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Section 2: Upper Limb
Tab le 1
Examples of Research Questions and the Recommended Applicable Measures (continued)
Field of Application Research
Question To Be Addressed ICF-Related
Component
How can we assess function for an individual with
upper limb loss/deciency not using a prosthesis?
c
AHA
b
COPM
b
GAS
How do we assess quality of life for an individual with
upper limb loss/deciency?
b
COPM
Disabkids
PedsQL
WHOQOL
A = Adult, ACMC = Assessment of Capacity of Myoelectric Control, AHA = Assisting Hand Assessment, COPM = Canadian Occupational Perfor­mance Measure, GAS = Goal Attainment Scale, ICF = International Classication of Functioning, Disability and Health, P = pediatric, PEDsQL = Pediatric Quality of Life Inventory, PODCI = Pediatric Outcomes Data Collection Instrument, PUFI = Prosthetic Upper Extremity Functional Index, QoL = quality of life, WHOQL = World Health Organization Quality of Life.
a
From Evidenced-based Review report and Upper Limb Prosthetic Outcome Measures Group
b
From Upper Limb Prosthetic Outcome Measures Group
c
From Evidenced-based Review report
Reproduced with permission from Miller LA, Swanson S: Summary of recommendations of the Academy’s State of the Science Conference. J Prosthet Orthot 2009;21[suppl4]:83-89.
b
b
b
Function and activity P
Activity and
participation
Activity and
participation
Activity and
participation
N/A (related to QoL) P P
N/A (related to QoL) P
N/A (related to QoL) A
Development Clinical Patient
Care
P, A P, A
P, A P, A
P, A P, A
approach is required to care for a patient with an upper limb prosthesis, and an occupational therapist can be included in the evaluation of the care plan. Many outcome measures require specialized training and/or the use of equipment that often is available to an occupation­al therapist. Several outcome measures are particularly relevant to the work of a prosthetist.
Assessment of Capacity for Myoelectric Control
The Assessment of Capacity for Myoelec­tric Control is based on observational analysis of an adult or pediatric patient with an upper limb prosthesis during functional bimanual activities.
10,18
The
measure was designed to evaluate the
Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
422
use of a myoelectric prosthetic hand but has been applied to other types of pros­theses and other levels of amputation. A 4-point scale is used to evaluate 22 aspects of prosthesis use (for example, the ability to hold an object over the course of a task, with or without sup­port; coordination with both hands; and the ability to adjust grip force, with or without visual feedback). Any bimanual task can be evaluated, if it allows all 22 aspects of use to be observed. The use of standardized activities in this measure was recently validated.19 User scores are entered into an online Rasch analysis to generate an overall rating of myoelectric control. In addition, prosthetists, thera­pists, and engineers are able to use the Assessment of Capacity for Myoelectric
Control; however, raters are required to complete a training course to obtain certification. This measure has been identified as appropriate in both patient care and research settings, although the amount of time required to use the tool may be challenging for a newly certified rater in the patient-care setting.
University of New Brunswick Test of Prosthetic Function
The University of New Brunswick Test of Prosthetic Function was specifically developed to evaluate prosthesis use in children with a unilateral upper limb amputation.20 This observational func­tion test was developed by an occu­pational therapist and an engineer to measure the method and spontaneity of
Chapter 34: Outcome Measures in Upper Limb Prosthetics
Tab le 2
Upper Limb Prosthetic Outcome Measures Designated
as Recommended for Use or Appropriate to Consider
Measures Recommended by the 2009 State of the Science Confer­ence or Later Recommended
Assessment of Capacity of Myoelectric
Control (pediatric and adult)
Canadian Occupational Performance
Measure (pediatric and adult)
Goal Attainment Scale (pediatric and
adult)
PODCI (pediatric) CAPP-PSI (pediatric)
PUFI (pediatric) Disabilities of the Arm, Shoulder and
Assisting Hand Assessment (pediatric) Southampton Hand Assessment
Diasbkids Questionnaire (pediatric) Sollerman Hand Function Test (pediatric
PedsQL (pediatrics) PUFI (adult)
World Health Organization Quality of Life
Assessment (adult)
Box and Blocks test (pediatric and adult) Patient-specic Functional Scale
Jebsen-Taylor Test of Hand Function
(adult)
Trinity Amputation and Prosthesis
Experience Scale (adult)
University of New Brunswick Test of Pros-
thetic Function (pediatric and adult)
AHA = Assisting Hand Assessment, CAPP-PSI = Child Amputee Prosthetics Project Prosthe­sis Satisfaction Inventory, PedsQL = Pediatric Quality of Life Inventory, PODCI = Pediatric Outcomes Data Collection Instrument, PUFI = Prosthetic Upper Extremity Functional Index, UBET = Unilateral Below Elbow Test, UEFS = Upper Extremity Functional Scale, UFI = Upper Extremity Functional Index.
prosthesis use on a 5-point scale, and it has been used in multiple studies.
4
The test is suitable for use in children aged 2 to 13 years; four age-based modules are designed to be developmentally appro­priate for children within a 3-year age range. The module for older children has been validated for adult use.14 No specific training is required to use this test, and the tasks require only easy-to-
Measures to Consider, as Designated by the 2009 State of the Science Conference
Children’s Hand-use Experience
Questionnaire (pediatric)
UFI (adult)
AHA-prosthetics (pediatric and adult)
Hand Outcome Measure (adult)
Procedure (adult)
and adult)
UBET (pediatric)
(pediatric and adult)
Orthotics and Prosthetics Users’
Survey-UEFS (adult)
limb prosthesis.
8,15
This easily admin­istered functional test evaluates gross manual dexterity. Patients are asked to transfer as many 1-inch blocks as possible over a divider from one side of a box to another, within a specified time period (Figure 2). No specialized training is required to administer the test, and the necessary equipment can be purchased or constructed.
obtain items.
Jebsen-Taylor Test of
Box and Block Test
The Box and Block test was recently val­idated for use in patients with an upper
Hand Function
The Jebsen-Taylor Test of Hand Function is a seven-part timed dexterity test and
has been validated in other disciplines.21 The tasks include writing, flipping in­dex cards, picking up small objects, spooning beans into a jar, stacking checkers, and moving light and heavy cans (Figure 3). Each task is timed separately. Recent validation work on the Jebsen-Taylor Test of Hand Func­tion (specific to prosthetics) resulted in modification to the scoring method of the original measure.15 Individuals us­ing this measure may want to investigate both the original and modified scoring methods to determine which is most appropriate for a specific application. No specialized training is required to administer the outcome measure, and the necessary equipment can be pur­chased or made.
Southampton Hand Assessment Procedure
The Southampton Hand Assessment Procedure was designed to evaluate the effectiveness of upper limb pros­theses, but it has not yet been validated because of funding difficulties and an insufficient population size necessary for validation; however, ongoing efforts are being made to achieve validation.9 Nonetheless, this measure has been widely used in recent prosthetic re­search. The tasks require manipulation of eight light or heavy objects (abstract tasks) and 14 simulated activities of daily living (Figure 4). The purpose is to evaluate hand function. Completion of the tasks is self-timed by the user, and scores are entered into a database that generates an overall index-of-function score. No specialized rater training is required, but the equipment must be rented or purchased from the University of Southampton, England, as a condi­tion of access to the database.
Trinity Amputation and Prosthesis Experience Scale
The Trinity Amputation and Prosthesis Experience Scale is a self-administered measure originally designed to assess a
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
423
Section 2: Upper Limb
user’s adaptation to lower limb ampu­tation and prosthesis use. Its scope has been expanded to upper limb prosthesis users. The self-reported questionnaire has 54 items. Nine subscales assess adjustment to prosthesis use (general adjustment, social adjustment, and ad­justment to limitations), activity restric­tion (restriction of functional, social, and athletic activities), and user satis­faction with the prosthesis (satisfaction with weight, function, and aesthetic appearance).22 The user satisfaction subscales have been validated for upper limb prosthesis use.15 This measure can be used to evaluate psychosocial topics such as pain, perceived social reaction, and satisfaction that are not included in other functional measures.
22
Evaluation of User and Clinician Goals
The Patient-Specific Functional Scale, the Canadian Occupational Performance Measure, and the Goal Attainment Scale evaluate progress toward goals set by the user and the clinician. One of these measures may be more appropriate than another for a specific application. The Patient-Specific Functional Scale is the simplest of the three measures to admin ister. The user identifies five tasks per­ceived to be difficult and rates limitation in performing each task on a 10-point scale (range, 0 = unable to perform, 10 = no difficulty in performing).23 The Canadian Occupational Performance Measure is slightly more complex. The user identifies goals in self-care, pro­ductivity, and leisure, which are rated in terms of importance, user perception of performance, and satisfaction with performance.
24,25
The Goal Attainment Scale originally was developed for use in mental health settings and is the most complicated of the three measures to score. Five outcome levels are set for each goal and are reassessed at prede­termined times to determine progress toward achieving the goal.
24
Figure 2
and Block test.
Photograph showing a man with an upper limb prosthesis participating in the Box
-
Figure 3
Function.
Photograph showing the small objects test of the Jebsen-Taylor Test of Hand
Other Measures of Interest
Although the Hanspal Socket Comfort Score is not specifically validated for upper limb prosthetics, it is an easily administered outcome measure that has been generally validated for prosthesis
users.26 Because of the importance of socket comfort in the successful fitting and use of a prosthesis, this outcome measure may be useful in evaluating new socket technology or socket de­sign in a clinical or research setting.
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Chapter 34: Outcome Measures in Upper Limb Prosthetics
Figure 4
abstract object task). B, Removing a jar lid (an activity of daily living task).
The Orthotics and Prosthetics Users’ Survey has two satisfaction subscales, Satisfaction with Care and Satisfaction
Photographs showing two tasks from the Southampton Hand Assessment Procedure. A, Moving a lightweight cylindrical object (an
therapist. A team approach is likely to improve overall outcomes and enhance
the benefit to patients. with Device, both of which have been validated for independent use and may be useful in the clinical environment.
Summary
12
As prosthetic componentry continues
to evolve, so do the tools for assessing
Discussion
Some outcome measures are appropri­ate for use in both the research and pa­tient-care settings, but there is no single benchmark outcome measure. The re­search question must be framed before selecting appropriate outcome measures from a toolbox of recommended mea­sures. Multiple sources are available to assist in selecting an appropriate tool; however, further research is needed to determine which measures are suffi-
the effectiveness and use of devices.
Clinicians who need to evaluate up-
per limb prosthesis function should
continue to review the literature. New
measures are likely to be developed,
and existing measures will continue to
be vali dated for use in individuals with
an upper limb amputation. As research
pro gresses, it will be possible to answer
increasingly more complex research
questions through longitudinal studies
involving large populations. ciently sensitive to evaluate users’ ulti­mate acceptance or rejection of a specific prosthesis design.
3,4 ,6,7, 13,1 5,17, 24,2 7,28
If no fully validated outcome measure exists, other measures are available that have been deemed worthy of consideration by experts in the field. The use of many of the recommended measures may re­quire the involvement of an occupa tional
Acknowledgments
The recent work on upper limb pros­thetic outcome measures has been a group effort of occupational therapists, engineers, physicians, and prosthetists. The author would like to acknowledge the dedicated work of the ULPOM vol­unteer group, participants in the State
of the Science Conferences, and funding agencies that have supported the efforts of the many investigators who are work­ing to establish strong, clinically valid outcome measures for users of upper limb prostheses.
References
1. Wade DT: Assessment, measurement and data collection tools. Clin Rehabil 2004;18(3):233-237. Medline DOI
2. Roach KE: Measurement of health outcomes: Reliability, validity, and responsiveness. J Prosthet Orthot 2006:P8-P12. DOI
3. Wright V: Measurement of functional outcome with individuals who use upper extremity prosthetic devices: Current and future directions. J Pros- thet Orthot 2006;18:46-56. DOI
4. Wright V: Prosthetic outcome measures for use with upper limb amputees: A systematic review of the peer-reviewed literature, 1970 to
2009. J Prosthet Orthot 2009;21(9):P3­P63. DOI
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5. Hubbard S: Pediatric upper limb out­come measurement. J Prosthet Orthot 2009;21(9):P64-P68. DOI
6. Hill W, Stavdahl O, Hermansson LN, et al: Functional outcomes in the WHO-ICF model: Establishment of the Upper Limb Prosthetic Outcome Measures Group. J Prosthet Orthot 20 09;21:115-119. DOI
7. Hill W, Kyberd P, Hermansson LN, et al: Upper Limb Prosthetic Outcome Measures (ULPOM): A working group and their ndings. J Prosthet Orthot 2009;21(9):P69-P82 .
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8. Mathiowetz V, Volland G, Kashman N, Weber K: Adult norms for the Box and Block test of manual dexterity. Am J Occup er 1985;39(6):386-391.
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9. Light CM, Chappell PH, Kyberd PJ: Establishing a standardized clinical assessment tool of pathologic and prosthetic hand function: Normative data, reliability, and validity. Arch Phys Med Rehabil 2002;83(6):776-783.
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10. Hermansson LM, Fisher AG, Ber­nspång B, Eliasson AC: Assessment of Capacity for Myoelectric Control: A new Rasch-built measure of pros­thetic hand control. J Rehabil Med 20 05;37(3):166-171. Medline
11. Burger H, Franchignoni F, Heine­mann AW, Kotnik S, Giordano A: Validation of the Orthotics and Pros­thetics User Survey upper extremity functional status module in people with unilateral upper limb amputa­tion. J Rehabil Med 2008;40(5):393-
399. Medline DOI
12. Heinemann AW, Bode RK, O’Reilly C: Development and measurement properties of the Orthotics and Pros­thetics Users’ Survey (OPUS): A com­prehensive set of clinical outcome
instruments. Prosthet Orthot Int 2003;27(3):191-206. Medline DOI
13. Miller LA, Swanson S: Summary and recommendations of the Academy’s State of the Science Conference on Upper Limb Prosthetic Out­come Measures. J Prosthet Orthot 2009;21(9):P83-P89. DOI
14. Resnik L, Baxter K, Borgia M, Mathewson K: Is the UNB test reliable and valid for use with adults with upper limb amputation? J Hand er 2013;26(4):353-359.
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15. Resnik L, Borgia M: Reliability and validity of outcome measures for upper limb amputation. J Prosthet Orthot 2012;24:192-201. DOI
16. Resnik L, Adams L, Borgia M, et al: Development and evaluation of the Activities Measure for Upper Limb Amputees. Arch Phys Med Rehabil 2013;94(3):488-494.e4.
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17. e Management of Upper Extremity Amputation Rehabilitation Working Group: VA/DoD clinical practice guideline for the management of upper extremity amputation reha­bilitation. Appendix C (pp 107-113). Available at: http://www.healthqual-
ity.va.gov/guidelines/Rehab/UEAR/ VADoDCPGManagementofUEAR­121614Corrected508.pdf. Accessed
March 13, 2015.
18. Hermansson LM, Bodin L, Eliasson AC: Intra- and inter-rater reliability of the Assessment of Capacity for Myoelectric Control. J Rehabil Med 2006;38(2):118-123. Medline DOI
19. Lindner HY, Eliasson AC, Hermans­son LM: Inuence of standardized activities on validity of Assessment of Capacity for Myoelectric Control. J Rehabil Res Dev 2013;50(10):1391­140 0. Medline DOI
20. Sanderson ER, Scott RN: UNB Test of
Prosthetics Function: A Test for Uni­lateral Upper Extremity Amputees, Ages 2-13. Fredericton, New Bruns-
wick, University of New Brunswick Bioengineering Institute, 1985.
21. Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA: An ob­jective and standardized test of hand function. Arch Phys Med Rehabil 1969;50(6):311-319. Medline
22. Desmond DM, MacLachlan M: Fac­tor structure of the Trinity Amputa­tion and Prosthesis Experience Scales (TAPES) with individuals with ac­quired upper limb amputations. Am J Phys Med Rehabil 2005;84(7):506-
513. Medline DOI
23. Stratford P: Assessing disability and change on individual patients: A report of a patient specic measure. Physiother Can 1995;47:258-263. DOI
24. Donnelly C, Carswell A: Individu­alized outcome measures: A review of the literature. Can J Occup er 2002;69(2):84-94. Medline DOI
25. Law M, Baptiste S, Carswell A, Mc­Coll MA, Polatajko H, Pollock N: e
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da: CAOT Publications ACE, 1998.
26. Hanspal RS, Fisher K, Nieveen R: Prosthetic socket t comfort score. Disabil Rehabil 2003;25(22):1278-
1280. Medline DOI
27. Biddiss E, Chau T: Upper-limb prosthetics: Critical factors in device abandonment. Am J Phys Med Rehabil 2007;86(12):977-987.
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Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
426
Atlas of
Amputations and
Limb Deficiencies
Atlas of
Amputations and
Limb Deficiencies
Surgical, Prosthetic, and Rehabilitation Principles
Fourth Edition
Volume 2
Lower Limb Management Issues
Editors
Joseph Ivan Krajbich, MD Michael S. Pinzur, MD LTC Benjamin K. Potter, MD Phillip M. Stevens, MEd, CPO
Section 3Section 3
Lower Limb
Chapter 35
Lower Limb Prosthetic Components: Updated Classication and Passive, Body-Powered Components
John W. Michael, MEd, CPO, FAAOP Phillip M. Stevens, MEd, CPO, FAAOP
Abstract
e range of commercially available lower limb prosthetic components continues to ex­pand. e selection of appropriate components is made easier through the classication of components according to their design and function. is classication process begins with delineations between passive, body-powered components; the use of microprocessor control; and the more recent development of active, externally powered components. It is helpful to be familiar with the classication of current passive, body-powered prosthetic foot/ankle units and passive, body-powered knee systems.
Keywords: lower limb prosthesis; prosthetic components; prosthetic feet; prosthetic knees
Introduction
The range of commercially available lower limb prosthetic components con­tinues to expand with each passing year. Although this expansion offers patients and their rehabilitation teams greater selection in prosthetic options, the num­ber of choices may be overwhelming if these options are not grouped into a log­ical classification scheme. The purpose of this chapter is to propose a classifi­cation method that reasonably captures the current diverse range of lower limb prosthetic components. The chapter also will address those components that can be reasonably described as passive, body-powered devices.
Classification Considerations
The clinical classification of prosthet­ic components for prescription and
teaching purposes has continually evolved as available technology has advanced. In 1965, Earl Lewis1 noted the following: “The relatively recent introduction of fluid-controlled knee mechanisms…has raised a number of important considerations for clinicians.” After explaining the biomechanics be­hind the higher level of performance of cadence-responsive hydraulic and pneu­matic knees, Lewis suggested the follow­ing: “The prescription process may have to consider these two levels of perfor­mance.” The now widely accepted divi­sion of prosthetic knee components into those with purely mechanical friction versus those offering velocity-responsive fluid damping reflects these insights.
In recent decades,2 worldwide ac­ceptance of microprocessor-controlled (MPC) lower limb components suggests that it may now be useful to expand the
clinical classification to reflect contem­porary advancements in function and control for lower limb devices. Torrealba et al3 proposed adding the concepts of active movement and microprocessor control to better characterize currently available prosthetic knee components.
Mechanically Passive Devices
Prior to 2006, all commercially avail­able lower limb prosthetic components, including MPC knees at that time, were mechanically passive (the wearer’s phys­ical effort during ambulation causes mo­tion). Applying an analogy from upper limb prosthetics, these are body-pow­ered designs, where all energy input comes from the user’s force generation, momentum, body weight, and similar internal activation sources.
For example, flexion and extension of the prosthetic knee joint occurs when the transfemoral residual limb moves the socket by means of hip joint motion. The necessary compensations to induce such motion—using the residual limb, more proximal joints, the contralateral leg, and the head/arms/trunk—have been well documented4 and are be­lieved to contribute to gait inefficiency that progressively increases with more proximal levels of amputation.5 Experts also are increasingly cognizant of the strain such compensations place on the individual and the increased risk of overuse syndromes.
6
Mr. Stevens or an immediate family member serves as a paid consultant to or is an employee of Hanger Clinic and serve s as a board member, owner, ocer, or committee member of the Amer ican Academy of Orthotists and Prosthetists. Neither Mr. Michael nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this chapter.
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
MPC Devices
Lower limb prosthetic components with MPC activation have been com­mercially available since the release of
429
Section 3: Lower Limb
Tab le 1
Classifying Lower Limb Prosthetic Components
Into Functionally Similar Performance Categories
Design Characteristics Historic Methods Modern Methods
Movement damping Mechanical friction Fluid friction (1960)
Control method Mechanical design Microprocessor controlled
Movement generation Passive (body-
Force generation (during
ambulation)
a
Components with these design features generally result in a more normal gait pattern during
ambulation with a prosthesis than components without these features.
b
Date of the rst commercially available product in the United States.
the Intelligent Prosthesis (Blatchford & Sons) in 1990 and have been shown to offer clinical advantages compared with mechanically controlled alterna-
2,7
tives.
However, most MPC knees sim-
powered)
Apropulsive Propulsive (2006)
muscle contractions to move a lower limb device. Applying an analogy from upper limb prosthetics, this was the first example of an externally powered lower limb component.
b
(199 0)
Active-external power (2006)
a
b
b
ply dampen motion by using software algorithms, which has a modest effect on gait efficiency. For example, the original Blatchford Intelligent Prosthesis used its microprocessor to vary only pneu­matic swing phase flexion resistance.8 The clinical use of MPC knees became more widespread after the C-Leg (Ot­tobock) added effective MPC hydraulic stance stability damping in addition to MPC hydraulic swing phase flexion and extension damping.9 Since then, addi­tional passive MPC prosthetic knees have become available, and the benefits of simulating eccentric muscle control during gait in this manner have been reported.
2,10
Force Generation
In 2006, the Power Knee (Össur) was released. This knee is capable of flexing and extending the prosthetic knee joint during the stance and swing phases. This was the first available component that generated sufficient force to active­ly raise a user’s center of mass during normal activities of daily living, such as ramp and stair descent.
12
More recently, BiOM released a pow­ered ankle-foot system that generates enough force to actively propel a us­er’s center of mass during ambulation. Preliminary studies suggest that gen­erating forces of this magnitude at the ankle during stance can increase gait
Active Lower Limb Devices
In 2006, Össur released the first me­chanically active lower limb prosthetic
efficiency with a prosthesis considerably more effectively than was previously possible.
13
component: an MPC component with a motor powerful enough to move the joint in the sagittal plane during the swing phase. The Proprio ankle/foot system (Össur) changes the plantar-dorsiflexion position of a carbon fiber foot during the swing phase to enhance gait me­chanics and safety for the wearer.11 For the first time, a commercially available component could simulate concentric
Categorization Proposal
Design improvements since 1960 re­quire modifications in the categoriza­tion of lower limb components to reflect the substantial biomechanical improve­ments resulting from major technolog­ic advances. In addition to the familiar classification of mechanical components according to whether they include fluid
control, today’s clinician must consider the growing number of MPC prosthe­ses and the potentially higher function they can provide. Although most lower limb components are currently passive devices, the recent availability of active devices that simulate concentric mus-
a
cle control opens up new possibilities for reducing the effects of lower limb amputation on human function. Those components with sufficient power to add meaningful propulsion to gait seem particularly promising and warrant fur­ther clinical application and research investigation.
Table 1 shows the proposed clinical categorization of lower limb prosthetic components. This chapter focuses only on the pre-MPC era of mechanical and fluid-controlled components.
Passive, Body-Powered Prosthetic Ankle­Foot Mechanisms
Passive ankle-foot mechanisms that are controlled only by their mechanical de­sign have been historically classified into a few conceptual groups based on their overall biomechanical performance (Ta- ble 2). Research consistently documents that these components result in an ap­ropulsive gait characterized by a lack of ankle power generation in late stance. This simplified classification remains useful because the numerous com­mercially available components within each conceptual group have very similar indications and limitations, making it relatively easy to rule out poor choices and generate a functionally appropriate prescription recommendation.
Solid Ankle Cushion Heel Foot
The Solid Ankle Cushion Heel (SACH) foot has the most biomechanically simple design. With its nonarticulated ankle and the lack of complex inter­nal parts, it is one of the lightest, low­est cost, and most durable options for limited household ambulators. In the United States, Medicare recognizes the
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