Coverage Policy Manual
Policy #: 2010011
Category: DME
Initiated: March 2010
Last Review: December 2018
  Myoelectric Prosthetic and Orthotic Components for the Upper Limb

Description:
Upper-limb prostheses are used for amputations at any level, from the hand to the shoulder. The need for a prosthesis can occur for a number of reasons, including trauma, surgery, or congenital anomalies. The primary goals of the upper-limb prostheses are to restore function and natural appearance. Achieving these goals also requires sufficient comfort and ease of use for continued acceptance by the wearer. The difficulty of achieving these diverse goals with an upper-limb prosthesis increases with the level of amputation (digits, hand, wrist, elbow, shoulder), and thus the complexity of joint movement increases.
 
Upper limb prostheses are classified into 3 categories depending on the means of generating movement at the joints: passive, body-powered, and electrically powered movement. All 3 types of prostheses have been in use for over 30 years; each possesses unique advantages and disadvantages.
  • The passive prosthesis is the lightest of the three types and is described as the most comfortable. Since the passive prosthesis must be repositioned manually, typically by moving it with the opposite arm, and cannot restore function.
  • The body-powered prosthesis utilizes a body harness and cable system to provide functional manipulation of the elbow and hand. Voluntary movement of the shoulder and/or limb stump extends the cable and transmits the force to the terminal device. Prosthetic hand attachments, which may be claw-like devices that allow good grip strength and visual control of objects or latex-gloved devices that provide a more natural appearance at the expense of control, can be opened and closed by the cable system. Patient complaints with body-powered prostheses include harness discomfort, particularly the wear temperature, wire failure, and the unattractive appearance.
  •  Myoelectric prostheses use muscle activity from the remaining limb for the control of joint movement. Electromyographic (EMG) signals from the limb stump are detected by surface electrodes, amplified, and then processed by a controller to drive battery-powered motors that move the hand, wrist, or elbow. Although upper arm movement may be slow and limited to one joint at a time, myoelectric control of movement may be considered the most physiologically natural.
 
Myoelectric hand attachments are similar in form to those offered with the body-powered prosthesis, but are battery powered.
 
A hybrid system, a combination of body-powered and myoelectric components, may be used for high-level amputations (at or above the elbow). Hybrid systems allow control of two joints at once (i.e., one body-powered and one myoelectric) and are generally lighter and less expensive than a prosthesis composed entirely of myoelectric components.
 
Technology in this area is rapidly changing, driven by advances in biomedical engineering and by the U.S. Department of Defense Advanced Research Projects Agency (DARPA), which is funding a public and private collaborative effort on prosthetic research and development. Areas of development include the use of skin-like silicone elastomer gloves, “artificial muscles,” and sensory feedback. Smaller motors, microcontrollers, implantable myoelectric sensors, and re-innervation of remaining muscle fibers are being developed to allow fine movement control. Lighter batteries and newer materials are being incorporated into myoelectric prostheses to improve comfort.
 
Regulatory Status
Manufacturers must register prostheses with the restorative devices branch of the U.S. Food and Drug Administration (FDA) and keep a record of any complaints but do not have to undergo a full FDA review.
 
Available myoelectric devices include ProDigits™ and i-limb™ (Touch Bionics), the Otto Bock myoelectric prosthesis and the Michelangelo® Hand (Otto Bock), the LTI Boston Digital Arm™ System (Liberating Technologies), the Utah Arm Systems (Motion Control), and bebionic (steeper).
 
In 2014, the DEKA Arm System, now called the LUKE™ arm (DEKA Integrated Solutions, now DEKA Research & Development) was cleared for marketing by FDA through the de novo 513(f)(2) classification process for some novel low- to moderate-risk medical devices that are first-of-a-kind.
 
Lower limb prostheses are addressed in policy No. 2006011 (microprocessor-controlled prosthesis for the lower limb).

Policy/
Coverage:
Effective August 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Myoelectric upper-limb prosthetic components meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when the following conditions are met:
 
    • The patient has an amputation or missing limb at the wrist or above (eg, forearm, elbow); and
    • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; and
    • The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; and
    • The patient has demonstrated sufficient neurologic and cognitive function to operate the prosthesis effectively; and
    • The patient is free of comorbidities that could interfere with function of the prosthesis (eg, neuromuscular disease); and
    • Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (eg, gripping, releasing, holding, coordinating movement of the prosthesis) when performing activities of daily living. This evaluation should consider the patient’s needs for control, durability (maintenance), function (speed, work capability), and usability.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Upper-limb prosthetic components with both sensor and myoelectric control do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, upper-limb prosthetic components with both sensor and myoelectric control are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, a prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Myoelectric controlled upper-limb orthoses do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, myoelectric controlled upper-limb orthoses are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Myoelectric upper-limb prosthetic components under all other conditions do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, myoelectric upper-limb prosthetic components under all other conditions are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective August 2017 - July 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Myoelectric upper extremity and hand prosthesis meet member benefit certificate primary coverage criteria and are covered when ALL of the following criteria are met:
    • Traumatic amputation or congenital absence; AND
    • Standard body powered devices cannot be used or are insufficient to meet the functional needs when performing activities of daily living; AND
    • Evaluation indicates the requested device will meet the functional needs of the individual when coordinating movements and performance of ADLs. The evaluation should also discuss the individual need for control, function, usability and durability; AND
    • Evaluation indicates sufficient cognitive and neurologic ability to utilize myoelectric device and there is an absence of co-morbidities that could interfere with use of prosthesis (i.e., neuromuscular disease, spinal cord injury).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Duplication or upgrades of a functional prosthetic does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, duplication or upgrades of a functional prosthetic is considered not medically necessary. Services considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Myoelectric upper extremity and hand prosthesis for any indication not specified as covered above does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, myoelectric upper extremity and hand prosthesis for any indication not specified as covered above is considered not medically necessary. Services considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
A partial hand prosthesis does not meet member benefit certificate primary coverage criteria and is not covered. For members with contracts without primary coverage criteria, a partial hand prosthesis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 Prosthetics or modifications used for tasks other than activities of daily living do not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, prosthetics or modifications used for tasks other than activities of daily living are considered not medically necessary. Services considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective June 2013 - July 2017
 
Myoelectric upper arm prosthetic components meet member benefit primary coverage criteria  when the following conditions are met:
 
    • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; and
    • Evaluation indicates that a myoelectric prosthesis meets the functional needs of the individual in performing activities of daily living and that the patient has demonstrated sufficient physiological and cognitive function to allow effective operation of a myoelectric prosthetic device
 
A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, a prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to June 2013
Myoelectric upper arm prosthetic components meet member benefit primary coverage criteria  when the following conditions are met:
 
    • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; and
    • Evaluation indicates that a myoelectric prosthesis meets the functional needs of the individual in performing activities of daily living and that the patient has demonstrated sufficient physiological and cognitive function to allow effective operation of a myoelectric prosthetic device
 

Rationale:
Prospective comparative studies with objective and subjective measures would provide the most informative data on which to compare different prostheses, but little evidence was identified that directly addressed whether myoelectric prostheses improve function and health-related quality of life.
 
The available indirect evidence is based on two assumptions: 1) use of any prosthesis confers clinical benefit, and 2) self-selected use is an acceptable measure of the perceived benefit (combination of utility, comfort, and appearance) of a particular prosthesis for that individual. Most of the studies that were identified describe amputees’ self-selected use or rejection rates. The results are usually presented as hours worn at work, hours worn at home, and hours worn in social situations. Amputees’ self-reported reasons for use and abandonment are also frequently reported. It should be considered that upper limb amputee’s needs may depend on the particular situation. For example, increased functional capability may be needed with heavy work or domestic duties, while a more naturally appearing prosthesis with reduced functional capability may be acceptable for an office, school, or other social environment.
 
Comparative Studies
One prospective controlled study compared preferences for body-powered and myoelectric hands in children (Kruger, 1993).  Juvenile amputees (toddlers to teenagers, n=120) were fitted in a randomized order with one of the two types of prostheses; after a 3-month period, the terminal devices were switched, and the children selected one of the prostheses to use. After 2 years, some (n=11) of the original study sites agreed to reevaluate the children, and 78 (74% follow-up from the 11 sites) appeared for interview and examination. At the time of follow-up, 34 (44%) were wearing the myoelectric prosthesis, 26 (34%) were wearing a body-powered prosthesis (13 used hands and 13 used hooks), and 18 (22%) were not using a prosthesis. There was no difference in the children’s ratings of the myoelectric and body-powered devices (3.8 on a 5-point scale). Of the 60 children who wore a prosthesis, 19 were considered to be “passive” users, i.e., they did not use the prosthesis to pick up or hold objects (prehensile function). A multicenter within-subject randomized study, published in 1993, compared function with myoelectric and body-powered hands (identical size, shape, and color) in 67 children with congenital limb deficiency and 9 children with traumatic amputation (Edelstein, 1993).  Each type of hand was worn for 3 months before functional testing. Some specific tasks were performed slightly faster with the myoelectric hand; others were performed better with the body-powered hand. Overall, no clinically important differences were found in performance. Interpretation of these results is limited by changes in technology since this study was published.
 
Silcox and colleagues conducted a within-subject comparison of preference for body-powered or myoelectric prostheses in adults (Silcox, 1993).  Of 44 patients who had been fitted with a myoelectric prosthesis, 40 (91%) also owned a body-powered prosthesis and 9 (20%) owned a passive prosthesis. Twenty-two (50%) patients had rejected the myoelectric prosthesis, 13 (32%) had rejected the body-powered prosthesis, and 5 (55%) had rejected the passive prosthesis. Use of a body-powered prosthesis was unaffected by the type of work; good to excellent use was reported in 35% of patients with heavy work demands and 39% of patients with light work demands. In contrast, the proportion of patients using a myoelectric prosthesis was higher in the group with light work demands (44%) in comparison with those with heavy work demands (26%). There was also a trend toward higher use of the myoelectric prosthesis (n=16) in comparison with a body-powered prosthesis (n=10) in social situations. Appearance was cited more frequently (19 patients) as a reason for using a myoelectric prosthesis than any other factor. Weight (16 patients) and speed (10 patients) were more frequently cited than any other factor as reasons for non-use of the myoelectric prosthesis.
 
A cross-sectional study from 10 Shriners Hospitals assessed the benefit of a prosthesis (type not described) on function and health-related quality of life in 489 children aged 2–20 years of age with a congenital below the elbow deficiency (specific type of hand malformation) (James, 2006).  Outcomes consisted of parent- and child-reported quality of life and musculoskeletal health questionnaires and subjective and objective functional testing of children with and without a prosthesis. Age-stratified results were compared for 321children who wore a prosthesis and 168 who did not, along with normative values for each age group. The study found no clinically relevant benefit for prosthesis wearers compared with non-wearers, or for when the wearers were using their prosthesis. Non-wearers performed better than wearers on a number of tasks. For example, in the 13- to 20-year-old group, non-wearers scored higher than wearers for zipping a jacket, putting on gloves, peeling back the plastic cover of a snack pack, raking leaves, and throwing a basketball. Although prostheses have been assumed to improve function, no benefit was identified for young or adolescent children with this type of congenital hand malformation.
 
Non-Comparative Studies
A systematic review of 40 articles published over the previous 25 years assessed upper limb prosthesis acceptance and abandonment (Biddiss, 2007).   For pediatric patients the mean rejection rate was 38% for passive prostheses (1 study), 45% for body-powered prostheses (3 studies), and 32% for myoelectric prostheses (12 studies). For adults there was considerable variation between studies, with mean rejection rates of 39% for passive (6 studies), 26% for body-powered (8 studies), and 23% for myoelectric (10 studies) prostheses. The study authors found no evidence that the acceptability of passive prostheses had declined over the period from 1983 to 2004, “despite the advent of myoelectric devices with functional as well as cosmetic appeal.” Body-powered prostheses were also found to have remained a popular choice, with the type of hand-attachment being the major factor in acceptance. Body-powered hooks were considered acceptable by many users, but body-powered hands were frequently rejected (80%–87% rejection rates) due to slowness in movement, awkward use, maintenance issues, excessive weight, insufficient grip strength, and the energy needed to operate. Rejection rates of myoelectric prostheses tended to increase with longer follow-up. There was no evidence of a change in rejection rates over the 25 years of study, but the results are limited by sampling bias from isolated populations and the generally poor quality of the studies included.
 
Biddis and Chau published results from an online or mailed survey of 242 upper limb amputees from the United States, Canada, and Europe (Biddiss, 2007).  Of the survey respondents, 14% had never worn a prosthesis and 28% had rejected regular prosthetic use; 64% were either full-time or consistent part-time wearers. Factors in device use and abandonment were the level of limb absence, gender, and perceived need (e.g., working, vs. unemployed). Prosthesis rejectors were found to discontinue use due to a lack of functional need, discomfort (excessive weight and heat), and impediment to sensory feedback. Dissatisfaction with available prosthesis technology was a major factor in abandoning prosthesis use. No differences between users and non-users were found for experience with a particular type of prosthesis (passive, body-powered, or myoelectric) or terminal device (hand or hook).
 
In another online survey, the majority of the 43 responding adults used a myoelectric prosthetic arm and/or hand for 8 or more hours at work/school (about 86%) or for recreation (67%), while the majority of the 11 child respondents used their prosthesis for 4 hours or less at school (72%) or for recreation (88%) (Pylatiuk, 2007).  Satisfaction was greatest (more than 50% of adults and 100% of children) for the appearance of the myoelectric prosthesis and least (more than 75% of adults and 50% of children) for the grasping speed, which was considered too slow. Out of 33 respondents with a transradial amputation, 55% considered the weight “a little too heavy” and 24% considered the weight to be “much too high.” The types of activities that the majority of adults (between 50% and 80%) desired to perform with the myoelectric prosthesis were handicrafts, operation of electronic and domestic devices, using cutlery, personal hygiene, dressing and undressing, and to a lesser extent, writing. The majority (80%) of children indicated that they wanted to use their prosthesis for dressing and undressing, personal hygiene, using cutlery, and handicrafts.
 
The goals of upper limb prostheses relate to restoration of both appearance and function while maintaining sufficient comfort for continued use. The identified literature focuses primarily on patient acceptance and reasons for disuse; detailed data on function and functional status, and direct comparisons of body-powered and newer model myoelectric prostheses are limited/lacking. The limited evidence available suggests that in comparison with body-powered prostheses, myoelectric components may improve range of motion to some extent, have similar capability for light work, but may have reduced performance under heavy working conditions. The literature also indicates that the percentage of amputees who accept use of a myoelectric prosthesis is about the same as those who prefer to use a body-powered prosthesis, and that self-selected use depends at least in part on the individual’s activities of daily living. Appearance is most frequently cited as an advantage of myoelectric prostheses, and for patients who desire a restorative appearance, the myoelectric prosthesis can provide greater function than a passive prosthesis, with equivalent function to a body-powered prosthesis for light work. Nonuse of any prosthesis is associated with lack of functional need, discomfort (excessive weight and heat), and impediment to sensory feedback. Because of the differing advantages and disadvantages of the currently available prostheses, myoelectric components may be considered when passive or body-powered prostheses cannot be used or are insufficient to meet the functional needs of the patient in activities of daily living.
 
2012 Update
A search of the MEDLINE database was conducted through March 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
This policy is updated with a literature search through May 2013. The following is a summary of the key identified literature.
 
McFarland et al. conducted a cross-sectional survey of upper limb loss in veterans and service members from Vietnam (n=47) and Iraq (n=50) who were recruited through a national survey of veterans and service members who experienced combat-related major limb loss (McFarland, 2010). In the first year of limb loss, the Vietnam group received a mean of 1.2 devices (usually body-powered), while the Iraq group received a mean of 3.0 devices (typically 1 myoelectric/hybrid, 1 body-powered, and 1 cosmetic). At the time of the survey, upper-limb prosthetic devices were used by 70% of the Vietnam group and 76% of the Iraq group. Body-powered devices were favored by the Vietnam group (78%), while a combination of myoelectric/hybrid (46%) and body-powered (38%) devices were favored by the Iraq group. Replacement of myoelectric/hybrid devices was 3 years or longer in the Vietnam group while 89% of the Iraq group replaced myoelectric/hybrid devices in under 2 years. All types of upper limb prostheses were abandoned in 30% of the Vietnam group and 22% of the Iraq group; the most common reasons for rejection included short residual limbs, pain, poor comfort (e.g., weight of the device), and lack of functionality.
 
A 2009 study evaluated the acceptance of a myoelectric prosthesis in 41 children 2–5 years of age (Egermann, 2009). To be fitted with a myoelectric prosthesis, the children had to communicate well and follow instructions from strangers, have interest in an artificial limb, have bimanual handling (use of both limbs in handling objects), and have a supportive family setting. A 1- to 2-week interdisciplinary training program (in-patient or out-patient) was provided for the child and parents. At a mean 2 years’ follow-up (range 0.7–5.1 years), a questionnaire was distributed to evaluate acceptance and use during daily life (100% return rate). Successful use, defined as a mean daily wearing time of more than 2 hours, was achieved in 76% of the study group. The average daily use was 5.8 hours per day (range 0–14 hours). The level of amputation significantly influenced the daily wearing time, with above elbow amputees wearing the prosthesis for longer periods than children with below elbow amputations. Three of 5 children (60%) with amputations at or below the wrist refused use of any prosthetic device. There were trends (i.e., did not achieve statistical significance in this sample) for increased use in younger children, in those who had in-patient occupational training, and in those children who had a previous passive (vs. body-powered) prosthesis. During the follow-up period, maintenance averaged 1.9 times per year (range of 0–8 repairs); this was correlated with the daily wearing time. The authors discussed that a more important selection criteria than age was the activity and temperament of the child; for example, a myoelectric prosthesis would more likely be used in a calm child interested in quiet bimanual play, whereas a body-powered prosthesis would be more durable for outdoor sports, and in sand or water. Due to the poor durability of the myoelectric hand, this group provides a variety of prosthetic options to use depending on the situation. The impact of multiple prostheses types (e.g., providing both a myoelectric and body-powered prosthesis) on supply costs, including maintenance frequency, are unknown at this time.
 
An evaluation of a rating scale called the Assessment of Capacity for Myoelectric Control (ACMC) was described by Lindner and colleagues in 2009 (Lindner, 2009). For this evaluation of the ACMC, a rater identified 30 types of hand movements in a total of 96 patients (age range 2–57 years) who performed a self-chosen bimanual task, such as preparation of a meal, making the bed, doing crafts, or playing with different toys; each of the 30 types of movements was rated on a 4-point scale (not capable or not performed, sometimes capable, capable on request, and spontaneously capable). The types of hand movements were variations of four main functional categories (gripping, releasing, holding, and coordinating), and the evaluations took approximately 30 minutes. Statistical analysis indicated that the ACMC is a valid assessment for measuring differing ability among users of upper limb prostheses, although the assessment was limited by having the task difficulty determined by the patient (e.g., a person with low ability might have chosen a very easy and familiar task). Lindner et al. recommended that further research with standard tasks is needed and that additional tests of reliability are required to examine the consistency of the ACMC over time.
 
Although the availability of a myoelectric hand with individual control of digits has been widely reported in lay technology reports, video clips and basic science reports, no peer-reviewed publications were found to evaluate functional outcomes of individual digit control in amputees. The policy statement has been changed to include a statement handling prosthetics with individually powered digits, including but not limited to a partial hand prosthesis.
 
   
2014 Update
A literature search conducted through May 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through July 2018.  The key identified literature is summarized below.
 
MYOELECTRIC UPPER-LIMB PROSTHESIS
 
Acceptance Rates in Children
Sjoberg et al conducted a prospective long-term case-control study to determine whether fitting a myoelectric prosthesis before 2.5 years of age improved prosthesis acceptance rates compared with the current Scandinavian standard of fitting between 2.5 and 4 years old (Sjoberg, 2017). All children had a congenital amputation and had used a passive hand prosthesis from 6 months of age, and both groups were fitted with the same type of prosthetic hand and received structured training beginning at 3 years of age. They were followed every 6 months between 3 and 6 years of age and then as needed for service or training for a total of 17 years. By 12 years of age both groups achieved maximum performance on the Skills Index Ranking Scale, although 3 (33%) children in the case group and 4 (15%) in the control group were lost to follow-up at after 9 years of age due to prosthetic rejection. This difference was not statistically significant in this small study. Overall, study results did not favor earlier intervention with a myoelectric prosthesis.
 
SENSOR AND MYOELECTRIC UPPER-LIMB COMPONENTS
Investigators from 3 Veterans Administration medical centers and the Center for the Intrepid at Brooke Army Medical Center published a series of reports on home use of the LUKE prototype (DEKA Gen 2 and DEKA Gen 3) in 2017 and 2018. Participants were included in the in-laboratory training if they met criteria and had sufficient control options (e.g., myoelectric and/or active control over one or both feet) to operate the device. In-lab training included a virtual reality training component. At the completion of the in-lab training, the investigators determined, using a priori criteria, which participants were eligible to continue to the 12-week home trial. The criteria included the independent use of the prosthesis in the laboratory and community setting, fair, functional performance, and sound judgment when operating or troubleshooting minor technical issues. On ClinicalTrials.gov, the total enrollment target is listed as 100 patients with study completion by February 2018 (NCT01551420).
 
One of the publications (Resnick, 2017) reported on the acceptance of the LUKE prototype before and after a 12-week trial of home use.7 Of 42 participants enrolled at the time, 32 (76%) participants completed the in-laboratory training, 22 (52%) wanted to receive a LUKE Arm and proceeded to the home trial, 18 (43%) completed the home trial, and 14 (33%) expressed a desire to receive the prototype at the end of the home trial. Over 80% of those who completed the home trial preferred the prototype arm for hand and wrist function, but as many preferred the weight and look of their own prosthesis. One-third of those who completed the home training thought that the arm was not ready for commercialization. Participants who completed the trial were more likely to be prosthesis users at study onset (p=0.03), and less likely to have musculoskeletal problems (Resnik, 2018). Reasons for attrition during the in-laboratory training were reported in a separate publication by Resnik and Klinger (Resnik, 2017). Attrition was related to the prosthesis entirely or in part by 67% of the participants, leading to a recommendation to provide patients with an opportunity to train with the prosthesis before a final decision about the appropriateness of the device.
 
Functional outcomes of the Gen 2 and Gen 3 arms, as compared with participants’ prostheses, were reported by Resnick et al (Resnik 2018). At the time of the report, 23 regular prosthesis users had completed the in-lab training, and 15 had gone on to complete the home use portion of the study. Outcomes were both performance-based and self-reported measures. At the end of the lab training, dexterity was similar, but performance was slower with the LUKE prototype than with their conventional prosthesis. At the end of the home study, activity speed was similar to the conventional prostheses, and one of the performance measures (Activities Measure for Upper-Limb Amputees) was improved. Participants also reported that they were able to perform more activities, had less perceived disability, and less difficulty in activities, but there were no differences between the 2 prostheses on many of the outcome measures including dexterity, prosthetic skill, spontaneity, pain, community integration, or quality of life. Post hoc power analysis suggested that evaluation of some outcomes might not have been sufficiently powered to detect a difference.
 
In a separate publication, Resnick reported that participants continued to use their prosthesis (average, 2.7 h/d) in addition to the LUKE prototype, concluding that availability of both prostheses would have the greatest utility (Resnik, 2017). This conclusion is similar to those from earlier prosthesis surveys, which found that the selection of a specific prosthesis type (myoelectric, powered, or passive) could differ depending on the specific activity during the day. In the DEKA Gen 2 and Gen 3 study reported here, 29% of participants had a body-powered device, and 71% had a conventional myoelectric prosthesis.
 
Section Summary: Sensor and Myoelectric Upper-Limb Components
The LUKE Arm was cleared for marketing in 2014 and is now commercially available. The prototypes for the LUKE Arm, the DEKA Gen 2 and Gen 3, were evaluated by the U.S. military and Veteran’s Administration in a 12-week home study, with study results reported in a series of publications. Acceptance of the advanced prosthesis in this trial was mixed, with one-third of enrolled participants desiring to receive the prototype at the end of the trial. Demonstration of improvement in function has also been mixed. After several months of home use, activity speed was shown to be similar to the conventional prosthesis. There was an improvement in the performance of some, but not all, activities. Participants continued to use their prosthesis for part of the day, and some commented that the prosthesis was not ready for commercialization. There were no differences between the LUKE Arm prototype and the participants’ prostheses for many outcome measures. Study of the current generation of the LUKE Arm is needed to determine whether the newer models of this advanced prosthesis lead to consistent improvements in function and quality of life.
 
MYOELECTRIC HAND WITH INDIVIDUAL DIGIT CONTROL
Although the availability of a myoelectric hand with individual control of digits has been widely reported in lay technology reports, video clips, and basic science reports, no peer-reviewed publications were found to evaluate functional outcomes of individual digit control in amputees.
 
MYOELECTRIC ORTHOTIC
Peters evaluated the immediate effect (no training) of a myoelectric elbow-wrist-hand orthosis on paretic upper-extremity impairment (Peters, 2017). Participants (n=18) were stable and moderately impaired with a single stroke 12 months or later before study enrollment. They were tested using a battery of measures without, and then with the device; the order of testing was not counterbalanced. The primary measure was the upper-extremity section of the Fugl-Meyer Assessment, a validated scale that determines active movement. Upper-extremity movement on the Fugl-Meyer Assessment was significantly improved while wearing the orthotic (a clinically significant increase of 8.71 points, p<0.001). The most commonly observed gains were in elbow extension, finger extension, grasping a tennis ball, and grasping a pencil. The Box and Block test (moving blocks from one side of a box to another) also improved (p<0.001). Clinically significant improvements were observed for raising a spoon and cup, and there were significant decreases in the time taken to grasp a cup and gross manual dexterity. Performance on these tests changed from unable to able to complete. The functional outcome measures (raising a spoon and cup, turning on a light switch, and picking up a laundry basket with 2 hands) were developed by the investigators to assess these moderately impaired participants. The authors noted that performance on these tasks was inconsistent, and proposed a future study that would include training with the myoelectric orthosis before testing.
 
Section Summary: Myoelectric Orthotic
The largest study identified tested participants with and without the orthosis. This study evaluated the function with and without the orthotic in stable post stroke participants who had no prior experience with the device. Outcomes were inconsistent. Studies are needed that show consistent improvements in relevant outcome measures. Results should also be replicated in a larger number of patients.

CPT/HCPCS:
L6026Transcarpal/metacarpal or partial hand disarticulation prosthesis, external power, self-suspended, inner socket with removable forearm section, electrodes and cables, two batteries, charger, myoelectric control of terminal device, excludes terminal device(s)
L6715Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement
L6880Electric hand, switch or myolelectric controlled, independently articulating digits, any grasp pattern or combination of grasp patterns, includes motor(s)
L6881Automatic grasp feature, addition to upper limb electric prosthetic terminal device
L6882Microprocessor control feature, addition to upper limb prosthetic terminal device
L6925Wrist disarticulation, external power, self-suspended inner socket, removable forearm shell, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L6935Below elbow, external power, self-suspended inner socket, removable forearm shell, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L6945Elbow disarticulation, external power, molded inner socket, removable humeral shell, outside locking hinges, forearm, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L6955Above elbow, external power, molded inner socket, removable humeral shell, internal locking elbow, forearm, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L6965Shoulder disarticulation, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L6975Interscapular-thoracic, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, Otto Bock or equal electrodes, cables, 2 batteries and one charger, myoelectronic control of terminal device
L7007Electric hand, switch or myoelectric controlled, adult
L7008Electric hand, switch or myoelectric, controlled, pediatric
L7009Electric hook, switch or myoelectric controlled, adult
L7045Electric hook, switch or myoelectric controlled, pediatric
L8701Powered upper extremity range of motion assist device, elbow, wrist, hand with single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated
L8702Powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated

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McFarland LV, Hubbard Winkler SL, Heinemann AW et al.(2010) Unilateral upper-limb loss: satisfaction and prosthetic-device use in veterans and servicemembers from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev 2010; 47(4):299-316.

Peters HT, Page SJ, Persch A.(2017) Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke. Ann Rehabil Med. Sep 2017;98(9):1821-1827. PMID 28130084

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Resnik L, Acluche F, Borgia M.(2017) The DEKA hand: A multifunction prosthetic terminal device-patterns of grip usage at home. Prosthet Orthot Int. Sep 1 2017:309364617728117. PMID 28914583

Resnik L, Acluche F, Lieberman Klinger S, et al.(2017) Does the DEKA Arm substitute for or supplement conventional prostheses. Prosthet Orthot Int. Sep 1 2017:309364617729924. PMID 28905665

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Resnik LJ, Borgia ML, Acluche F.(2017) Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use. PLoS One. Jun 2017;12(6):e0178640. PMID 28575025

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