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An exoskeleton is an external structure with joints and links that might be regarded as wearable robots designed around the shape and function of the human body. A powered exoskeleton consists of an exoskeleton-like framework worn by a person that includes a power source supplying energy for limb movement. The goal of the powered exoskeleton in the lower extremities is to enable people who do not have volitional movement of their lower extremities to bear weight fully while standing, to ambulate over ground, and to ascend and descend stairs. The goal of the powered exoskeleton in the upper extremities is to assist in the assessment and treatment of upper body movement impairments. Use of the powered exoskeleton has been proposed for patients with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barre’ syndrome, cerebral palsy, spina bifida, musculoskeletal disease, and neurologic injury.
The ReWalk™ (ReWalk Robotics, previously Argo Medical Technologies) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) in 2014. ReWalk™ is an external, powered, motorized orthosis (powered exoskeleton) that is placed over a person’s paralyzed or weakened lower limbs to provide ambulation. The FDA is requiring ReWalk’s manufacturer to complete a postmarket clinical study to collect data on adverse events related to the use of the device and prospectively and systematically assess the adequacy of its training program.
The ReWalk™ is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports, stair climbing, uneven surfaces such as sandy or stony areas, or on any surface that is not appropriate for crutches.
The ReWalk ReStore™ was FDA cleared for marketing in 2019 and is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance.
The Ekso™ and Ekso™ GT exoskeletons (Ekso Bionics) were cleared for marketing in 2016 to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist. The devices are intended for use in patients with stroke-initiated hemiplegia, spinal cord injuries at levels T4 to L5, or spinal cord injuries at T3 to C7. The device is not intended for sports or stair climbing.
In 2016, the Indego® powered exoskeleton (Parker Hannifin), was cleared for marketing by the FDA through the 510(k) process as substantially equivalent to the ReWalk as a predicate device. Indego® is “intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion.” It has also received marketing clearance for use in rehabilitation institutions.
In 2017, HAL for Medical Use (Lower Limb Type) (CYBERDYNE Inc.) was cleared for marketing by the FDA through the 510(k) process (K171909). The ReWalk™ was the predicate device. The HAL is intended to be used inside medical facilities while under trained medical supervision for individuals with spinal cord injury at levels C4 to L5.
In 2017, the FDA approved the Wilmington robotic exoskeleton (WREX) (JAECO Orthopedic) as a class I medical device. The WREX is a passive, body-powered, antigravity arm orthosis designed to enhance movement for individuals with neuromuscular disabilities of the upper extremity. Modifications to the WREX include the now commercialized Armeo Spring, formerly known as the Therapy Wilmington Robotic Exoskeleton (T-WREX) (Biorobotics Laboratory). The FDA classifies the Armeo Spring as a Class II device. This device is aimed at those with weakened hands, to practice using their hands in a virtual world via computer games with simulated movements.
In 2019, Ekso Bionics Holdings, Inc announced the EksoUE, an upper extremity rehabilitation device. The wearable upper body exoskeleton is put on similar to a jacket, secured at the waist, and on the arms and wrists. Lift assistance is provided by passive mechanisms located on the arms. EksoUE is registered with the FDA as a class I medical device.
In 2020, the FDA approved the Abilitech® Assist (Abilitech Medical) as a class I medical device. The Abilitech® Assist is an arm support device developed for patients with arm weakness or injury, specifically neuromuscular weakness, to complete activities of daily living. The device provides a hybrid assist at the shoulder and elbow and includes springs at the shoulder and elbow and a connected battery pack to assist with movement.
Note: Non-powered or dynamic support devices are not addressed in this policy. Please refer to policy VII-04 Wheelchairs-Mobility Assistive Equipment.
Use of a powered exoskeleton is considered EXPERIMENTAL/INVESTIGATIVE for all indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
E0739 E1399 K1007 L3999
No additional statements.
Summary of Evidence
For individuals who have lower-limb disabilities who receive a powered exoskeleton, the evidence is limited to small studies performed in institutional settings with patients who have spinal cord injury. No studies of device use in a community or home setting have been reported. A 2016 report from the Veterans Administration has suggested that over 60 training sessions may be needed to achieve proficiency with both indoor and outdoor mobility, including door/threshold navigation, stopping, turning, and reaching. An attendant must also be trained to assist the exoskeleton user. There are concerns about the safety of these devices under regular use, including the potential to trip and fall. Further study is needed to determine whether these devices can be successfully used outside of the institutional setting.
Rationale
Pre-post study designs are most likely to provide evidence on the effects of a powered exoskeleton on health outcomes. Outcomes of interest are the safety of the device, the effect of the exoskeleton on the ability to ambulate, and the downstream effect of ambulation on other health outcomes (eg, bowel and bladder function, spasticity, cardiovascular health). Of importance in this severely disabled population is the impact of this technology on activities of daily living, which can promote independence and improved quality of life. Issues that need to be assessed include the device’s performance over the longer term when walking compared to wheelchair mobility, the user’s usual locomotion outside of the laboratory setting, and the use of different exoskeletons or the training context. Adverse events (eg, falling, tripping) can impact both safety and psychological security, and also need to be assessed.
There is limited information about the use of ReWalk outside of the institutional setting. Several small series have been identified for ReWalk in an institutional setting. Standard measures of walking function include the Timed Up and Go (TUG) test, which assesses the time required to get up from a chair and commence walking, the 10-meter walk test (10MWT), which evaluates the time required to walk 10 meters, and the 6-minute walk test (6MWT), which measures the distance walked in 6 minutes.
A multicenter evaluation of performance with the ReWalk in 24 individuals with spinal cord injury (SCI) was included in the device application to the U.S. Food and Drug Administration. Screening criteria included complete motor cervical (C7-C8) or thoracic (T1-T12) SCI; age between 18 and 55 years; regular use of a reciprocating gait orthosis, knee-ankle-foot orthosis, or standing device; height between 160 to 190 cm, and weight less than 100 kg. Study participants received 16 to 24 training sessions of 60 to 90 minutes in duration over the course of about 8 weeks. The primary outcome measures were distance on the 10MWT and the 6MWT. Results for the 6MWT were available for 20 participants, who walked for a range of 0 to over 100 meters in 6 minutes. For the 10MWT, 22 of the 24 participants required between 10 to more than 100 seconds to walk 10 meters.
In 2012, Esquenazi et al published a safety and efficacy trial of the ReWalk in 12 subjects with motor-complete thoracic SCI. All had lower-limb bone and joint integrity, adequate joint range of motion, and a history of standing (either with lower-limb bracing or a standing frame) on a frequent basis. Over 8 weeks, subjects received up to 24 sessions of training lasting 60 to 90 minutes per session that included stepping, sit-to-stand, standing, and stand-to-sit transfers. During this time, unsupervised use of the exoskeleton was not allowed. All 12 participants completed training and were able to independently transfer and walk for at least 50 to 100 meters for a period of at least 5 to 10 minutes. Participants did occasionally lose their balance and either caught themselves with their crutches or were stabilized by the physical therapist. With monitoring of walking, there were no serious adverse events such as falls, bone fractures, or episodes of autonomic dysreflexia. Self-reported health benefits collected at the end of training from 11 subjects included reduced spasticity (n=3) and improved bowel regulation (n=5).
A 2012 report by Zeilig et al describes a pilot study of ReWalk in 6 patients with SCIs. Study participants required an average of 13.7 training sessions, each lasting an average of 50 minutes, before they were able to complete the TUG, 10MWT, and 6MWT. The average distance walked in 6 minutes was 47 meters, which correlated highly with the level of the SCI. There were no falls or skin or joint injuries during testing, and following training, subjects reported that they felt safe and comfortable using the device. Blood pressure and pulse rates were within the range consistent with physical activity.
Bach Baunsgaard et al published results of a study of safety, feasibility and impact of the Ekso device on gait function conducted in 9 European rehabilitation centers. The study population of 52 participants was heterogenous with SCI at levels ranging from C1-L2 and severity of spinal injury using the American Spinal Injury Association (ASIA) Impairment Scale ranging from A (Complete) to D (motor function is preserved below the neurologic level). Time since injury (TSI) for 25 participants was < 1 year; 27 participants had time from SCI > 1 year. Median age was 35.8 years (27.5-52.5). No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Measures included 10MWT, TUG, Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS). Participants with gait function, all functions increased from 20 to 56% (p= 0.004) in patients with TSI < 1, and 10MWT, TUG, BBS and LEMS results improved (p< 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05).
The Indego powered exoskeleton was evaluated after 5 training sessions (lasting 1.5 hours each for 5 consecutive days) in 16 patients with SCI between C5 and L1. Testing included the 6MWT and 10MWT. Following training, patients with motor complete tetraplegia (C5-C7 injury level) were able to ambulate on indoor surfaces (hard flooring, carpet, and thresholds), outdoor surfaces (sidewalks), elevators, and ramps, using a walker with assistance from 1 or 2 therapists. In the group of patients with upper paraplegia (T1-T8 injury level), all were able to walk on indoor surfaces, outdoor surfaces, and in elevators; and most were successfully tested on ramps. Among the 8 patients with lower paraplegia (T9-L1 injury level), 6 were able to walk without assistance on indoor surfaces, outdoor surfaces, elevators, ramps, and grass, and 2 required minimal assistance from a therapist. No studies were identified that evaluated the Indego for distances further than 10 meters.
Van Dijsseldonk et al reported in a 2017 study that a framework to test exoskeleton skills is lacking. The aim of this study was to develop and test the hierarchy and reliability of a framework for measuring the progress in the ability to perform basic and advanced skills. Twelve participants with paraplegia were given 24 training sessions in 8 weeks with the Re-walk-exoskeleton. During the 2nd, 4th, and 6th training week the Intermediate-skills-test was performed consisting of 27 skills, measured in a hierarchical order of difficulty, until two skills were not achieved. When participants could walk independently, the final-skills-test, consisting of 20 skills, was performed in the last training session. Ten participants completed the training program. Their number of achieved intermediate skills was significantly different between baseline and completion of training (p = 0.001). Post-hoc analysis revealed a significant increase in the median achieved intermediate skills from 4 [1-7] at the first to 10.5 [5-26] at the third Intermediate-skills-test. The rate of participants who achieved the intermediate skills decreased and the coefficient of reproducibility was 0.98. Eight participants met the criteria to perform the Final-skills-test. Their median number of successfully performed final skills was 16.5 [13-20] and 17 [14-19] skills in the first and second time. The overall consistency of >70% was achieved in the Intermediate-skills-test (73%) and the Final-skills-test (81%). Eight out of twelve participants experienced skin damage during the training, in four participants this resulted in missed training sessions. The framework proposed in this study measured the progress in performing basic and advanced exoskeleton skills during a training program.
In 2016, investigators from the Department of Veterans Affairs (VA) reported on screening criteria, fitting, and training procedures for use of a powered exoskeleton. Skills practiced included standing, sitting, standing balance, progression with both indoor and outdoor walking, and tasks that included reaching, stopping, turning, and door/threshold navigation. Training sessions were conducted for 60 to 90 minutes, 3 times a week, with at least 60 training sessions per patient. A person is taught to ambulate in various environments ranging from indoor level surfaces to outdoors over uneven or changing surfaces. Once skilled enough to be a candidate for home use with the exoskeleton, the user is then required to designate a companion-walker who will train alongside them. Together, the pair must demonstrate the ability to perform various advanced tasks in order to be permitted to use the exoskeleton in their home/community environment. Authors concluded that standardization of a training program is needed to ensure participant safety, successful use of the device, identify staff resources, and to acquire consistent results
ECRI published an emerging technology evidence report on wearable powered exoskeleton use after spinal cord injury in 2017. The analysis assessed evidence from 10 short-term noncomparative studies on 2 devices used in rehabilitation centers; no studies assessed device use in the home/community setting. No studies compared the safety and effectiveness of a wearable powered exoskeleton and other strategies for gait training or therapeutic exercise in a rehabilitation setting or other assistive devices used to enable standing or mobility in the home/community setting. The assessment noted that the devices have not yet been in use long enough to gather long-term data. Nine studies provided adverse event (AE) data on 118 patients with SCI who received powered exoskeleton training in rehabilitation settings. The most commonly reported AEs were minor to moderate skin abrasions. No falls, pressure ulcers, joint injury, or dysreflexia were reported in these short-term studies. No studies reported on the safety of exoskeleton use by individuals in a home/community setting. ECRI grades strength of evidence based on the concepts and methods proposed by the GRADE working group using ratings of very low, low, moderate, and high. Based on the assessment of available literature, evidence grades were low for walking performance in rehabilitation setting (Measured by standard walking tests) and advanced walking skills in a rehabilitation setting (e.g., stairs, uneven surfaces, outdoor surfaces, ramps, sidewalks, grass, around obstacles, through doors). Evidence was graded as very low for effects on short-term quality of life.
The American Physical Therapy Association published guidelines in 2020 providing recommendations to guide improvement of locomotor function after brain injury, stroke, or incomplete spinal cord injury in ambulatory patients. The guidelines recommend against the use of powered exoskeletons for use on a treadmill or elliptical to improve walking speed or distance following acute-onset central nervous system injury in patients more than six months post-injury due to minimal benefit and increased costs and time. A 2022 article by Hohl et al comments on how this guideline recommendation adds uncertainty to the clinical application of powered exoskeletons in rehabilitation. Several studies referenced in the guideline did not use the US Food and Drug Administration (FDA)-approved devices discussed in this review; rather, the guideline focused on treadmill-based robots, specifically the Lokomat. Therefore, the conclusions should be interpreted with caution, given the substantial differences in functionality and physical demand between the treadmill-based robots and the powered exoskeletons of interest. Taking into consideration the limited guidance on proper use of powered exoskeletons, Hohl et al developed a framework for clinical utilization of powered exoskeletons in rehabilitation settings. The aims of the framework are to: 1) assist practitioners with clinical decision making of when exoskeleton use is clinically indicated, 2) help identify which device is most appropriate based on patient deficits and device characteristics, 3) provide guidance on dosage parameters within a plan of care, and 4) provide guidance for reflection following utilization. The framework focuses specifically on clinical application, not use of powered exoskeletons for personal mobility.
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