| Coverage Policy Manual | |
| Policy #: | 2014025 |
| Category: | DME |
| Initiated: | January 2015 |
| Last Review: | April 2024 |
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| Powered Exoskeleton for Ambulation in Patients with Lower Limb Disabilities | |
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| Description: |
The goal of the powered exoskeleton is to enable people who do not have volitional movement of their lower extremities to be able to fully bear weight while standing, to walk, and to navigate stairs. The devices have the potential to restore mobility and, thus, might improve functional status, quality of life, and health status for patients with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and spina bifida.
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, as described in this policy, consists of an exoskeleton-like framework worn by a person and a power source that supplies the energy for limb movement.
One type of powered lower-limb exoskeleton (ReWalk, Indego) provides user-initiated mobility based on postural information. Standing, walking, sitting, and stair up/down modes are determined by a mode selector on a wristband. ReWalk includes an array of sensors and proprietary algorithms that analyze body movements, such as tilt of the torso, and manipulate the motorized leg braces. The tilt sensor is used to signal the on-board computer when to take the next step. Patients using the powered exoskeleton must be able to use their hands and shoulders with forearm crutches or a walker to maintain balance. Instructions for walking with the ReWalk are to place the crutches ahead of the body and bend the elbows slightly, shifting weight toward the front leg, leaning toward the front leg side (Zeilig, 2012). The rear leg will lift slightly off of the ground and then begin to move forward. Using the crutches to straighten up will enable the rear leg to continue moving forward. The process is repeated with the other leg.
To move from a seated to standing position or vice versa, the desired movement is selected by the mode selector on the wrist. There is a 5-second delay to allow the individual to shift weight (forward for sit-to-stand and slightly backward for stand-to-sit) and to place their crutches in the correct position. If the user is not in an appropriate position, a safety mechanism will be triggered. Walking can only be enabled while standing, and the weight shift must be sufficient to move the tilt sensor and offload the back leg to allow it to swing forward. Continuous ambulation is accomplished by uninterrupted shifting onto the contralateral leg. The device can be switched to standing either via the mode selector or by not shifting weight laterally for 2 seconds, which triggers the safety mechanism to stop walking. Some patients have become proficient with ReWalk by the third week of training (Asselin, 2015).
REGULATORY STATUS
In 2014, ReWalk™ (ReWalk Robotics, previously Argo Medical Technologies) was granted a de novo 510(k) classification (K131798) by the FDA (Class II; FDA product code; PHL). The new classification applies to this device and substantially equivalent devices of this generic type. ReWalk™ (current version ReWalk Personal 6.0) is the first external, powered, motorized orthosis (powered exoskeleton) used for medical purposes that is placed over a person’s paralyzed or weakened limbs for the purpose of providing ambulation. De novo classification allows novel products with moderate- or low-risk profiles and without predicates which would ordinarily require premarket approval as a class III device to be down-classified in an expedited manner and brought to market with a special control as a class II device.
The Argo ReWalk™ is intended to enable individuals with spinal cord injury at levels T7to 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 or stair climbing.
Candidates for the device should have the following characteristics:
In 2019, the ReWalk ReStore™, a lightweight, wearable, exo-suit, was approved for rehabilitation of individuals with lower limb disabilities due to stroke.
In 2016, Indego® (Parker Hannifin) was cleared for marketing by the FDA through the 510(k) process (K152416). The FDA determined that this device was substantially equivalent to existing devices, citing 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.” Indego® has also received marketing clearance for use in rehabilitation institutions.
In 2016, Ekso™ and Ekso GT™ (Ekso Bionics® Inc) were cleared for marketing by the FDA through the 510(k) process (K143690). The ReWalk™ was the predicate device. Ekso is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations with upper extremity motor function of at least 4/5 in both arms: individuals with hemiplegia due to stroke; individuals with spinal cord injuries at levels T4 to L5; individuals with spinal cord injuries at levels of C7 to T3.
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 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B)
In 2020, Keeogo™ (B-Temia) exoskeleton was cleared for marketing by the FDA through the 510(k) process (K201539). The Honda Walking Assist Device was the predicate device. Keeogo is intended for use in stroke patients in rehabilitation settings.
In 2021, ExoAtlet-II® (ExoAtlet Asia Co. Ltd.) was cleared for marketing by the FDA through the 510(k) process (K201473). The Ekso/Ekso GT was the predicate device. ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations with upper extremity motor function of at least 4/5 in both arms: individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of C7 to T3 (ASIA D).
In 2022, GEMS-H® (Samsung Electronics Co. Ltd.) was cleared for marketing by the FDA through the 510(k) process (K213452). The Honda Walking Assist Device was the predicate device. GEMS-H is intended to help assist ambulatory function in rehabilitation institutions under the supervision of a trained healthcare professional for individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of 1 person.
In 2022, EksoNR™ (Ekso Bionics Inc) was cleared for marketing by the FDA through the 510(k) process (K220988). EksoNR is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: individuals with multiple sclerosis (upper extremity motor function of at least 4/5 in at least 1 arm); individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least 1 arm); individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms), and individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
In 2022, Atalante® (Wandercraft SAS) was cleared for marketing by the FDA through the 510(k) process (K221859). The Indego was the predicate device. Atalante is intended to enable individuals (>18 years of age, able to tolerate a stand-up position) with hemiplegia due to cerebrovascular accident to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA product code: PHL
Coding
There was no specific code for these devices prior to 10/1/2020. HCPCS code K1007 [Bilateral hip, knee, ankle, foot device, powered, includes pelvic component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors] was added effective 10/1/2020.
An unlisted HCPCS code such as E1399 may also be reported.
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Policy/ Coverage: |
Effective January 2015
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Use of powered exoskeleton for ambulation in patients with lower limb disabilities does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of powered exoskeleton for ambulation in patients with lower limb disabilities is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy was created with a search of the MEDLINE database through November 11, 2014. Although the optimal study design for a therapeutic intervention is a randomized controlled trial, it is recognized that controlled trials in this population are unlikely to be performed. Studies that use a pre-post design may contribute to an understanding of 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 such as bowel and bladder function, spasticity, and 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.
Several small series have been identified for the ReWalk™. A study included in the FDA application was a multicenter evaluation of performance with the ReWalk™ in 24 individuals with spinal cord injury (FDA, 2014). Screening criteria included complete motor cervical (C7-C8) or thoracic (T1-T12) spinal cord injury, 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. The participants received 16 to 24 training sessions of 60 to 90 minutes over the course of about 8 weeks. The primary outcome measures were the 10-meter walk test (10MWT) and the 6-min walk test (6MWT). Results for the 6MWT were available for 20 participants, who walked for a range of 0 meters to over 100 meters in 6 minutes. Twenty-two of the 24 participants required between 10 and more than 100 seconds to walk 10 meters.
In 2012, Esquenazi et al published a safety and efficacy trial of the ReWalk in 12 participants with motor-complete thoracic spinal cord injury (Esquenazi, 2012). The patients in this report had lower limb bone and joint integrity, adequate range-of-joint motion, and a history of standing (either with lower limb bracing or a standing frame) on a frequent basis. The participants had training that included stepping, sit-to-stand, standing, and stand-to-sit transfers in up to 24 sessions of 60- to 90-min over a period of 8 weeks. The participants were not allowed to use the device unsupervised. All 12 participants who completed training in this study were able to independently transfer and walk for at least 50 to 100 min for a period of at least 5 to 10 min. 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 dysregulation. Self-reported health benefits at the end of training included improved spasticity (n=3) and bowel regulation (n=5).
A 2012 report by Zeilig et al describes a pilot study of the ReWalk™ in 6 patients with spinal cord injuries (Zeilig, 2012). The participants required an average of 13.7 training sessions to be able to complete the Timed Up and Go (TUG) test, 10MWT, and 6MWT. The average distance walked in 6 minutes was 47 min, and was highly correlated with the level of the spinal cord injury. There were no falls or skin or joint injuries. Blood pressure and pulse rate were within normal range for physical activity. The subjects reported that they felt safe and comfortable with the device.
Ongoing and Unpublished Clinical Trials
An online search of ClinicalTrials.gov in November 2014 found a number of trials on the ReWalk™ and Ekso™ systems, including the following:
Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI (VA_ReWalk2) NCT02118194 The overall goal of this project is to determine if nonambulatory persons with spinal cord injury who have already participated in at least 20 sessions of ReWalk training can be further trained to achieve more advanced skills for use in the home or work place environments and outdoor community mobility skills. The walking tests (10 MWT, 6-MWT, TUG) will be performed indoors on tile/linoleum and carpet and outdoors on concrete, asphalt, grass, dirt, uneven surfaces, curbs, curb cutouts, and ramps. The advanced indoor standing skills include countertop work, retrieving items from an overhead cabinet and from a refrigerator. The door navigation skills include a push button door, elevator doors, revolving doors, and nonpowered doors. The study has an estimated enrollment of 40 participants. Study completion is expected September 2017.
Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation (NCT02104622) This is a Phase II study sponsored by the Rehabilitation Institute of Chicago that will examine the potential of the ReWalk™ for everyday use, including ramps, stairs, curbs and indoor and outdoor use. The primary outcome measures include measurements of gait over ground and ability to negotiate stairs, ramps, curbs, and turning and the distance able to reach while standing and sitting. Secondary outcome measures include patient perception of quality of life, the Psychosocial Impact of Assistive Devices Scale, Activities-specific Balance Confidence Scale, Self-reported Spinal Cord Independence Measure in activities of daily living, and pain measured with a visual analog scale. The study has a targeted enrollment of 20 participants with completion expected September 2017.
EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With SCI (Spinal Cord Injury, NCT01701388) This is a Phase I study sponsored by the Rehabilitation Institute of Chicago. This study seeks to test the safety and efficacy of the Ekso™ device in spinal cord injury population and in populations with similar neurological weakness to the SCI population. The study is currently recruiting patients with spinal cord injury or similar neurologic weakness and has a target enrollment of 40 participants. Study completion is expected in April 2017.
Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO). (ROBOSCIEKSO, NCT02065830) The aim of this study will be to evaluate the safety and the efficacy of the Ekso™ device in subjects with spinal cord injury and in subjects with other neurologic disease with an impairment of lower limbs. The study has an estimated enrollment of 30 participants; recruitment had not started as of July 2014. Study completion is expected in March 2016.
Performance Attributes and User Progression While Using EKSO (NCT02132702) This industry-sponsored study will evaluate the performance attributes and user progression of participants with motor complete and incomplete SCI while utilizing the Ekso™ robotic exoskeleton in an 8-week overground, locomotor program. Secondary outcome measures will assess the cardiovascular effect, spasticity, strength, bladder and bowel function, functional abilities, gait, balance, and quality of life. This study is not yet open for recruitment. Completion is expected January 2017.
In summary at the present time, evaluation of the powered exoskeleton outside of the rehabilitation setting is limited to small studies performed in the laboratory setting. These studies have assessed the user’s ability to perform, under close supervision, standard tasks such as TUG, 6MWT and 10MWT. An occasional loss of balance has been noted, raising concerns about the safety of the device under regular use. Further study is needed to determine whether these devices can be successfully used outside of the investigational (laboratory) setting. .
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
The Indego powered exoskeleton was evaluated after 5 training sessions (lasting 1.5 hours each for 5 consecutive days) in 16 patients with spinal cord injury between C5 and L1 (Hartigan, 2015). Testing included the 6MWT and 10MWT. Following training, 3 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 in compliance with the Americans with Disabilities Act, using a walker with assistance from 1 or 2 therapists. In the group of 5 patients with upper paraplegia (T1-T8 injury level) 2 walked with supervision and 3 required only minimal assistance from a therapist. All of the patients in this group were able to walk on indoor surfaces, outdoor surfaces, and in elevators; 4 of 5 were successfully tested on ramps. Among the 8 patients with lower paraplegia (T9-L1 injury level) who were evaluated, 4 used a rolling walker and 4 used forearm crutches. After training for 5 days, 6 of the 8 were able to walk without assistance and 2 required minimal assistance from a therapist. Six were able to ambulate on indoor surfaces, outdoor surfaces, elevators, ramps, and grass. No studies were identified that evaluated the Indego for durations longer than the 10MWT, and the device is not yet cleared for marketing in the United States.
2017 Update
A literature search conducted using the MEDLINE database through November 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through September 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
A literature search was conducted through September 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A systematic review by Tamburella et al qualitatively summarized the effects of the powered exoskeleton (Ekso, ReWalk, Indego, REX, or HAL) on walking and on secondary health outcomes in patients with spinal cord injury (Tamburella, 2022). A total of 41 studies (566 patients) were included, of which only 1 was an RCT. The average patient age was 43.58 ± 7.84 years. The study assessed the effects of the powered exoskeleton on 14 domains: walking, cardiorespiratory/metabolic responses, spasticity, balance, quality of life, human-robot interaction, robot data, bowel functionality, strength, activities of daily living, neurophysiology, sensory function, bladder functionality, and body composition/bone density. The effects of Ekso, ReWalk, Indego, REX, and HAL were analyzed in 20, 14, 4, 2, and 1 studies, respectively. Of the 41 studies, 13 reported different adverse events during training with Ekso (n=5 studies), ReWalk (n=5), Indego (n=2), and HAL (n=1). The most frequent adverse events were skin lesions, while the less frequent adverse events were extreme fatigue, falls, bone fractures, or muscle strain. The average total number of sessions across the studies ranged from 1 to 55, and 42% of studies performed 3 sessions per week. Only 2 studies (both on Ekso) compared powered exoskeleton with other interventions (i.e., conventional physical therapy). In the studies that reported follow-up, follow-up examinations were performed 4 weeks after the end of treatment (n=3); or after 2 months (n=1), 2 to 3 months (n=1), and 12 to 15 months (n=1). Most studies used outcome measures relating to the walking domain; walking velocity was measured per the 10-meter walking test in 18 studies and the 6-minute walk test in 13 studies. For each domain, the systematic review reported the data as "significant" if the authors of each included study reported significant changes in their published data. A major limitation of the systematic review was that all included studies were of moderate or low methodological quality level, mainly due to poor study design. Other limitations included the small, heterogeneous number of participants; variable dosage of interventions; the absence of control groups and/or follow-up assessments in many studies; and the various parameters adopted in each domain for different types of comparisons. The heterogeneity of outcome measures precluded the ability to make general conclusions on the effects of powered exoskeletons.
An RCT (The Veterans Health Administration Cooperative Studies Program: Powered Exoskeletons for Persons with Spinal Cord Injury [PEPSCI] Trial) was designed for the study of exoskeletal-assisted walking in the home and community environments in patients with chronic spinal cord injury (Spungen, 2020). Of 424 enrolled patients, 263 failed screening and were not randomized. Of the 161 randomized patients, 151 (93.8%) were male; the mean age (standard deviation) was 46.2 (13.4) years. The intervention group consisted of standard of care (wheelchair for mobility) and use of ReWalk 6.0 exoskeleton at home for 4 months, while the control group consisted of standard of care (wheelchair) only. The primary aims of the study were to demonstrate clinically meaningful net improvements in the Mental Component Summary of the Veterans Rand-36 (MCS/VR-36) and in patient-reported outcomes for the Spinal Cord Injury Quality of Life (SCI-QOL) assessment tool for the physical-medical health domain components of bladder, bowel, and pain item banks. The major secondary aim was to demonstrate a reduction in total body fat mass. Study results have not been published and were obtained from ClinicalTrials.gov (NCT02658656). Limitations of the RCT include extensive exclusion criteria (resulting in several patients failing the screening process); furthermore, the use of an exoskeleton as an intervention prevented the ability for single- or double-blinding.
A 2022 article by Hohl et al comments on how this guideline recommendation adds uncertainty to the clinical application of powered exoskeletons in rehabilitation (Hohl, 2022). Several studies referenced in the guideline did not use the 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.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Asselin P, Knezevic S, Kornfeld S, et al.(2015) Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-158. PMID 26230182 Asselin PK, Avedissian M, Knezevic S, et al.(2016) Training persons with spinal cord injury to ambulate using a powered exoskeleton. J Vis Exp. Jun 16 2016(112). PMID 27340808 Asselin PM Cimigliaro CM, Kornfeld S, Knezevic S, et al.(2021) Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Archives of Physical Medicine and Rehabilitation. 2021;102(2):196-202. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2020.07.018. (https://www.sciencedirect.com/science/article/pii/S0003999320312223). Dijkers MP, Akers KG, Dieffenbach S, Galen SS.(2021) Systematic Reviews of Clinical Benefits of Exoskeleton Use for Gait and Mobility in Neurologic Disorders: A Tertiary Study. Archives of Physical Medicine and Rehabilitation, 2021;102(102):300-313. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2019.01.025. (https://www.sciencedirect.com/science/article/pii/S0003999319301522) Druzbicki M, Guzik A, Przysada G, Perenc L, et al.(2021) Effects of Robotic Exoskeleton-Aided Gait Training in the Strength, Body Balance, and Walking Speed in Individuals With Multiple Sclerosis: A Single-Group Preliminary Study. Archives of Physical Medicine and Rehabilitation, 2021;102(2): Pages 175-184. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2020.10.122. (https://www.sciencedirect.com/science/article/pii/S0003999320312247). Ehrlich-Jones L, Crown DS, Kinnett-Hopkins D, Field-Fote E, et al.(2021) Clinician Perceptions of Robotic Exoskeletons for Locomotor Training After Spinal Cord Injury: A Qualitative Approach. Archives of Physical Medicine and Rehabilitation, 202;102(2):203-215. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2020.08.024. Esquenazi A, Talaty M, Packel A, et al.(2012) The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. Nov 2012;91(11):911-921. PMID 23085703 Hartigan C, Kandilakis C, Dalley S, et al.(2015) Mobility Outcomes Following Five Training Sessions with a Powered Exoskeleton. Top Spinal Cord Inj Rehabil. Spring 2015;21(2):93-99. PMID 26364278 Hohl K, Giffhorn M., Jackson S, et al.(2022) A framework for clinical utilization of robotic exoskeletons in rehabilitation. J NeuroEngineering Rehabil. 2022:19(1). Article number 115. Kandilakis C, Sasso-Lance E.(2021) Exoskeletons for Personal Use After Spinal Cord Injury. Archives of Physical Medicine and Rehabilitation. 2021;102(2):331-337. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2019.05.028. (https://www.sciencedirect.com/science/article/pii/S000399931930396X). Knezevic S, Asselin PK, Cirnigliaro CM, Kornfeld S, et al.(2021) Oxygen Uptake During Exoskeletal-Assisted Walking in Persons With Paraplegia. Archives of Physical Medicine and Rehabilitation. 2021:102(2):185-195. ISSN 0003-9993, https://doi.org/10.1016/j.apmr.2020.08.025. (https://www.sciencedirect.com/science/article/pii/S0003999320312235). Lajeunesse V, Vincent C, Routhier F, et al.(2015) Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Disabil Rehabil Assist Technol. Sep 4 2015:1-13. PMID 26340538 Spungen AM, Bauman WA, Biswas K, et al.(2020) The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury. Contemp Clin Trials. Sep 2020; 96: 106102. PMID 32800962 Tamburella F, Lorusso M, Tramontano M, et al.(2022) Overground robotic training effects on walking and secondary health conditions in individuals with spinal cord injury: systematic review. J Neuroeng Rehabil. Mar 15 2022; 19(1): 27. PMID 35292044 U.S. Food and Drug Administration (FDA).(2014) Evaluation of automatic class III designation (de novo) for Argo ReWalk 2014; http://www.accessdata.fda.gov/cdrh_docs/reviews/K131798.pdf. Accessed November 21, 2014. Zeilig G, Weingarden H, Zwecker M, et al.(2012) Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. Mar 2012;35(2):96-101. PMID 22333043 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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