2014 conference by Gail Forrest, PhD) Increased oxygen consumption, ventilation, and heart rate showing potential cardiovascular benefit Increased muscle firing in lower leg muscles during Ekso assisted walking Increase gait speed and decreased stance time on single limb with increased training Increased loading on LEs

22 Research Clinical trials out of Mount Sinai (presented at ASCIP 2014 by Allan Kozlowski, PT) Ekso walking is safe (no adverse events occurred) Level of assistance varies HR, RPE, METs comparable to light exercise Secondary benefits: reports of improved pain, spasticity, posture, sleep, and bowel function Psychosocial benefits

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24 Rex Bionics Hands free, self supported device controlled by joystick Can be used by people with cervical injuries as high as C-4 Can navigate up/down stairs and ramps Rehab and personal units available (UK only) Fast adjustability Update: Clinical trials starting in early 2015 Goal is to secure pre-market notification, 501(k) from FDA by end of second quarter of 2016 leading to at-home use late Photo courtesy of

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26 ReWalk Stepping is controlled by wt shifting and subtle trunk movements that trigger tilt sensors Adjustability for varying levels of user (beginner advanced) Joint range, step speed, delay between steps, tilt angle, current threshold Battery held in backpack Able to ascend/descend stairs Used with forearm crutches Mode is determined by watch controller worn by user Photo courtesy of Only FDA approved device in US for personal use

27 Research 6 Chronic SCI volunteer participants with thoracic level (T5- T12) complete injuries participated in average 13 training sessions did not show any increase in pain or adverse effects (Esquenazi, 2012) One participant with chronic high-level neuropathic pain (VAS 8-9) showed repeated improvement after training (VAS 4-6). In a nonrandomized single intervention trial, 12 subjects with chronic thoracic level (T3-T12) motor complete SCI reported positive emotional/psychological benefits on survey (Zeilig, 2012) 3/11 reported improved spasticity, 0/11 reported increase in pain, 5/11 reported improved bowel regulation

28 Research Improved bowel function in 5 motor complete SCI participating in sessions of ReWalk exoskeleton training (Fineberg, 2012) Decreased average time of evacuation reduction of dependency for manual stimulation, laxatives, or stool softeners Early data out of Bronx VA (Ann Spungen, presented at ASCIP 2014); 7 ReWalk users walking 1-2 hours 3 days a week Improved skill level (decreased assistance, varied terrain outdoors, community mobility) potential positive lean tissue mass changes in users with lower motor partial zones of preservation No changes in bone mineral density Loss of fat mass Report of significant improvement in bowel function Increased energy expenditure but sustainable Improved QOL

29 Case Report Female 27 years old; Chronic T-10 AIS-C SCI, 10 years post injury Goal: to walk around home with braces (KAFO/AFO) Previously attempted ambulation with braces and FWW Subjective report: required assistance, relied heavily on UEs allowing only 5-10 ft of gait with FWW Measurements before ReWalk training TUG: 52 sec; wearing R KAFO and L AFO in parallel bars LE MMT R hip flex 4-/5 L hip flex 4+/5 R hip ext 2-/5 L hip ext 3-/5 R knee ext 3-/5 L knee ext 5/5 R knee flex 2/5 L knee flex 3/5 Pain: daily nerve pain in B LEs L > R, worst 9/10 on VAS

30 Case Report Intervention 2-3 days/ week X 6 weeks 15 sessions total; 11 ReWalk, 4 gait training with braces started after first 3 weeks Measurements after 6 weeks TUG: sec (52.36 sec) Ambulate 77 (5-10) ft with FWW LE MMT R hip flex 4-/5 (4-) L hip flex 4+/5 (4+) R hip ext 2+/5 (2-) L hip ext 3-/5 (3-) R knee ext 3/5 (3-) L knee ext 5/5 R knee flex 2/5 (2) L knee flex 3+/5 (3) Pain: daily nerve pain in B LEs; worst 8/10 VAS (9/10)

31 When using the ReWalk I could feel my abs starting to work and I hadn t felt that before. Using it definitely helped with my sitting balance. Using the ReWalk has helped my trunk to get stronger with other things I do.

32 Hybrid-Exoskeletons Indego HAL Kinesis/H2

33 H2-Exo / Kinesis Exoskeleton developed by Technaid out of Spain Bilateral lower extremity equipped with active actuators at knee hinges Passive elastic actuators at ankles EMS: PC controlled stimulator delivers biphasic current to knee ext/flex Can manually trigger steps Wearer uses walker for UE support

34 Research Pilot study; 3 motor incomplete SCI using FES hybrid exoskeleton able to complete 6 minutes of walking after one day (Del Ama, May 2014) After only one week of training, improved gait measures (10m and 6MWT), but also continued to improved one week after intervention. HYPER project Recruiting for clinical trial: Subacute or chronic stroke patients

35 H2-Exo

36 Cyberdyne HAL Hybrid-Assistive-Limb World s First Cyborg type robot that interfaces man, machine, and information Assistance triggered by EMG from surface electrodes Single LE, Bilateral LE, or whole body UE/LE combo Currently only in Japan and Germany Submitted application for FDA clearance in U.S. Photo courtesy of

37 Research After 16 training sessions, patients with various neurological diagnoses (Stroke, SCI) improved gait speed, number of steps, and cadence (Kubota, 2013). HAL was found to be safe when used for gait training in acute stroke patients (Nilsson, 2014) All 7 participants improved gait measured by 10MWT

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39 Indego Lightweight at only 27 lbs Breaks down to smaller pieces for easy travel/transportation Functional electrical stimulation component Adapts to user input with varying levels of power provided Requires use of AFO to be worn with device Photo courtesy of

40 Indego Slim profile that allows sitting in most standard wheelchairs Wireless operation through app on mobile device Single handed strapping Not yet approved by FDA Commercial release expected in 2016 in US Photos courtesy of

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42 Research Single subject case study showed exoskeleton powered locomotion to have faster gait speed and also reduced exertion compared with KAFO use (Farris, 2013). Single subject case study with T10 complete SCI using exoskeleton combined with FES showed 34% reduction in electrical power required at hip joints during stance phase of gait (Ha, 2012)

43 Research Preliminary data presented at ASCIP 2014 Potential for multiple dxs (SCI, CVA, TBI, MS, etc) Easy to learn for staff and family/caregivers Self report of reduced spasticity during and up to 4 hrs after Reduced pain and time for bowel care Recruiting for multi center clinical trial

44 Device Function Cost Availability Ekso Indigo HAL, Cyberdyne ReWalk Rex Bionics Can balance indep, Sit to stand, gait, progressing level of independence settings E-stim, sit to stand, gait, stair climbing Sit to stand, gait, upper and lower limb assistance, Sit to stand, gait, direction change, stair climbing Sit to stand, gait, stairs, ramps up/down, no assistive device Rehab Unit: approx- $150,000 Projected estimate: approx- $30,000 Facility contract rental agreement: $5000 initial then approx- $1400-$1600 per mo Rehab Unit: approx- $85,000 Personal Unit: projected approx- $65,000 Both rehab and personal units: $150,000 Currently only rehab unit available. Expecting FDA approval 2016 Japan and Germany, has applied for FDA approval in US Currently rehab unit available. Available for purchase. VA has covered one P unit Rehab unit avail worldwide; Personal- UK

45 3D Printing Photo courtesy of

46 MindWalker Project Photo courtesy of

47 Walk Again

48 Criteria for Exoskeleton use Healthy weight Range of motion within normal limits Orthopedically stable Upright tolerance Device specific requirements Contraindications: - fractures, uncontrolled spasticity, pregnancy, skin breakdown, DVT, low blood pressure, psychiatric/cognitive issues, contractures

49 Good Physical Health is the Key!!

50 Considerations when choosing a device Patient population Cost How will it be used/ Reimbursement The company providing and manufacturing the device. Space/ceiling height in your facility

51 Repetition Interferenc e Specificity Transference Motor Learning Intensity Feedback Use it or Lose it Time Use it & Improve it

52 Be Creative! Think outside the box!

53 REFERENCES: Bishop L, Stein J, Wong CK. Robot-aided gait training in an individual with chronic spinal cord injury: a case study. JNPT. 2012;36: ( ). Byl NN. Mobility training using a bionic knee orthosis in patient in a post-stroke chronic state: a case series. Journ of Medical case report. 2012; 6:216. Cortes M, et al. Improved motor performance in chronic spinal cord injury following upper-limb robotic training. Neuro Rehabil. 2013; 33 (57-65). del-ama AJ, Gil-Agudo A, Pons JL, Morena JC. Hybrid FES-robot cooperative control of ambulatory gait rehabilitation exoskeleton. J Neuroeng Rehabil Mar 4; 11:27. del-ama AJ, Gil-Agudo A, Pons JL, Moreno JC. Hybrid gait training with an overground robot for people with incomplete spinal cord injury: a pilot study. Front Hum Neurosci May 13; 8:298. Esquenazi A, Packel A. Robotic-Assisted gait training and restoration. Am J Phys Med Rehabil. 2012; 91 (Suppl), Esquenazi A, Talaty M, Packel A, Saulino M; The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am Journ Phys Med Reh Nov; 91: 11 (911-21). Farris R, et al. A preliminary assessment of legged mobility provided by a lower limb exoskeleton for persons with paraplegia. IEEE Trans Neural Syst Rehabil Eng. 2013; 18. Fineberg DB, et al. Improvements in bowel function in paraplegics using ReWalk for overground ambulation. Poster presentation. Academy of spinal cord injury professionals. Annual conference Fineberg DB, Asselin P, Harel NY, Agranova-Breyter I, Kornfeld SD, Bauman WA, Spungen AM. Vertical ground reaction force-based analysis of powered exoskeleton-assisted walking in persons with motorcomplete paraplegia. Journ Spinal Cord Med. 2013, 36:4, Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, et al. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair Feb; 29(2):

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55 Nooijen CF, et al. Gait quality is improved by locomotor training in idividuals with SCI regardless of training approach. J Neuroeng Rehabil. 2009; 6:36. Norouzi-Gheidari N, et al. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. JRRD. 2012; 49:4 ( ). Sale P, et al. Robot-assisted walking training for individuals with Parkinson s disease: a pilot randomized controlled trial. BMC Neurol. 2013; 13: 50. Sale P, Franceschini M, Mazzoleni S, Palma E, Agosti M, Posteraro F. Effects of upper limb robotassisted therapy on motor recovery in subacute stroke patients. Journ Neuroeng and Rehabil. 2014, 11:104. Talaty M, Esquenazi A. Differentiating ability in users of the rewalk powered exoskeleton. IEEE Int Conf Rehabil Robot. Jun, 2013; 1-5. Tefertiller C. et al. Efficacy of rehabilitation robotics for walking training in neurological disorders: A review. Journ Rehabil Res & Dev. 2011; 48: Timmermas AA, Lemmens RJ, Monfrance M, Geers RP, Bakx W, Seelen HA. Effects of task-oriented robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized controlled trial. J Neuroeng Rehabil Mar 31;11:45. Toyo Keizai. Cyberdyne Inc.- the robot suit obtains certification in Europe. Translated from Ueraburu Tanmatsu mo Zokuzoku Tojo- Donaru Nihon no Denshibuhin. Weekly, Sept 2013: Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009; 6:18. Wirz M, et al. Effectiveness of automated locomotor training in patients with chronic incomplete spinal cord injury: a multicenter trial. Arch Phys Med Rehabil. 2005;86:4, Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training; a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012;36(1): Zeilig G, et al. Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. Journ of Spin Cord Med. 2012; 35:2.