Disclosure. Esquenazi

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2 Learning Objectives At the conclusion of this activity, the participant will be able to: A. Understand the purpose and function of the ReWalk exoskeletal orthotic device. B. Understand the variation in walking distance and walking speed in the test population. C. Recognize the similarities and differences in joint mobility in the lower extremities during gait analysis

3 Disclosure I am an employee of MossRehab MossRehab has received some research funds from Argo Medica The funds do not pay for my salary or cover my time in this project, that is funded by the MossRehab research fund

4 Rosie the Jetson s Robot Karel Copck introduce the word Robot in 1921 from the Czech word robota meaning compulsory labor A.

5 Car assembly A.

6 Recreation A.

7 Function A.

8 Robotic assistance Honda Asimo A.

9 Powered Assist Exoskeletons

10 Powered Assist Exoskeletons

11 Introduction Few conditions are as disabling to the individual and society as SCI causing paralysis. Loss of motor control, respiratory disturbances, incontinence, movement disorders and pain are among the main consequences of this injury. Paralysis can lead to complications including: Deep vein thrombosis (DVT) Pressure ulcers Osteoporosis and Fractures Spasticity Weight gain

12 Introduction The restoration of walking in paraplegic patients is physiologically, psychologically, and functionally desirable.

13 Mobility and standing tools

14 Orthosis

15 ReWalk was conceptually developed by Amit Gopher PhD now president of ARGO Medica based in Haifa, Israel

16 Introduction ReWalk is a unique exoskeletal robotic assistive device that utilizes the user's body language to control externally powered gait.

17 ReWalk Powered Exoskeleton First exoskeleton device designed specifically to address the needs of individuals with SCI related lower limb paralysis

18 ReWalk ReWalk is a reciprocating active gait orthosis with powered hip and knee joints. The 4 independent joint motors have a microprocessor controlled stepping pattern, with subject controlled cadence. The ReWalk is specifically adjusted to closely match the patients limb lengths and pelvic width. Velcro secured straps (chest, abdomen, upper & lower thigh, upper calf and foot/ankle) secure the patient into ReWalk.

19 Person Machine Interface ReWalk is subject controlled for transfers, gait initiation, cadence, turning and when to stop. ReWalk is worn over clothing, there is no direct attachment between the system and the user ReWalk provides a unique person-machine interface that is patient calibrated

20 ReWalk Trial at MossRehab An ongoing study was designed to assess the safety, tolerance and ease of use of the ReWalk system Secondary outcome measures were tests of gait performance

21 ReWalk Trial Open, non comparative, non randomized study of safety and performance. Before and during each session the patient are evaluated for pain and fatigue Ashworth, blood pressure & pulse, and any abnormal skin, muscle or bone conditions are documented

22 ReWalk Inclusion Complete ASIA cervical (C7-C8) or thoracic (T1-T12) spinal cord injury Male and nonpregnant, nonlactating female Age 18 to 55 At least 6 months after injury

23 ReWalk Inclusion Regular use of a standing device or braces Capable of providing informed consent Height from 5'3" to 6'3" (160 to 190 cm) Weight less than 240 pounds (110 kg)

24 ReWalk Exclusion Neurological injuries other than SCI (MS, CP, ALS, TBI) Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores Severe spasticity (Ashworth 4 or sustained clonus) Unstable spine or unhealed limb or pelvic fractures Significant contractures or heterotopic ossification that restricts motion Psychiatric or cognitive conditions that may interfere with the trial

25 ReWalk Powered Exoskeleton

26 ReWalk Powered Exoskeleton

27 ReWalk Powered Exoskeleton

28 Patient Demographics Participants Screened:12 men and 3 women Participants enrolled: 8 men and 3 women. 3 subjects had significant osteoporosis and one had hip flexion contractures > 40 degrees Level: T3-T12 motor-complete spinal cord injury Age: 18 55, mean 40.2 yrs. Time from injury: , mean 8 yrs.

29 ReWalk Powered Exoskeleton

30 Subject AT (T11)

31 Subject AT

32 Patient Demographics Subjects N=11 Age in years (Mean+ SD) Min Max Time from injury (Mean+ SD) Min Max Gender Female Male Level of Injury T3 T4 T6 T8 T10 T11 T12 Value # Patients

33 Preliminary Data Intervention: Up to 24 training sessions with ReWalk a reciprocating gait orthosis with powered hip and knee joints controlled by a microprocessor, with a subject-controlled stepping pattern.

34 Outcome Measures User satisfaction survey 6 minute walk test without assistance 10 meter walk test without assistance Sit to stand and stand to sit abilities Instrumented Gait Analysis

35 Preliminary Data on 9 Subjects Preliminary Data on 10 Subjects Two of the subjects (T4 and T8 levels) were much more limited in their walking ability Results: All subjects have been able to transfer sit-stand-sit and walk independently with crutches 6 minute walk distance ranged from 54.3 m m with a mean of 99.3 m. 10 meter walk ranged from 0:22 0:55 min, mean 0:33 0 min

36 Preliminary Data on 9 Subjects Preliminary Data on 10 Subjects Two of the subjects (T3 and T8 1 ) were much more limited in their walking ability *= min minute walk distance = meters Ten meter test = seconds * * T3 T4 T8 T8 T10 T10 T10 T11 T12 T10

37 Data with Additional 6 Subjects from a pilot trial in Israel (N=16) Results: All 16 subjects have been able to transfer sit-stand-sit and walk independently with crutches 6 minute walk distance ranged from 30 m -180 m. 10 meter walk ranged from 0:22 1:27 min G. Zeilig, A Levy. Department of Neurological Rehabilitation,Sheba Medical Center, Tel Hashomer, Israel

38 Temporal-Spatial Parameters During ReWalk Walking of a trained subject

39 Preliminary Data Intervention: Up to 24 training sessions with ReWalk a reciprocating gait orthosis with powered hip and knee joints controlled by a microprocessor, with a subject-determined stepping pattern.

40 Preliminary Data

41 3D Sagittal Joint Angles During ReWalk Walking of a trained subject

42 Adverse Effects Superficial skin abrasions were the most common adverse effects from contact with the ReWalk, alleviated in all cases with revised/additional padding. One subject had orthostatic hypotension improved by elastic stockings and abdominal binder Two subjects had lower limb edema. No falls

43 MossRehab Preliminary Conclusions To date ReWalk enabled all the trained persons with complete motor thoracic-level spinal cord injuries to transfer and independently ambulate short distances using crutches for balance. The slower subjects appear to be hindered by reduced trunk control and inability to fully clear the foot during swing phase, resulting in short strides. Level of injury, spasticity and other factors not completely identified yet may have influenced this differences.

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45 Current Status Motors have been update to reduce noise and increase efficiency ReWalk-I is FDA approved for use in an institutional setting and is now available for clinical use in several facilities in the US and commercially available A ReWalk model for use at home will start trials in the Spring

46 Obtaining CME Credit If you would like to receive CME credit for this activity, please visit: This information can also be found in the Summit 2011 Program on page 8.

47 Thanks