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Clinical Practice Guidelines for the Rehabilitation of Lower Limb Amputation

An Update from the Department of Veterans Affairs and Department of Defense

Webster, Joseph B. MD; Crunkhorn, Andrea DPT; Sall, James PhD; Highsmith, M. Jason PhD; Pruziner, Alison DPT; Randolph, Billie J. PhD

American Journal of Physical Medicine & Rehabilitation: September 2019 - Volume 98 - Issue 9 - p 820–829
doi: 10.1097/PHM.0000000000001213
Analysis & Perspective
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Between 2015 and 2017, the US Department of Veterans Affairs and the US Department of Defense developed a clinical practice guideline for rehabilitation of lower limb amputation to address key clinical questions. A multidisciplinary workgroup of US Department of Veterans Affairs and US Department of Defense amputation care subject matter experts was formed, and an extensive literature search was performed which identified 3685 citations published from January 2007 to July 2016. Articles were excluded based on established review criteria resulting in 74 studies being considered as evidence addressing one or more of the identified key issues. The identified literature was evaluated and graded using the National Academies of Science GRADE criteria. Recommendations were formulated after extensive review. Eighteen recommendations were confirmed with four having strong evidence and workgroup confidence in the recommendation. Key recommendations address patient and caregiver education, consideration for the use of rigid and semirigid dressings, consideration for the use of microprocessor knees, and managed lifetime care that includes annual transdisciplinary assessments. In conclusion, this clinical practice guideline used the best available evidence from the past 10 yrs to provide key management recommendations to enhance the quality and consistency of rehabilitation care for persons with lower limb amputation.

From the US Department of Veterans Affairs Rehabilitation and Prosthetic Services, Washington, DC (JBW, MJH); Virginia Commonwealth University, Richmond, Virginia (JBW); US Departments of Defense and Veterans Affairs Extremity Trauma & Amputation Center of Excellence, San Antonio, Texas (AC, MJH, AP, BJR); Department of Rehabilitation Medicine, Uniformed Services University, Bethesda, Maryland (AC, AP); Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, Maryland (AC, AP); US Department of Veterans Affairs Office of Quality, Safety and Value (JS); Texas A&M University – Corpus Christi, College of Nursing and Health Sciences, Corpus Christi, Texas (JS); and University of South Florida, School of Physical Therapy & Rehabilitation Sciences, Tampa, Florida (MJH).

All correspondence should be addressed to: Joseph B. Webster, MD, 1201 Broad Rock Blvd, Richmond, VA 23112.

This study was supported by the Departments of Defense and Veterans Affairs. Material was presented at the 2018 AAPM&R Annual Assembly on October 26, 2018.

Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article.

Online date: May 13, 2019

Studies have estimated that there are more than two million persons currently living in the United States with upper or lower limb amputations and that approximately 500 new amputations are performed each day.1 As a result of factors, such as the increasing rate of diabetes, growth of this population is expected in the future with predictions that the population of individuals with amputations will double by 2050.2 The Departments of Veterans Affairs (VA) and Defense (DOD) also have experienced an increase in the number of veterans and service members with amputation. In the VA, the total number of veterans with amputations being seen at VA facilities increased from 36,222 in 2001 to more than 90,000 in 2017.3 In 2017, there were more than 10,000 new amputations performed in the VA with most amputations resulting from disease processes, such as vascular disease and diabetes. Between January 1, 2001, and December 31, 2017, 1718 U.S. Service Members sustained at least one conflict-related amputation (excluding digit amputations) with the majority resulting from improvised explosive device blast exposures. Among these service members who experienced amputation, 84% involved the lower limb with 8% involving both lower limbs. It has been noted by the VA Office of Inspector General that 99% of service members with combat-related amputations transition at least part of their care to the VA within 5 yrs of military separation.4

The VA and DOD previously published a lower limb amputation (LLA) rehabilitation clinical practice guideline (CPG) in 2007. The decision to update this guidance was based on the recognition that a significant body of research had been published in the subsequent decade and that similar guidance documents had not been published outside of the federal sector. Thus, in an effort to enhance the quality and consistency of rehabilitation care for this population, the VA and DOD completed a 2-yr project to develop a new CPG for LLA rehabilitation. The primary objective of the CPG was to provide health care providers with an evidence-based framework to evaluate and manage persons with LLA in the context of their individual needs and preferences. This article is a summary of the key recommendations in the CPG and is designed to enhance awareness and adoption of these recommendations outside of the federal sector. The entire CPG can be obtained at https://www.healthquality.va.gov/guidelines/Rehab/amp/.

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METHODOLOGY

The joint VA and US Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) has established standards for trustworthy guideline development as determined by the Institute of Medicine. The EBPWG provides oversight for the development and publication of joint VA and DoD practice guidelines that are of clinical importance to the populations served by these agencies.5 For the guideline referenced in the article, the EBPWG selected a panel of 5 co-chairs from the VA and the DoD to lead a multidisciplinary panel of 15 additional subject matter experts representing physiatrists, physical therapists, prosthetists, occupational therapists, psychologists, surgeons, and nurses. All members of the multidisciplinary panel were involved in each stage of the development process and each panel member was required to submit a disclosure statement for potential conflicts of interest. Any potential conflicts of interest were reviewed by the EBPWG to ensure a development process free from bias.

The Lewin Group and ECRI Institute were contracted by the VA and DoD to facilitate the CPG development and conduct the literature review respectively. The guideline panel developed ten key questions using the PICOTS (population, intervention, comparator, outcomes, timing of outcomes measurement, and setting) format to establish the scope of the literature review. Using standard search strategies, which are detailed in the full guideline, ECRI Institute conducted systematic searches of the peer-reviewed literature to identify relevant randomized trials, systematic reviews, and meta-analyses of fair or better quality published between January 2007 and July 2016. The search initially identified 3685 citations and of those, and 2058 were excluded upon title review. This left 1627 abstracts for review. A total of 397 full-length articles were reviewed, and after a first pass review, 74 studies were identified that addressed one or more of the key questions and met the criteria for use as evidence for the review (Fig. 1). Table 1 displays how the identified literature related to each of the 10 key questions.

FIGURE 1

FIGURE 1

TABLE 1

TABLE 1

The guideline panel used the National Academies of Science GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology to assess and categorize the quality of the research evidence. After extensive review of the available literature and through workgroup consensus, the strength of each recommendation was determined based on the quality of the research evidence as well as the additional domains of the GRADE criteria (Table 2). The GRADE methodology does not allow for recommendations to be made based on expert opinion alone.6–8 The guideline panel focused on the development of new recommendations using the key question evidence review but also considered, without a complete review of the relevant evidence, the current applicability of recommendations included in a previously published joint VA and DoD amputation care CPG. The previously published CPG contained a total of 215 recommendations, and after question review and comparison with the current literature review, a total of 7 prior recommendations were brought forward to the new guideline in revised format.

TABLE 2

TABLE 2

As part of the development process, a focus group of patients with LLA receiving amputation rehabilitation services in the VA and/or DoD was convened. The number of participants in the focus group was kept under ten to meet the requirements of the Paperwork Reduction Act while acknowledging that this convenience sample may not be representative of all VA and DoD patients with LLA. The focus group explored patient perspectives on a wide spectrum of topics related to LLA rehabilitation in the VA and DoD healthcare systems. Important concepts that emerged from the focus group were shared with the guideline panel and informed guideline recommendation development.

The guideline development process also included a review of the draft guideline by expert reviewers both inside and outside the federal sector. Reviewer comments were considered by the guideline panel, and where appropriate, these edits were incorporated into the final guideline based on panel consensus and consistency with the evidence review. Through a series of meeting presentations, the VA/DoD EBPWG provided final review and approval of the CPG for release in September 2017.

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RECOMMENDATIONS

All Phases of Amputation Rehabilitation (Recommendations 1–6)

The guideline workgroup concluded 18 key recommendations (Table 3) of which six were determined to be applicable across all phases of LLA rehabilitation as defined in the guideline. Using the GRADE criteria, five of the six recommendations in this grouping were determined to have weak evidence support and one of the six was determined to have strong evidence support. Figure 2 provides overall treatment algorithm highlighting the key considerations and decision points during each phase of rehabilitation.

TABLE 3

TABLE 3

FIGURE 2

FIGURE 2

The guideline emphasizes the importance of patient education across the continuum of care (Recommendation 1). Although the content and delivery method of the education will vary depending on the phase of rehabilitation and the care setting, successful education requires a transdisciplinary team that creates a holistic approach, using concepts and methods from the multiple disciplines. Once the patient's individual educational needs are identified, then the most appropriate verbal, written, or hands-on learning method can be initiated. The CPG suggests that clinicians should provide clear advice and information on topics, such as surgical interventions, rehabilitation programs, prosthetic options, and potential outcomes for patients to make informed care decisions and develop realistic goals during each phase of their rehabilitation.9,10

Psychosocial functioning refers to the ability of the individual with limb loss to cope with the psychological and social factors that influence his/her personal relationships, work, school, and social performance. Adjustment to loss of a limb can be challenging and patients may experience depression, anxiety, and posttraumatic stress symptoms. The CPG emphasizes the performance of routine, periodic assessments during each phase of care that include inquiries into mental health concerns, social functioning, spiritual beliefs, and coping mechanisms (Recommendation 2). Many of these issues can be addressed by the transdisciplinary rehabilitation team with referral to a mental health specialist as indicated. Relevant VA/DoD CPGs are available for patients at risk for suicide, major depressive disorder, posttraumatic stress and acute stress reaction, or substance use disorder.11–14

Two recommendations in this section relate to pain management. The first emphasizes that although pain is a subjective and individual experience, when possible, it should be assessed with standardized and validated tools. These assessments should include characteristics, such as location, intensity, character, duration, timing, and aggravating factors or triggers.15 Equally important to measuring the intensity of pain is to consider the effects of pain on a patient's function. The pain types commonly encountered after LLA include, but are not limited to, residual limb pain including neuropathic pain, phantom limb pain and sensation, other visceral, or musculoskeletal pains, as well as pre-existing pain syndromes or comorbidities. Successful pain management postamputation promotes enhanced recovery, higher patient satisfaction, and lower cost of care.

The guideline also recommends offering a multimodal, transdisciplinary individualized approach to pain management throughout all rehabilitation phases (Recommendation 4). There are multiple pharmacological and nonpharmacological options for treating pain and the pain management approach should include transitioning to a nonnarcotic pharmacological regimen combined with physical, psychological, and mechanical modalities.16 Variation in patient preference and response to treatments requires consideration for frequent adjustments to interventions. In addition to the standard long-term harms from chronic opioid therapy, sedation and balance issues from opioids may impede the rehabilitation progress in patients with LLA.

The guideline workgroup found strong evidence to support a recommendation for providers to consider the patient's birth sex and self-identified sex identity in development of treatment plans (Recommendation 5). Although most individuals with amputation in the United States are males, it is estimated that up to 35% of this population are females.2 There are significant differences between male and female birth sex patients in areas, such as successful prosthesis fitting, time in rehabilitation, use of coping self-statements, and pain catastrophizing.17–19 The evidence reflects that women with peripheral arterial disease are at greater risk for compromise in daily functioning, have poorer quality of life, and more often present with critical limb ischemia and higher levels of arterial lesions, resulting in more proximal level amputation.20

The early involvement of family members and contact with other patients with amputations is important for the patient's psychological adjustment (Recommendation 6).21 This support should be maintained throughout the rehabilitation process. The Commission on the Accreditation of Rehabilitation Facilities (CARF) Amputation Specialty Program requirements are consistent with research literature suggesting that peer visits work best when the age, sex, and amputation level are considered and matched.22,23 Involvement in some type of support program can be beneficial for both the patient and the family/caregiver.22 Although initial introductory visits between a new patient and the peer visitor are best done in person, follow-up visits or contact for patients who are not within a reasonable distance from a peer center can use other forms of communication to broaden the patient's access to a peer visitor or support group.

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Perioperative Phase (Recommendations 7–14)

The perioperative recommendations (Recommendations 7–14) center around the care provided immediately before and after amputation surgery. Based on the available evidence, the guideline suggests that before surgery the patient, caregiver and rehabilitation team engage in shared decision-making about residual limb length, amputation level, and rehabilitation goals (Recommendation 7). Although long-term functional outcomes have favored more distal amputations,8,24,25 potential advantages should be weighed against negative surgical, componentry, and risk considerations. With insufficient evidence to recommend one surgical amputation procedure over another (Recommendation 8), preoperative shared decision- making and a transdisciplinary team approach will help the clinical care team meet the goals of a well-shaped and well-healed postsurgical limb allowing for the initiation of prosthesis use.

The evidence suggests the use of a rigid or semirigid postsurgical dressing to promote healing and earlier prosthesis use after transtibial amputation (Recommendation 9). Research shows that these removable dressings may reduce acute postamputation edema, healing and hospitalization time, wound infection rate, and time to prosthetic fitting when compared with soft elastic dressings.26–28 Rigid postoperative dressings are preferred in situations where limb protection is a priority. Limb protection, infection risk and need to inspect the incision site and skin, and other individual patient factors must be considered in the selection of dressing type.

Cognitive function has the potential to influence many aspects of amputation rehabilitation including compliance, prosthetic fitting success, independence, falls, and mortality rates. Performing cognitive screening before establishing rehabilitation goals allows the rehabilitation team to determine the most appropriate prosthetic technology (Recommendation 10). Different executive functions are predictive of prosthesis use, mobility, and locomotion, and dementia is predictive of increased mortality.29 The suggested initial screening within the guideline may indicate the need for more extensive or continued cognitive testing.

The evidence also suggests that patients in the perioperative phase of rehabilitation receive appropriate durable medical equipment and assistive technology (Recommendation 11). There is some research support for the use of residual limb positioning devices to prevent contractures and control edema in the residual limb.30–32 The strength of this recommendation is enhanced by the fact that the potential benefits of prescribing durable medical equipment and assistive technology early in the rehabilitation process likely outweigh potential harm. The guideline (Recommendation 12) also suggests that postsurgical treatment occur in an acute inpatient rehabilitation facility. Inpatient rehabilitation facility patients have been found to have improved quality of life, better ambulation and confidence, overall mobility, and increased prosthesis use with less associated pain. If safety is the sole concern, evidence supports rehabilitation in either an inpatient rehabilitation facility or a skilled nursing facility.33–35

Initiating mobility training as soon as possible postamputation may promote functional independence, strength, cardiovascular fitness, and bone health (Recommendation 13).31,36 This may include an early weight-bearing prosthesis although evidence on the most appropriate type of device to use at this stage has not been established based on the performed literature review. Use of a device may allow earlier gait re-education, accelerated residual limb healing, reduced complications, facilitation of prosthesis fitting, and a psychosocial benefit. Risk factors must be considered in determining the timing for mobility training.37

With strong evidence support, the guideline recommends maximizing function through rehabilitation interventions (Recommendation 14). This includes open and closed kinetic chain exercises and progressive resistance to improve gait, mobility, strength, cardiovascular fitness, and activities of daily living. The rehabilitation program should be individualized for intensity, part- to whole-resisted gait training, and functional gait training to improve self-selected walking speed.38–40 The patient focus group highlighted the importance of real-world training with more robust rehabilitation addressing complex situations, such as walking through an airport, that allow true community reintegration. The focus group also emphasized training in the performance of functional activities of daily living and self-care, with and without the prosthesis, to maximize confidence and independence. Providers should discuss all aspects of functional activities of daily living, including activities such as intimacy with a significant other, and use well-rounded training interventions to maximize patient comfort, confidence, and functionality.

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Preprosthetic Phase (Recommendation 15)

The guideline suggests offering microprocessor knee (MPK) units over non-MPK units for ambulation to reduce fall risk and maximize patient satisfaction (Recommendation 15). Falling is a major issue in patients with transfemoral amputations. The CPG recognizes that MPKs have been shown to reduce fall risk and maximize patient satisfaction.41,42 The prescription of MPKs over non-MPKs may also improve an individual's ability to walk faster on level ground, uneven surfaces and downhill.41 For individuals with complex medical conditions affecting balance as well as the geriatric population, MPKs may decrease stumbles and falls.41

There is insufficient evidence to support using one type of MPK over another. The provider and patient should consider the many characteristics of each type of knee, especially the potential impact on the patient's functional level. Some knees may be best suited for limited community ambulation, whereas others are more appropriate for higher levels of activity.27,43,44 Considerations also include the mechanism and ease of charging the MPK and the knee's default mode (locked knee or free swing) when the power source is depleted. For the active user additional options include activity modes and waterproof/water resistance features.

There are a large number and wide range of options with prosthetic components, such as suspension type, interface materials, and prosthetic feet. These options often have markedly different characteristics, advantages, and disadvantages. Based on the research findings, the panel workgroup concluded that there are inconclusive outcome differences in socket design, prosthetic foot categories, and advantages/disadvantages of various suspension and interface types. Each component of a prosthetic prescription should be carefully selected based on the user's capabilities and anticipated compliance as well as the residual limb's integrity and shape. Patient-desired outcomes, goals, and the compatibility of the entire prosthetic system should also be considered when prescribing prosthetic components.

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Prosthetic Training Phase (Recommendations 16–18)

The CPG recommends use of valid, reliable, and responsive functional outcome measures, including the Comprehensive High-level Activity Mobility Predictor, Amputee Mobility Predictor, 10-meter walk test, and 6-min walk test (Recommendation 16). Using validated objective outcome measures throughout rehabilitation yields direct feedback to providers and patients regarding intervention efficacy and progress toward functional goals. When choosing from the numerous outcome measures available, it is important to first select a measure that evaluates the construct of interest.45,46 Additional high priority factors are the validity, reliability, and responsiveness of the measure. Other issues to consider include the administrative burden to the patient and provider, the level of measurement, availability of reference or normative values, and cutoff scores.

Outcome measures may be population specific47,48 or may have more general utility. The Amputee Mobility Predictor is a physical performance measure of functional mobility that takes approximately 15 mins to administer. It provides ordinal scale data and has evidence of validity, reliability, and responsiveness.49,50 Reference values are available to understand a patient's score relative to others of comparable etiology and functional level. If a clinician needs a more direct assessment of walking ability, other outcome measures may be more appropriate, including the 10-meter walk test, the 2- or 6-min walk test, or others.49,50 The latter tests are not population specific and have some reference data available from patients with amputations and other diagnostic groups.49–53Table 4 provides supplemental information regarding additional measures of physical functional performance with evidence of reliability and validity in the LLA population.

TABLE 4

TABLE 4

The guideline suggests the use of a combination of measures, both physical functional performance and patient reported, with acceptable psychometric properties to assess functional outcomes (Recommendation 17). Rehabilitative care requires assessment of multiple domains including walking ability, balance, adjustment to prosthetic device use, quality of life, and others.27,44 In addition to selecting outcome measures that are valid, reliable, and responsive, comparably robust measures from the patient's perspective are important to include. Some examples are the Locomotor Capabilities Index54 and the Prosthesis Evaluation Questionnaire-Mobility Subscale,55 both of which assess the patient's perception of their mobility capabilities. It may also be important to include an assessment of the patient's perceptions regarding their confidence with balance, in which case the Activities-specific Balance Confidence Scale was determined be useful.56

In addition to the measures previously described, other domains may require assessment, such as the location, severity, and type of pain (e.g., low back, joint, phantom limb). Other phenomena that may require assessment include less objective, patient-reported events, such as the number of stumbles, semicontrolled falls, or uncontrolled falls. This assessment may be included as part of a specific instrument or can be asked separately.43,44,57 The CPG suggests that multiple outcome measures may be necessary to thoroughly assess the patient and track progress.

The guideline recognizes factors that are associated with poorer outcomes, such as smoking, medical comorbidities, psychosocial functioning, and pain (Recommendation 18). Evaluations and interventions that address a patient's comorbidities can both improve overall health and functional outcomes postamputation.58,59 Comorbidities, such as chronic obstructive pulmonary disease,60 congestive heart failure, myocardial infarction within the previous 6 mos, renal disease on dialysis,61 a positive “do not resuscitate” status, and a generally low functional status are associated with an increased mortality rate after amputation surgery.58 There is also an association between the presence of comorbidities and functional outcomes after amputation.59 Vascular disease and smoking as well as overall health status can cause skin issues, impede postoperative wound healing, and lead to recurrence of wounds after surgery.60 This can delay prosthetic fitting, the patient's ability to function with the device, and the patient's gait and pain levels resulting in decreased functional status and patient satisfaction. Chronic low back pain, obesity, and fluctuations in weight are issues that are other issues often experienced after LLA and should be monitored.62–64

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Additional Considerations

This CPG represents the most recent publication in a series of 3 guidelines related to the rehabilitation care of persons with amputations. Although there has been methodology evolution over time, all of these CPGs have used a structured development process to assure high-quality and clinically relevant products. One of the limitations of the CPG development process is that the literature review was restricted to only 10 key questions and 10-yr period. The development of this type of CPG is also very time-consuming and labor-intensive. This large investment in resources may be hard to replicate either within or outside of the federal sector in the future.

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CONCLUSIONS

The VA/DoD Clinical Practice Guideline for Rehabilitation of Individuals with Lower Limb Amputation is based on the best available evidence from the past 10 yrs and provides 18 recommendations addressing key clinical care questions related to LLA rehabilitation. The guideline provides a framework for managing persons with LLA in the context of their individual needs and preferences. Adoption and implementation of these recommendations have the potential to enhance the quality and consistency of rehabilitation care for this population.

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REFERENCES

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62. VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus Type 2 in Primary Care. Available at: https://www.healthquality.va.gov/guidelines/CD/diabetes/ Accessed December 9, 2018
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Keywords:

Amputation; Rehabilitation; Clinical Practice Guideline; Transdisciplinary; Limb Loss

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