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1/3/2015 StateoftheScience Review of Transtibial Prosthesis Alignment Perturbation Journal of Prosthetics and Orthotics, 2009 | American Academy of Orthoti… http://www.oandp.org/jpo/library/2009_04_175.asp 1/14 American Academy of Orthotists & Prosthetists Professionals Advancing Care Through Knowledge You are here: Home > Publications > JPO > 2009 Vol. 21, Num. 4 > pp. 175193 StateoftheScience Review of Transtibial Prosthesis Alignment Perturbation Edward S. Neumann, PhD, PE, CP, FAAOP Take Online Quiz for PCEs ABSTRACT A systematic review of research on the effects of transtibial prosthesis alignment perturbation on gait was carried out following guidelines prepared by the American Academy of Orthotists and Prosthetists. Approximately 278 references published since 1973 were obtained by searching key data bases and then screened for relevance, resulting in 34 published research articles, which were evaluated for internal and external validity using published criteria and assigned ratings of high, moderate, or low. A matrix was developed that classified the 34 articles by the type of alignment perturbations undertaken and the outcome measures used. The matrix used eight categories of perturbations and 43 distinct outcomes measures related to the total body, gait symmetry, EMG and oxygen consumption, and kinematic and kinetic measurements of the prosthetic and contralateral limb. These articles were used to generate 113 evidence statements pertaining to the effect of alignment perturbation on gait. Each of the statements was assigned a confidence rating of high, moderate, low, or insufficient evidence based on the volume and quality of the published evidence. Fortythree statements judged to have high or moderate levels of confidence associated with them are presented and discussed, along with recommendations concerning future research on alignment perturbation studies.( J Prosthet Orthot . 2009;21:175–193. ) Systematic reviews of the quality of the scientific literature in specific domains of medical knowledge are growing in importance. The motivation for this is to improve clinical decision making through application of the principles of evidencebased practice, which require an assessment of available scientific evidence. The American Academy of Orthotists and Prosthetists has developed guidelines for developing StateoftheScience Evidence Reports, which assess the value of the scientific literature for orthotic and prosthetic clinical practice. 1 The methodology of the assessment involves the development of clinically relevant questions, which are reformulated as statements in a style similar to hypotheses, followed by a search of literature databases for potentially relevant articles. Criteria of inclusion and exclusion are used to narrow the potential articles down to just those that facilitate an assessment of the overall quality of the evidence, which exists to support the statements. Each article is evaluated individually with respect to a set of internal and external validity criteria. The statements are then assigned an overall confidence rating based on the number and quality of the individual studies. The criteria help to minimize the subjectivity in assessing the articles, but the judgment of the evaluators still enters the process, particularly in the assignment of confidence levels to the statements. A secondary goal of the guidelines is to identify gaps and shortcomings in existing research, so that scientists can improve

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  • 1/3/2015 StateoftheScienceReviewofTranstibialProsthesisAlignmentPerturbationJournalofProstheticsandOrthotics,2009|AmericanAcademyofOrthoti

    http://www.oandp.org/jpo/library/2009_04_175.asp 1/14

    AmericanAcademyofOrthotists&ProsthetistsProfessionalsAdvancingCareThroughKnowledge

    Youarehere: Home>Publications>JPO>2009Vol.21,Num.4>pp.175193

    StateoftheScienceReviewofTranstibialProsthesisAlignmentPerturbation

    EdwardS.Neumann,PhD,PE,CP,FAAOP

    TakeOnlineQuizforPCEs

    ABSTRACT

    AsystematicreviewofresearchontheeffectsoftranstibialprosthesisalignmentperturbationongaitwascarriedoutfollowingguidelinespreparedbytheAmericanAcademyofOrthotistsandProsthetists.Approximately278referencespublishedsince1973wereobtainedbysearchingkeydatabasesandthenscreenedforrelevance,resultingin34publishedresearcharticles,whichwereevaluatedforinternalandexternalvalidityusingpublishedcriteriaandassignedratingsofhigh,moderate,orlow.Amatrixwasdevelopedthatclassifiedthe34articlesbythetypeofalignmentperturbationsundertakenandtheoutcomemeasuresused.Thematrixusedeightcategoriesofperturbationsand43distinctoutcomesmeasuresrelatedtothetotalbody,gaitsymmetry,EMGandoxygenconsumption,andkinematicandkineticmeasurementsoftheprostheticandcontralaterallimb.Thesearticleswereusedtogenerate113evidencestatementspertainingtotheeffectofalignmentperturbationongait.Eachofthestatementswasassignedaconfidenceratingofhigh,moderate,low,orinsufficientevidencebasedonthevolumeandqualityofthepublishedevidence.Fortythreestatementsjudgedtohavehighormoderatelevelsofconfidenceassociatedwiththemarepresentedanddiscussed,alongwithrecommendationsconcerningfutureresearchonalignmentperturbationstudies.(JProsthetOrthot.200921:175193.)

    Systematicreviewsofthequalityofthescientificliteratureinspecificdomainsofmedicalknowledgearegrowinginimportance.Themotivationforthisistoimproveclinicaldecisionmakingthroughapplicationoftheprinciplesofevidencebasedpractice,whichrequireanassessmentofavailablescientificevidence.TheAmericanAcademyofOrthotistsandProsthetistshasdevelopedguidelinesfordevelopingStateoftheScienceEvidenceReports,whichassessthevalueofthescientificliteraturefororthoticandprostheticclinicalpractice.1Themethodologyoftheassessmentinvolvesthedevelopmentofclinicallyrelevantquestions,whicharereformulatedasstatementsinastylesimilartohypotheses,followedbyasearchofliteraturedatabasesforpotentiallyrelevantarticles.Criteriaofinclusionandexclusionareusedtonarrowthepotentialarticlesdowntojustthosethatfacilitateanassessmentoftheoverallqualityoftheevidence,whichexiststosupportthestatements.Eacharticleisevaluatedindividuallywithrespecttoasetofinternalandexternalvaliditycriteria.Thestatementsarethenassignedanoverallconfidenceratingbasedonthenumberandqualityoftheindividualstudies.Thecriteriahelptominimizethesubjectivityinassessingthearticles,butthejudgmentoftheevaluatorsstillenterstheprocess,particularlyintheassignmentofconfidencelevelstothestatements.Asecondarygoaloftheguidelinesistoidentifygapsandshortcomingsinexistingresearch,sothatscientistscanimprove

  • 1/3/2015 StateoftheScienceReviewofTranstibialProsthesisAlignmentPerturbationJournalofProstheticsandOrthotics,2009|AmericanAcademyofOrthoti

    http://www.oandp.org/jpo/library/2009_04_175.asp 2/14

    thedesignoffutureexperiments.Thefirstapplicationoftheguidelineswasforpartialfootamputations.2ThestudyreportedhereappliestheguidelinestoareviewoftheresearchthathasbeenconductedonthealignmentoftranstibialprosthesesandcitedindatabasesthroughJanuaryof2008.

    Benchalignmentistheinitialalignmentproducedduringprosthesisfabricationbeforeitisplacedonthepatient,andoftenfollowsguidelinesestablishedandprovidedbythemanufacturersofprostheticfeetandknees.Staticalignmentisundertakenwiththeprosthesisonthepatientandsomeweightbearing,andoccursbeforewalking.Itofteninvolvesexaminationandcorrectionofpylonheightandgeneralalignmentoftheprostheticcomponents.Dynamicalignmentfollowsandinvolveshavingthepatientwalkwiththeprosthesis.Avarietyofgaitcharacteristicsareexaminedbyobservingthepatientandaskingthepatienttoreportwhetherthealignmentproducessensationsthatmayindicatemisalignment.Thisreviewfocusesonstaticanddynamicalignment.Manufacturerrecommendationsconcerningbenchalignmentwerenotreviewed.

    METHODS

    INCLUSIONCRITERIATobeincluded,articleshadtobepublishedinEnglish,examinetheeffectsofperturbationsoftranstibialprosthesesasaprimaryorsecondaryresearchgoal,describetheperturbationsquantitatively,andreportresultsquantitatively.Articlesconcerninginstrumentationformeasuringalignmentoralignmentperturbationsalsowerereviewed,buttheywereexcludediftheyfailedtoincludedataonperturbationoutcomes.Becauseoftherelativescarcityofstudiesonalignmentperturbation,testsofstatisticalsignificancewerenotarequirementforinclusion.However,lackoftestsofstatisticalsignificanceloweredconfidenceinthequalityoftheevidenceirrespectiveofthemagnitudesofthedifferencesinoutcomesbetweentheacceptableandperturbedalignments.Similarly,failuretopresentdataintablesthatpermittedinspectionoftheactualreportedvaluesalsoloweredconfidenceinthequalityoftheevidence.Articlesinconferenceproceedingsandalimitednumberofabstractswereincludediftheymettheinclusioncriteria.Foranabstractorpostertobeincluded,ithadtoidentifyperturbationsandreportoutcomesinsufficientdetailtobeusefulfordevelopingevidencestatements.

    EXCLUSIONCRITERIAArticlesinlanguagesotherthanEnglishwereexcluded.Articlesthatexaminedamputeegaitbutdidnotexaminetheeffectsofalignmentperturbationwereexcluded.Articlesthatexaminedjusttransfemoralprosthesisalignmentwereexcluded.Nodissertationswereincluded.Itwasassumedthattheresultsofdissertationswouldbepublishedbytheauthor.ArticlesthatcouldnotbelocatedthroughthelibraryservicesattheUniversityofNevada,LasVegas,despitefullcitationsforthem,wereexcluded.Articleswerenotexcludedbecauseofageorsmallsubjectsamplesizes.

    SearcheswereundertakenusingtheRECAL,RECALLegacy,MEDLINE,WebOKnowledge,CochraneReviews(WileyInterScience),CINHAL,andScienceDirectdatabases.TheRECALdatabasewasusedtoproducetheinitiallistofpublications,andtheotherdatabaseswereusedtoaugmentthelistwitharticlesnotindexedintheRECALdatabase.Byusingthewords"prosthesisalignment,"33referenceswereobtainedfromtheRECALdatabase,butseparatingthesearchtermintothetwowords"prosthesis"and"alignment,"thenumberofreferencesincreasedto278,andthisbecametheinitiallisttowhichadditionalreferenceswereadded.TheRECALLegacydatabaseproducedonly36referencesusingthewords"prosthesisalignment,"noneofwhichwerenew.AMEDLINEsearchwasundertakenusingtheterms([topic=artificiallimborMeSHheading:exp=artificiallimbs]andtopic=alignment),whichproduced81references,severalofwhichwerenew.AsearchoftheCochraneReviewsrevealedthat

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    nonehadbeenconductedonthealignmentofexternallimbprostheses.CINHALproduced18resultsusingtheterms(["prosthesis"and"alignment"]andDE"LimbProsthesis"),noneofwhichwerenew.ScienceDirectproduced16referencesusingthekeywords"amputee"and"alignment,"severalofwhichwerenewbecausetheywerestillinpressorjustrecentlypublished.

    TheexpandedRECALlistoftitleswasexaminedforrelevancytotranstibialprosthesisalignment,whichnarrowedthelistdownto55articles.Applicationoftheinclusionandexclusioncriteriafurthernarrowedthelistdownto34articles,whichwerereviewedindetail.Thirtyonewereclassifiedascontrolledbeforeandaftertrials,onewasconsideredtobeacrosssectionalstudy,andtwowereclassifiedascaseseries.NineofthearticleshadappearedinProstheticsandOrthoticsInternational,fourintheJournalofRehabilitationResearchandDevelopment,andthreeeachinGait&Posture,ClinicalBiomechanics,andIEEEConferenceProceedings.TwoappearedintheTransactionsoftheASMEJournalofBiomechanicalEngineering,andtheremainingarticlesweresinglepublicationsinavarietyofjournalsorconferenceproceedings.Thenumberofarticlesontranstibialalignmentincreasedineachofthedecadessince1970to1979,whenonlyonemeetingtheinclusioncriteriawaslocated.From1980through1989,sixarticleswerelocated,from1990through1999,13articleswerelocated,andfrom2000tothetimethisreviewwasbeguninJanuaryof2008,14articlesmeetingtheinclusioncriteriawerelocated.

    Forthereview,eightalignmentperturbationvariablesweredefinedastypicallyusedinO&Pacademicprogramsandbypracticingclinicians.Thesevariablesincludedsocketflexionextensionwithrespecttothepylon(rotatingthebrimanteriororposterior,respectively),socketabductionadductionwithrespecttothepylon(rotatingthebrimmedialorlateral,respectively),footanteriorposteriortranslationwithrespecttothesocket,footmediallateraltranslationwithrespecttothesocket,footplantarflexiondorsiflexionwithrespecttotheankle,footinversioneversionwithrespecttheankle,footinternalexternalrotationwithrespecttothesocket,andpylonheight(length).

    OUTCOMEMEASURECLASSIFICATIONAvarietyofoutcomemeasureswerereportedinthereviewedpublications.Aclassificationhierarchywasdeveloped,which,atthefirstlevel,classifiedandmadedistinctionsamongstudiesthatexaminedoutcomesrelatedtothetotalbody(I,totalbodymeasures),bothlimbs(II,bilateralcomparisons),andtheprostheticlimb(III,prostheticlimb).Totalbodymeasures(I)studiesexaminedthesubjectiveacceptabilityofalignment,oxygenuptake,totalbodyandjointworkorenergy,walkingspeed,andcadence.Bilateralcomparisons(II)studiescomparedtheprostheticandcontralaterallimbsorexaminedmeasuresofsymmetry.CategoryIIIstudiespresentedoutcomesfortheprostheticlimb.Inmanycases,studieswereassignedtomultiplecategoriesiftheevidencehadbeenexaminedfrommultipleperspectives.

    Thesecondlevelofthehierarchyclassifiedstudiesbyoutcomevariable.Thebroadcategoriesofoutcomevariablesweregaittemporalspatialcharacteristics(phaseduration,steplengthorstrideduration),electromyogram(EMG)activity,groundreactionforceorpylonforce(extremespeakmagnitudes,extremestiming,impulse,centerofpressuretrajectory,orlocation),jointkinematics(rangeofmotion.ROM./peakangles,peakangletiming,andangularvelocity),jointkinetics(moment,impulse,power,andwork),andintrasocketforces(normalpressures,shearforces).Theintrasocketforcesubcategoriesofnormalpressureandshearforces,whichwereapplicableonlytotheprostheticlimb,werefurtherdividedintothefollowingcategories:extremesmagnitude,extremestiming,patterns/durations,andimpulse.A344cellmatrixwasdevelopedwiththeeightperturbationvariablesrepresentedbycolumnsandthe43outcomesmeasuresrepresentedbyrows.Thematrixwasusedtoclassifythestudies.Figure1indicatestherelationshipsamongthesevariablesandshowsthatmanyoftheoutcomesmeasureswerederivedfrommodelsandbasedondatacollectedusingcomplexinstrumentationinalaboratorysetting.

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    http://www.oandp.org/jpo/library/2009_04_175.asp 4/14

    CRITERIAFORASSESSINGINTERNALANDEXTERNALVALIDITYTheAmericanAcademyofOrthotistsandProsthetistshasdevelopedalistofthreatstointernalandexternalvalidityforuseinpreparingStateoftheScienceEvidenceReports.1Thethreatsinthislistaregeneralandwereexpandedforuseinthisassessment(AppendixA).Theexpandedcriteriareflectspecificthreatstothevalidityofresearchstudiesonalignmentperturbationsandweredevelopedduringapreliminaryreviewofthe34researcharticlesselectedforpreparationoftheevidencetables.Eachofthestudieswasassignedalow,moderate,orhighlevelofconfidenceforinternalandexternalvalidityusingthesecriteria.Table1summarizesthekeycriteria.TheresultsfortheindividualarticlesareinAppendixB.

    Ifastudyfailedtoreportthepresenceorabsenceofstatisticalsignificancewithrespecttoanoutcome,itwasautomaticallyassignedalowlevelofconfidenceforinternalvalidity.Toachieveamoderateratingforinternalvalidity,testsofstatisticalsignificancehadtobepresent,anddatahadtobedescribedsufficiently(i.e.,meansandvariances)topermitresultstobecomparedwithsimilarstudies.Toachieveahighratingforinternalvalidity,samplesizehadtobegreaterthan5toensurethatindividualtoindividualvariabilitywasnotinfluencingtheresults,andthatthepresenceorabsenceofcauseandeffectwasbeingdemonstrated.Threatcriteriauniquetoexternalvalidityincluded,amongotherthings,useofsolidanklecushionedheel(SACH)feetandpatellartendonbearing(PTB)sockets,lackofanadequatedescriptionoftheperturbations,failuretointerpretfindingswithrespecttoclinicalrelevance,failuretointerpretresultsinthecontextoftheexistingliterature,andtheappearanceofpotentialconflictsofinterest.ThepervasiveuseinthestudiesofSACHfeetandtraditionalPTBsocketsfeaturingPelitelinerswerenotareasonfordowngradingstudies,althoughthesemaylimittheextenttowhichgeneralizationscanbemade.Becauseevidencehasnotbeendevelopedtoeithersubstantiateorrefutetheseconcerns,studieswerenotdowngraded.

    Outcomesthatweresubjectspecificalsorepresentedapotentialthreattoexternalvalidity.However,outcomeshighlydependentonuniqueaspectsoftheresearchsubjectmaybearealityforsomealignmentphenomena.Forexample,socketintrapressureperceptionsandmeasurementsmightbesubjectspecificbecauseofpotentiallylargevariationsamongamputeeswithrespecttoresiduallimbmorphology,amputeesignaldetectionsensitivities,socketdesigns,andqualityofsocketfit.Inrecognitionofthis,studiesreportingresultsforsinglesubjectsthatwereconsistentwithrecognizedbiomechanicalprinciplesandtheorywerenotautomaticallydowngraded.

    Ifastudyfindingdemonstratedagreementwithbiomechanicalprinciplesandtheory,theauthordevelopedanexternalvalidityratingforitbasedonitspotentialusefulnessindevelopingevidencetables.Forexample,ifthestudylackedtestsofstatisticalsignificance,butresultsseemedtobeinagreementwithstudiesthatdidundertaketestsofstatisticalsignificance,oriftheyseemedtoagreewithanumberofotherstudiesofsimilarinternalvalidity,itmayhavereceivedahigherratingforexternalvaliditythanforinternalvalidity.Thus,studiesreceivingaratingofLowoninternalvaliditycouldreceiveratingsofmoderateonexternalvalidity.However,nostudyreceivingaratingoflowoninternalvaliditycouldbeassignedaratingofhighonexternalvalidity.Studiesreceivingaratingofhighoninternalvaliditycouldreceiveamoderateratingwithrespecttoexternalvalidityifthesubjectsseemedtohaveuniquecharacteristicsthatcouldlimitgeneralizations,orifthenumberofsubjectswassmall.

    EVIDENCESTATEMENTSFortheevidencestatements,theword"Confidence"wasusedtoindicatethelevelofassuranceonecouldplaceinitstruth.ThecriteriadefiningeachoftheselevelsarepresentedinTable2.Foranevidencestatementtobeassignedahighlevelofconfidence,itwasnecessarythatatleasttwoorthreestudieswithhighexternalvalidityratingsandoutcomesagreedwiththestatements,oralargernumberofstudieswithmoderateexternalvalidityratingsandoutcomesagreedwiththestatement.Tobeassignedamoderatelevelofconfidence,itwasnecessarythatatleastonestudywithhighexternalvalidityratings

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    andoutcomesagreedwiththeevidencestatement,oratleasttwostudieswithmoderatelevelsofexternalvalidityagreedwiththeevidencestatement.Tobeassignedaninsufficientevidencelevelofconfidence,itwasnecessarytofindatleastonestudywithamoderatelevelofexternalvalidity,ormultiplestudieswithlowexternalvalidity,whichagreedwiththeevidencestatement,ormultiplestudieswithmoderateorlowlevelsofexternalvaliditythatcametocontradictoryconclusions.Ratinganevidencestatementashavingalowlevelofconfidenceindicatedthatevidenceexistedwhichrefutedthestatement,ortherewereobviousandseriousshortcomingsinthestudydesign,andonecouldplacenoassuranceintheresults.Inotherwords,alowlevelofconfidenceimpliedthattherecouldbeagreaterprobabilitythatthestatementisfalsethanthatitistrue.

    RESULTS

    Tabel4indentifiesthe34articlesreviewedindetail,indicatingthetypeofstudy,thenumberofsubjectsincludedinthestudy,whetherstatisticaltestsofsignificancewereundertaken,andtheratingsassignedforinternalandexternalvalidity.Withrespecttointernalvalidity,sevenarticleswereratedhigh,10wereratedmoderate,and17wereratedlow.Withrespecttoexternalvalidity,fivearticleswereratedhigh,26wereratedmoderate,andthreewereratedlow.

    Theresulting344cellclassificationmatrixisshowninTable4.Eachofthe34articlesexaminedindetailappearatleastonceinthematrix.Manyofthecellsareempty,indicatingthatnostudiesfeaturedthatparticularcombinationofperturbationandoutcomemeasure.Afewofthecellsarerepresentedbyasmanyaseightstudies.Manyofthestudiesareenteredinmorethanonecellbecauseoftheiruseofmultipleperturbationsoroutcomesmeasures.Manyofthenonemptycellshaveonlyoneortwoentries,indicatinghowdiffusepublishedresearchonalignmenthasbeen.

    Symbolsusedinthetableindicateseveralimportantcharacteristicsofeachstudy.Areferenceinboldindicatesthattestsofstatisticalsignificancewereundertakenwithrespecttothealignmentvariableandoutcomemeasure.Studiesvariedinthereportingofsignificance.Manyusedp

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    DISCUSSION

    STUDYTYPEANDDESIGNResearchinvolvingperturbationsinthesagittalplane(socketflexionextensionorfootanteriorposteriortranslation)dominatedthestudies,andgroundreactionforceswerestudiedmorefrequentlythanjointkinematicsandkinetics.Thisisbecauseofthefactthathumanlocomotionentailsmovementprimarilyinthesagittalplane,andtheinstrumentationusedtomeasuregroundreactionforcewasrelativelycommoninthelaboratorieswheretheresearchwasconducted.Therewerefewerstudiesthatexaminedtheeffectsofperturbationsinthefrontalplane,andonlyalimitednumberthatexaminedeffectsinthetransverseplane.Aresearchdesignclassifiedas"controlledbeforeafter"representedmorethan91%ofthestudies.Therewerenorandomizedclinicaltrials.Fiftysixpercentofthestudieswerebasedonfiveorfewersubjects,andthelargestnumberofsubjectsinanystudywas18.Controlledbeforeafterdesignsandarelativelysmallnumbersofsubjectsaretypicalofresearchinorthoticsandprosthetics.Thecostsofconductinggaitstudies,thechallengesofobtainingmeasurementsinvolvingmotioncaptureorEMGdata,therelativescarcityofamputeesubjects,andthedifficultyofcontrollingforthepotentiallylargenumberofconfoundingvariablesalmostnecessitatesstudiesbasedonrelativelysmallnumbersofsubjects.

    EVIDENCESTATEMENTSThelargenumberof"insufficientevidence"judgmentsresultedfromseveralfactors.First,internalandexternalvalidityissueswerecommon,withafailuretoconducttestsofstatisticalsignificancebeingdominant.Smallsamplepopulationswereasecondmajorreason.Athirdreasonwasthediversityoftheperturbationvariablesexaminedandoutcomesmeasuresused.Fewresearchersduplicatedthedesignsofotherstudies,andmanycellsoftheclassificationmatrixhadonlyalimitednumberofstudiesonwhichevidencestatementscouldbebased.

    Nearlyallthestudiesbeganwithanacceptablealignment,usedexperiencedamputees,andstudiedtheeffectsofperturbationsawayfromanacceptablealignment.Forthesereasons,alltheevidencestatementsareprefacedwiththewording"Amongexperiencedunilateraltranstibialamputeeswalkingforshortperiodsoftimeonalevelsurfaceinacontrolledenvironment(e.g.,gaitlaborclinic)duringexperimentsinwhich(someaspectofprosthesisalignmentisbeingperturbed)...."Thiscautionsthereaderthattheevidencestatementscannotbeassumedtoapplytonewamputeesortononlaboratoryconditions.Noneofthestudiesrequiredindividualstogainexperiencewithorattempttoadapttotheperturbationsoverdaysorweeks,soitisnotknownifthevaluesofsomeoftheoutcomemeasuresmayhavebeendifferentifthemisalignedprostheseshadbeenusedforlongertimeperiods.

    Statementscanbemadeatamoderatelevelofconfidencethatwithanacceptablealignmentanumberofsignificantkinematicandkineticdifferencesexistbetweentheprostheticlimbandthecontralaterallimbduringgait.Thesevariablesincludethemagnitudeoftheverticalpeakgroundreactionforcepeakkneeflexionanglesandtimingandkneeextensionmoment,impulseandwork(ES1,3,4).Groundreactionforceimpulseseemstoexhibitnosignificantdifferencebetweenlimbs(ES2).Significantdifferencesalsoseemtooccurduringgaitinitiationwithanacceptablealignmentbutdependonwhichlimbisinitiatingswingandwhichisinstanceinitially(ES812).

    Astatementjudgedtohaveahighlevelofconfidencebecauseevidenceseemedconsistentacrossnumerousstudies,wasthatwalkingspeedexhibitednosignificantchangewithperturbationofsocketangularalignment,footlinearposition,orfootinternalexternalrotationwhensubjectswereallowedtowalkataselfselectedcomfortablespeed(ES5).Arelatedstatementjudgedtohaveamoderatelevelofconfidencewasthatcadenceexhibitednosignificantchangewithperturbationofsocketangular

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    alignment,footlinearposition,orfootinternalexternalrotation(ES6).Evidencealsowasfoundatamoderatelevelofconfidencetosupportthehypothesisthatperturbationsproducenosignificantchangesinthesymmetriesofgroundreactionforcepeaks(ES7).

    Thesefindingsmayreflectthelaboratoryprotocolsandtheuseofexperiencedamputees.Oneofthearticles,whichwasbasedonclinicalobservationsandwasnotusedinthedevelopmentofthesestatementsbecauseofalackofmeasurementsandstatisticaltests,reportedthatwalkingspeedandcadenceseemedlowerwithanunacceptablealignment,andstepsweretakenwithmorehesitance(ER9).Theauthor'sownclinicalobservationssupportthis.Furtherresearchisneededtoverifywhetherdisparitiesexistbetweenmeasuresofwalkingspeed,cadence,andpeakgroundreactionforcesobtainedusingthelaboratorysettingsandprotocolsandthesamemeasurementsobtainedinclinicalsettings.Inclinicalpractice,thepractitionerusuallybeginswithabenchorstaticalignmentthatoftenisunacceptableandproceedstoworktowardanalignmentthatisacceptabletotheamputee.Theresearchissuesmightbe1)whethertheamputeeperceivesandrespondstotheeffectsofaspecificalignmentthesamewayirrespectiveoftheacceptabilityoftheinitialalignmentand2)whethertherearepsychologicalandmotivationalfactorsrelatedtogaitthatleadtodifferentoutcomesbetweenclinicalandlaboratorysettings.

    Thesecondstatementjudgedtohaveahighlevelofconfidencewasthatarangeofsocketflexionextensionangularalignmentsinthesagittalplaneincombinationwitharangeoffootanteriorposteriortranslationsseemtoresultinacceptablealignments(ES13).Therangewillvaryfrompatienttopatient(ES15).Researchconductedontherollovershapeofprostheticfeetsupportedthisfindingandofferedapossibleexplanation:alignmentattemptstomatchtherollovershapeoftheprostheticfootwiththatoftheanatomicfoot,andacceptablealignmentscanbeachievedalonganarchavingequivalentrollovergeometries(ES14).Evidencealsosupportedastatementatthemoderatelevelofconfidencethattherangeofacceptablealignmentsdecreasesifthewalkingsurfaceisinclined(ES16).Intrasocketpeakpressuresseemtorespondtosocketflexionextensioninthemannerforecastbyalignmentparadigms(ES17).3

    Withrespecttofrontalplanesocketabductionadduction,itcanbestatedatamoderatelevelofconfidencethatarangeofalignmentsincombinationwitharangeofmediallateralfoottranslationsareacceptabletotheamputee(ES18),andtherangevariesfromindividualtoindividual(ES19).Atthesamelevelofconfidence,itcanbeassertedthatpeakverticalgroundreactionforcesontheprostheticlimbshownosignificanteffectsfromalignmentperturbation(ES20).

    Regardingtheeffectsofprostheticfootplantarflexionanddorsiflexion,thenumberofstudiesfoundwasinsufficienttosupportstatementshavingmoderateorhigherlevelsofconfidence.Onestudyexaminedtheeffectsofheelandforefootwedgingusingarelativelylargesampleandobtainedintrasocketpressureresultsconsistentwithbiomechanicalparadigmsforalignmenttosupportonestatementatamoderatelevelofconfidence(ES21).Dataonsignalpowereffectsontheresiduallimbsupportedstatementsatamoderatelevelofconfidencethatheelwedgingincreasestheenergyabsorbedbythedistaltibiaanddecreasestheenergyabsorbedbythesubpatellarregionandviceversa(ES23,24).

    StatementsconcerninganteriorposteriortranslationofthefootcanbeincludedunderES13discussedpreviously.Therangeofacceptabletranslationsvariesfromindividualtoindividual(ES25).Atamoderatelevelofconfidence,itcanbeclaimedthatpressureonthedistaltibiaincreasesasthefootistranslatedposterioranddecreasesasthefootistranslatedanterior,whichisconsistentwithalignmentparadigms(ES26).Similarstatementscanbemadeatamoderatelevelofconfidencewithrespecttomediallateraltranslationoftheprostheticfoot(ES2729).

    Evidencedevelopedthroughstudiesoftheeffectsofinternalandexternalrotationofthefootsupport,at

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    themoderatelevelofconfidence,claimsthattherangeofacceptablealignmentsvariesfromindividualtoindividual(ES30),andthatinternalrotationof6seemstoproducesignificanteffectsontheprostheticlimbwithrespecttosinglelimbsupporttime(ES31)andkneejointpeakkneeflexionangle(ES32),whereas6ofexternalrotationdoesnot.Sixdegreesofinternalrotationalsoproducessignificanteffectsonthecontralaterallimbwithrespecttopeakkneejointextensionmoment,impulse,andwork,whereas6ofexternalrotationdoesnot(ES36).ClaimsofnosignificanteffectonpeakgroundreactionforcesfortheprostheticlimbcanbemadeataModerateLevelofConfidenceforupto6ofinternalrotationand36ofexternalrotation(ES33).Claimsofnosignificanteffectsatthesamelevelofconfidencecanbemadeforkneejointmomentsontheprostheticlimbforupto15ofinternalandexternalrotation(ES34).Forkneejointimpulseandwork,nosignificanteffectshavebeenclaimedforupto6ofinternalandexternalrotation.Thus,theavailableevidencesuggeststhatamputeesmaybemoresensitivetointernalfootrotationthantoequalamountsofexternalfootrotation.Theevidencealsosuggestsatentativehypothesisthattheeffectsofinternalrotationmayappearmorestronglyaskneerelatedkinematicvariablesontheprostheticsideandkneerelatedkineticvariablesonthecontralateralside.

    Asmallnumberofstudiesvariedpylonlength,butonlyonereportedfindingsthatfacilitatedthedevelopmentofEvidenceStatements.Thisstudyexaminedtheeffectsofpylonlengthinthecontextofgaitinitiation.Itfoundnosignificantchangesingroundreactionforcepeakmagnitudesandtiming,andprostheticfootcenterofpressurepatternsforaheightvariationof2cm(ES3739).

    INTERNALVALIDITYCONCERNSOnethreattotherepeatabilityofnearlyallthestudiesreviewedwasthefailureoftheresearcherstomeasurethesubjectiveacceptabilitytotheamputeesoftheinitialalignmentsandsubsequentalignmentsresultingfromperturbations.Giventhatarangeofalignmentsseemstobeacceptable,iftwodifferentprosthetistssettheinitialacceptablealignmentatoppositeendsoftherangeofacceptablealignmentsforanamputee,thentheoutcomesforidenticalperturbationscouldbedifferent.Withoutincorporatingsomeconsistencyanduniformityintothetaskofaskingsubjectstojudgetheacceptabilityofanalignment,andunlessthetaskisdescribedinthepublicationsthatresult,anexperimentinvolvingalignmentperturbationcannotbereproducedaccurately.Researchshouldbeconductedtodevelopaconsistentmethodofmeasuringsubjectiveacceptabilityandtodeterminehowrapidlyitchangeswithalignmentperturbation.

    Asecondpervasiveshortcomingofnearlyeverystudywasthelackofmeasurementoftheinitialacceptablealignmentfromwhichperturbationswereundertaken.Althoughthestudiesdescribedalignmentperturbationsquantitatively,theynearlyalwayslackedaquantitativedescriptionoftheinitialalignment,whichmakesitimpossibletoreproducethemaccurately.Thesestudiesreportedtheeffectsofperturbations,whichwererelativetoastartingpointthatlackedquantification.Oneofthemajorreasonsforthisisthelackofinstrumentationwhichcanbeusedtomeasuretherelativealignmentofthefootwithrespecttothesocket.Inexpensivebutaccurateinstrumentationthatcanbeusedtoquicklymeasureprosthesisalignmentbymeansofastandardizedreferencesystemisneededforresearchonalignment.Thiswouldbeusefulnotonlyforscientificresearchstudiesbutalsofordocumentinginterventionsandprovidingdataformedicalrecordsintheclinic.Bermeetal.4hasdescribedaconceptual3axissystemformeasuringsocketorientationSandersetal.5describedadevicetomeasuresocketangularorientationwhenaBerkeleyAdjustableLegisusedforalignmentSinetal.6describedanalignmentjigforquantificationoftranstibialprosthesisalignmentandKerretal.7designedadevicetomeasuresocketorientationwithrespecttothefoot.However,noinexpensivecommercialsystemsarecurrentlyavailableforclinicaluse.

    Samplesizesinthestudieswereoftensmall,possiblyduetothecomplexityandcostofundertakingoutcomemeasurementsrelatedtothemuscleactivity,kinematic,andkineticeffects,andpossiblyalso

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    becauseofthelimitednumberofamputeesubjectsavailableforresearchstudies.Asthenumberofsubjectsgrows,thepowerofthestatisticaltestsalsogrows,andthestrongerandmoregeneralaretheconclusionsthatcanbedrawnfromtheresults.Thedemonstrationofgeneralcauseandeffectrelationshipsconcerningalignmentperturbationisdifficulttoestablishwithonlyonesubject.Withonlytwoorthreesubjects,datamayshoweachsubjecttobeauniquecase.Thiswasavalidityconcernaffectingsomeofthestudiesonintrasocketpressures.

    EXTERNALVALIDITYCONCERNSManyofthestudiesseemedtobedesignedtostudygaitratherthantoanswerclinicalquestionsconcerningthecharacteristicsofanacceptablealignment.Onlyasmallnumberofstudiesactuallybeganwithbenchalignmentsandendedwithacceptabledynamicalignments,andonlyaverysmallnumberofstudiespresentedconclusionsthatwereusefulforalignment.Asaresult,fewofthestudiesproducedfindings,whichcouldbeapplieddirectlyintheclinic.

    Clinicallyrelevantresearchshouldalsoexaminetherelationshipbetweenthesubjectiveacceptabilityofanalignmentandgaitofvaryingduration,whichmaybetterreflectrealworldconditions.Kluteetal.8measuredthecontinuousgaitdurationsof12transtibialamputeesduringdailyliving,andfoundtheyperformnumerousactivitiesthathavegaitspansof1to2minutesatcadencesoflessthan17stepsperminute,andtheyperformfewactivitiesinvolvinggaitspansofmorethan15minutes.Thenumberofstepsperminuteseemedtopeakatapproximately70andwasassociatedwithactivitieshaving10minutegaitspans.Whengaitspanincreasedbeyond10minutes,thenumberofstepsperminutedecreased.Theauthorsconcludedthatalignmentshouldbe"optimized"for1to2minuteboutsofactivityatcadencesoffewerthan17stepsperminute.

    Definitionsforperturbationslackedconsistencyacrossthestudiesandrarelymatchedthoseusedbyclinicians.Tointerpretthestudiescorrectlyrequiredtransformationofthedataintoaclinicalframeofreference,whichwasbothdifficultandtimeconsuming.Aneffortshouldbemadetostandardizealignmentterminologyanddisseminatethedefinitionstoresearchers.

    ManyofthestudiesusedSACHfeetandPTBsocketsfeaturingPeliteliners.SACHfeethavemechanicalcharacteristicsthatareunlikethoseofenergystorageandreturnfeet,whichmaylimitsomefindingsjusttoSACHfeet.SACHfeethaveaneffectivefootlengthratio(theproportionoftheprostheticfootlengthactuallyusedduringastep)thatisshortincomparisontoenergystorageandreturnfeetandanatomicfeet.9Theeffectivefootlengthratiodeterminesthelengthoftherollovershapeofthefoot,whichinturninfluencesgait,andlikelyexertsaninfluenceonalignment.Arelevantresearchquestioniswhethertherangeofacceptablealignmentsvariesbytypeoffoot.AlthoughPelitelinersarestillinuse,manygellinersarenowbeingprescribedbecauseoftheirabilitytoabsorbandspreadintrasocketpressureconcentrationsoveragreaterarea,therebydecreasingdiscomfortandreducingthepotentialfortissuetrauma.Althoughthereisnoevidencedirectlyindicatingthatpressureconcentrationsinfluencegait,theexistenceofarelationshipbetweenintrasocketpressureandtheacceptabilityofalignmentiswellknownamongpractitioners.Itisnotknownifgellinersincreasetherangeofacceptablealignmentsforamputees.

    Allofthestudiesusedsubjectswhohadatleast1yearofexperienceasatranstibialamputee.Individualswiththismuchexperiencemayhavelearnedtocompensateforvariationsinalignment.Fromaclinicalperspective,itisthenewamputeeforwhomalignmentismostcritical.Newamputeesandexperiencedamputeeswhoarebeingfittedwithnewcomponentsmaytakeseveralweeksandseveralvisitstoachieveanacceptablealignment.Forthenewamputee,thiscouldbeacriticalperiodoftime,andthequalityofthealignmentcouldinfluencesubsequentrehabilitationprogress.However,noneofthestudiesexaminednewamputees.

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    OPTIMALALIGNMENTAsawhole,thereisinsufficientevidencetomakestatementsabouttheexistenceofmeasurablevariablesthatdefineanoptimalalignment.Optimizationimpliestheminimizationormaximizationofsomevariableorobjectivefunction.EvidenceStatementswithhighormoderatelevelsofconfidenceindicatethatgroundreactionforcepeaksandtiming,walkingspeed,andcadencewillnotrevealmisalignment.However,nineofthearticlesobtainedresultswhichsuggestedthatmeasurableindicatorsofoptimalalignmentmayexisteventhoughtheevidencepresentlyisinsufficient(ER2,57,14,17,24,25,30).

    Asmallamountofevidencepointstowardjointkineticsandkinematicsaspossibleindicatorsofmisalignment.Beyaertetal.,op.cit.(ER2),focusedontheroleofthecontralateralkneeasamechanismforprotectingtheprostheticlimbthroughshockabsorptionatthebeginningofstanceanddevelopedevidencethatanuncomfortablemisalignmentbecauseofinternalrotationofthefootproducedmaximalcontralateralkneeflexionandwork.Mizrahietal.,op.cit.(ER14),andSeliktaretal.,op.cit.(ER25),examinedoscillationsinthetransitionofanteriorposteriorgroundreactionforcefrombrakingtopropulsiveasapotentialindicatorofinstabilityatthekneeontheprostheticlimb.Theyproposedthatanoptimumalignmentwouldcorrelatetoaminimizationoftheseoscillations.Nofurtherresearchonthisconceptwasfoundintheliterature.Reedetal.,op.cit.(ER17),describedpreliminaryattemptstousepatternrecognitionandsignalprocessingmethodstoidentifymisalignmentbasedonanumberofkineticandkinematicvariables.Theyproposedthat"gaitdistortion"(thetermwasnotdefined)increasedmonotonicallywithmisalignment,whichimpliesthataminimumof"distortion"wouldexistatanoptimalalignment.Preliminaryresultsobtainedusingdiscriminantanalysisseemedpromising.Nofurtherresearchonthisconceptwasfound.

    WinarskiandPearson,op.cit.(ER30),foundtotalbodyjointworktobeminimizedforacceptablealignment.Ifthisisthecase,furtherresearchonmuscleactivity(EMG)andoxygenuptakewouldprovideadditionalevidence.Schmalzetal.,op.cit.(ER24),foundoxygenconsumptiontoincreasesignificantlywithfootplantaranddorsiflexionandanteriorposteriordisplacement.Fangetal.,op.cit.(ER7),simulatedmuscleactivityandestimatedthatjointexternalmomentswouldbeincreasedwithsocketflexionextensionfromacceptablealignment.Burnfieldetal.,op.cit.(ER5),alsofoundrelationshipsbetweenmisalignmentandmuscleactivity.Incontrast,Chowetal.,op.cit.(ER6),foundthatsteplength,stanceduration,verticalgroundreactionforce,andtimetomaximumkneeflexionexhibitedthehighestsymmetrybetweentheprostheticlimbandcontralaterallimbacrossarangeofacceptablealignmentsbutraisedthepossibilitythattheabilityofthemusculoskeletalsystemtoadapttochangesinprosthesisalignmentmaymeanthatarangeofalignmentsareequallyoptimal.Despiteallofthesefindings,thecurrentamountandqualityofevidenceisinsufficienttoplacemoderateorhighlevelsofconfidenceingeneralizedstatements.

    STUDYLIMITATIONSThearticleswerereviewedandevaluatedbyonlyoneindividualratherthanseveralindividuals.ThesameindividualdevelopedtheEvidenceStatementsandassignedconfidencelevels.Anelementofsubjectivitywasnecessary,althoughtheguidelinespreparedbytheAcademywithrespecttoassessmentofvalidityminimizethis.Somestudieslackedaccurate,cleardescriptionsoftheperturbationsbeingexamined.Althoughaneffortwasmadetocorrectlyinterpretthenatureoftheperturbationsandtranslateresultsintoaconsistentsystemofclinicaldefinitions,errorsmaypossiblyhaveoccurred.Contradictionsbetweentables,graphs,andstatementsinsomearticlesposedanotherthreat.Thepowerofthestatisticalsignificancetestsusedinthestudieswasnotdetermined.Becauseofthesmallsamplesizes,itislikelythatsomeofthetestslackedahighpower.

    CONCLUSIONS

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    TheguidelinesthathavebeendevelopedbytheAcademyareusefulforevaluatingthequalityofthescientificevidenceavailabletoassistclinicaldecisionmaking.Byusingtheguidelines,thisstudyhopefullyhascontributedtothedesignoffuturestudiesonthealignmentoftranstibialprostheses.Alignmentresearchdoesnotattractfundingtotheextentthatcomponentresearchdoes,becausealignmentisconsideredtobeanonreimbursableservicethatprosthetistsroutinelyperform,unlikecomponentsthatprosthetistscanbillinsuranceprogramsfor.

    Prosthetistshavebeenabletoproduceacceptablealignmentsforyearswithminimalscientificknowledge,or"evidence,"anditisreasonabletoaskwhatcanbegainedfromfurtherresearchonalignment.Severalbenefitscanbeidentified.First,thesophisticatedandcomplexanklecomponentscomingonthemarketmayrequirehigherstandardsofalignmenttoachievetheirbiomechanicalpotential.Second,manufacturersofsuchcomponentsneedtodevelopdesignswhosealignmentrequirementsmatchthecapabilitiesofclinicians.Third,cliniciansneedtobeabletodetect,diagnose,understand,andcorrectgaitproblemscausedbyalignment.Alignmentisoneofthemajordeterminantsofdiscomfortfortheamputee.Giventheimportanceofachievingcosteffectivenessinrehabilitationprograms,itisimportanttominimizediscomfortandenergyexpendituretotheextentpossible,sothatthemosteffectiveuseofexpensiveprostheticcomponentscanbeachieved.Becauseofwhatappearstobeanincreasingrateofgrowthinthenumberofresearcharticlesonalignment,togetherwiththeimportanceofalignmenttosuccessfuloutcomesintheclinic,itisrecommendedthatsystematicreviewsoftheresearchtranstibialalignmentbeundertakenatregularintervals.

    Disclosure:Theauthorsdeclarenoconflictofinterest.

    Correspondenceto:EdwardS.Neumann,PhD,PE,CP,FAAOP,CenterforDisabilityandAppliedBiomechanics,UniversityofNevada,Box4015,4505SMarylandParkway,LasVegas,NV891544015email:[email protected]

    REFERENCES

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    6. ChowDHK,HolmesAD,LeeCKL,SinSW.Theeffectofprosthesisalignmentonthesymmetryofgaitinsubjectswithunilateraltranstibialamputation.ProsthetOrthotInt200630:114128.

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    8. FridmanA,OnaI,IsakovE.Theinfluenceofprostheticfootalignmentontranstibialamputeegait.ProsthetOrthotInt200327:1722.

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    16. PinzurMS,CoxW,KaiserJ,etal.Theeffectofprostheticalignmentonrelativelimbloadinginpersonswithtranstibialamputation:apreliminaryreport.JRehabResDev199532:373378.

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    18. ReisingerKD,CasanovaH,WuY,MoorerC.Comparisonofapriorialignmenttechniquesfortranstibialprosthesesinthedevelopingworldapilotstudy.DisabRehabil200729:863872.

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    23. SandersJE,DalyCH.Interfacepressuresandshearstresses:sagittalplaneangularalignment

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    effectsinthreetranstibialamputeecasestudies.ProsthetOrthotInt199923:2129.

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    ADDITIONALREFERENCESCITEDINTHETEXT

    1. AmericanAcademyofOrthotistsandProsthetists.StateoftheScienceEvidenceReportGuidelines.Availableat:www.oandp.org/grants/MasterAgenda/AAOP_EvidenceReportGuidlines.pdf.

    2. AmericanAcademyofOrthotistsandProsthetists.TheBiomechanicsofGaitafterPartialFootAmputation.Proceedings,StateoftheScienceConference8.Chicago,IL,March34,2007.

    3. KappSL.Visualanalysisofprostheticgait.In:SmithD,MichaelJW,BowkerJH,eds.AtlasofAmputationsandLimbDeficiencies.3rded.Rosemont,IL:AmericanAcademyofOrthopedicSurgeons2004:385394.

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    4. BermeN,PurdeyCR,SolomonidisSE.Measurementofprostheticalignment.ProsthetOrthotInt19872:7375.

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    8. KluteGK,BergeJS,OrendurffMS,WilliamsRM,CzernieckiJM.Prostheticinterventioneffectsonactivityoflowerextremityamputees.ArchPhysMedRehabil200687:717722.

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    EDWARDS.NEUMANN,PhD,PE,CP,FAAOP,isaffiliatedwiththeCenterforDisabilityandAppliedBiomechanics,UniversityofNevada,LasVegas,Nevada.


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