Effects of Oculomotor and Gaze Stability Exercises on Balance after Stroke: Clinical Trial Protocol

Porto

Biomedical

Journal

Original

article

Effects

of

oculomotor

and

gaze

stability

exercises

on

balance

after

stroke:

Clinical

trial

protocol

Carla

Pimenta

_,

_Anabela

_Correia

_,

_Marta

_Alves

_,

_Daniel

_Virella

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received13October2016 Accepted9January2017 Availableonline12February2017 Keywords:

Stroke Balance

Domiciliarytraining Rehabilitation

Oculomotorandgazestabilityexercises

a

b

s

t

r

a

c

t

Background:Theinabilitytomaintainbalanceafterstrokeisanimportantriskfactorforfallingandrelates todecreasedpotentialforrecovery.Thevestibularsystemandgazestabilitycontributerespectivelyto posturalstabilityandtomaintainbalance.Rehabilitationmaybemoreeffectivewithdomiciliarytraining. Objective:Thistrialaimstoverifyifbalanceimpairmentafterstrokeimproveswithadomiciliary oculo-motorandgazestabilitytrainingprogram.

Methods: Individualsolderthan60years,dischargedaftersufferingbrainstrokewithreferraltothe physiotherapydepartment,willbeassessedfororthostaticbalance.Patientswithstrokediagnosis3–15 monthsbeforerecruitment,positiveRombergtestandabletowalk3maloneareinvitedtoparticipatein thisrandomizedcontrolledtrial.Participantswillbeallocatedintwointerventiongroupsthroughblock randomization,eitherthecurrentrehabilitationprogramortoasupplementalinterventionfocusedon oculomotorandgazestabilityexercisestobeappliedathometwiceadayforthreeweeks.Primary outcomemeasuresaretheMotorAssessmentScale,BergBalanceScaleandTimedUpandGoTest.Trial registration:ClinicalTrials.gov(NCT02280980).

Results:AminimumdifferenceoffoursecondsintheTUGandaminimumdifferenceoffourpointsin BBSwillbeconsideredpositiveoutcomes.

Conclusions:Oculomotorandgazestabilityexercisesmaybeapromisingcomplementtoconventional physiotherapyinterventionafterbrainstroke,improvingthebalanceimpairment.

©2017PBJ-Associac¸˜aoPortoBiomedical/PortoBiomedicalSociety.PublishedbyElsevierEspa ˜na, S.L.U.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/ licenses/by-nc-nd/4.0/).

Introduction

Strokeisoneofthemajorcausesoflong-termdisabilityinthe adult;balancedeficitsoccurringafterstrokearestrongly associ-atedwithmoreseverelyimpairedmotorfunctionandadecrease inrecoverypotential.1,2

Inpatientswho have had strokeswithinabilitytomaintain balance,eitherinastaticorinadynamicway,itcouldbe asso-ciatedwiththeimpairmenttoselectreliablesensoryinformation fromdifferentsources(visual,vestibularandsomatosensory sys-tems)inordertomaintainposturalstabilityusingacorrectmotor pattern.3,4_{Bothposturalimbalancesafterstrokeandgaitdisorders}

Abbreviations: VSR,vestibulo-spinalreflex;VOR,vestibulo-ocularreflex;BBS, BergBalanceScale;TUG,TimedUpandGoTest;RCT,randomizedcontrolledtrial; MAS,MotorAssessmentScale.

∗ Correspondingauthor.

E-mailaddress:carla.vicente.pimenta@gmail.com(C.Pimenta).

areimportantriskfactorsforfalls.5_{Thehighincidenceoffallsin}

thesepatientsiswelldocumentedintheliterature,aswellasits socialandeconomicimpact.6

Thevestibularsystemcontributestoposturalstabilityandvisual stabilization through the vestibulo-spinal reflex (VSR) and the vestibulo-ocularreflex(VOR),respectively.7

VORisthefirstmechanismofgazestability.Duringhead move-ments,theVORstabilizesgaze(eyepositioninspace),generating eyemovementsofequalspeedandoppositedirectiontothe move-mentofthehead8_{toallowanadequatevisualacuity,}9_whiletheVSR

contributestomaintainposturalstabilityactivatingcontractionof theantigravitymuscles.7

Gazestabilityisneededtocoordinatethemovementsofthe head,trunkandpelvisduringwalking.10_{Individualsafterstroke}

have been described to exhibit abnormal coordination of axial segmentsandpelvicrotationsduringheadrotation,whichcan con-tributetochangesinbalanceduringgait.11_{Thedecreaseinstability}

ofthetrunkandheadafterstrokealsocausesalackofqualityin visualinformation,whichmaycauseimpairedbalance.11

http://dx.doi.org/10.1016/j.pbj.2017.01.003

2444-8664/©2017PBJ-Associac¸˜aoPortoBiomedical/PortoBiomedicalSociety.PublishedbyElsevierEspa ˜na,S.L.U.ThisisanopenaccessarticleundertheCCBY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Gazestabilityexerciseshavebeendescribedtoimprovepostural stabilityinhealthyyoungadults,12_{improvebalanceand}

subjec-tiveconfidencetocarryouttheactivitiesofdailylifeinahealthy elderlypopulation13 _{and to decreasethe perceptionof}

disabil-ityinindividualswithunilateralvestibulardeficit.14_Ithasbeen

suggested thatVOR adaptationexercises have influenceonthe alignment ofthehead,resulting onimprovementsin the over-allperceptionofbalance,expandingthelimitsofstability.15_The

improvementsachievedwiththeseexercisesindifferentclinical conditionswerenotassociatedwithgender,16_age16,17_andtimeof

onsetofsymptoms,17_{thereforeitmaybeassumedthattheycanbe}

usedbothinchronicconditionsandintheelderly.17

Oculomotorandgazestabilityexercisesareeasytolearn, there-fore,aftersupervisedtraining,theycanbeperformedathome,13

autonomously or with minimal supervision, as a complement toinstitution-basedrehabilitationprograms.Domiciliarytraining programsallowexercisingatleasttwiceaday,sevendaysaweek, givinggroundtoquicker,morecompleterecovery.

This trial aims to verify if balance impairment after stroke improveswithadomiciliaryoculomotorandgazestabilitytraining programforseniorpatients.

Methods

Design

Non-blinded,randomizedcontrolledtrial(RCT)(Fig.1). Patientpopulation

Individualsolderthan60years,dischargedaftersufferingbrain strokewithreferraltothephysiotherapydepartmentoutpatient clinicofatertiarycarehospital(CentroHospitalardeLisboa Cen-tral).

Outcomemeasures

Primaryoutcomemeasuresare:

1.ThevariationintheBergBalanceScale(BBS)scorefrombaseline aftersufferingabrainstrokeuptothreeweeksofintervention anditsassociationtothehome-basedprogramofoculomotor andgazestabilityexercises,and

2.ThevariationintheTimedUpandGoTest(TUG)frombaseline aftersufferingabrainstrokeuptothreeweeksofintervention anditsassociationtothehome-basedprogramofoculomotor andgazestabilityexercises.

Participants Recruitment

Individualsareeligibleforthetrialiftheyfulfillthefollowing inclusioncriteria:

-Brainstrokediagnosed3–15monthspriortorecruitment, -Verifiedpresenceofimpairedbalance(positiveRombergtest),

and

-Abilitytowalkatleast3malonewithorwithoutanassistive device.

Individualsarenoteligibleif:

-Thebalanceproblemsareprevioustothebrainstroke,

-Theabilitytoperformtheproposedexercisesiscompromisedby severeosteo-articulardisease,or

-Theyhadpreviousexperiencewithoculomotororgazestability exercises.

Randomization

Aftertheinitialassessment,participantswillbeallocatedintwo interventiongroupsthroughblockrandomizationwith stratifica-tionbyage,functionality andbalance.Threeagegroupswillbe considered:60–69years,70–79yearsand≥80years.Patientswill bestratifiedbytheirfunctionalityintothreecategories,according tothescoreoftheMotorAssessmentScale(MAS):major depend-ence(scorebelow16),moderatedependence(scorebetween17 and32)andminordependence(scoreover33),andbytheir bal-anceintotwocategories,accordingtothepredictivecut-offpoints forfallingusingTUG18_andBBS19_{:noriskoffalling(TUG<14sand}

BBS>45)orwithriskoffalling(TUG>14and/orBBS<45).

Samplesize

Thesamplesizewasestimatedconsideringtheabilitytoidentify (power90%andconfidence90%)eitheraminimumincreaseoffour pointsinBBS20_{orminimumdecreaseoffoursecondsinTUG.}20,21

The estimatedminimum sample size todetect foursecondsof differenceintheTUGinindividualswiththetargetpopulation char-acteristicsis18elements.Theestimatedminimumsamplesizeto detectadifferenceof4pointsinBBSinindividualswiththe tar-getpopulationcharacteristicsis66elements,thusthiswillbethe estimatedtargetsamplesize.

Studyprocedures

Aftercheckingforeligibilitycriteria,thepatientswillbeinvited toparticipateandinformed,writtenconsentwillbeobtained.

ParticipantswillhaveabaselineassessmentwithMAS(toaccess thelevelofdependence),BBSandTUG(toaccessbalance). Fur-thermore,demographicandclinicinformationwillbecollectedby interviewandconfirmedbyconsultingthepreviousclinicalrecords (whenavailable),includingthedateofthestroke,location, later-alityandetiology,andparticipantswillbeaskedaboutprevious balanceproblems,treatmentswithoculomotororgazestability exercises,severeosteo-articularproblems,gaitability,numberof fallsafterstroke,andpresenttherapies.

Therehabilitationprogramforstrokepatients,inthisunit,is customizedaccordingtothepatientproblemsandbasedonthe professional’s clinicalreasoning supportedin the knowledgeof neurophysiology,motorcontrol,biomechanicsandmotorlearning theories,22_{usingamixtureofcomponentsfromseveraldifferent}

approaches.23

Participantswillberandomlyassignedtoeithertheusual reha-bilitation programonly ortotheprogramwitha supplemental intervention,tobeappliedathomeforthreeweeks,asusedinthe studyofMorimotoandcolleagues.12

Participants in the supplemental intervention group will be taughtasetonoculomotorandgazestabilityexercises(Table1) andwillreceivealeafletandalogbook.Whentheparticipantshave difficultiesinlearningorperformingtheexercisesbythemselves, acaregiverwillberequiredtocollaborate.

Thesupplementalexerciseswillbereviewedeveryweekwith theparticipantstocheckthecompliancewiththehomeprogram,to clarifydoubtsandtoregisterdifficultiesorpossibleadverseeffects. After three weeks, every participant will be submittedto a balanceassessment(BBSand TUG)andwillbeaskedaboutthe numberoffallsthatoccurred.Theparticipantsinthe supplemen-talinterventiongroupwillbeaskedtoreturnthelogbooktothe investigators.

Brain stroke patients, older than 60 years,with balance deficits, admitted for physiotherapy as

outpatients

Consent obtained and baseline assessement to all

eligible patients

Experimental: The current rehabilitation program is supplemented with a intervention focused on oculomotor and gaze stability exercises to be applied at home twice a day

Block randomization with stratification by age, functionality and balance No intervention: The current rehabilitation program in the physiotherapy department for patients after stroke

Three weeks after Post intervention assessment

Outcome measures Demographic information Primary outcomes

Berg balance scale Timed up and go test Secondary outcomes

Rombergtest

Motor assessment scale Inclusion Criteria:

- Stroke diagnosis -3 and 15 months,

- Balance deficits -Patients able to walk 3 meters alone

Exclusion Criteria: -Previous balance problems,

- Severe osteo-articular changes,

- Have already done oculomotor or gaze stability exercises.

Fig.1.Flowchartoftheinterventionalrandomizedcontrolledtrial.

Alltheassessments,thetrainingfortheexercisesandtheir peri-odicalreviewareperformedbyoneofthetwophysiotherapists responsibleforthetrial.

Rombergtest–Itisastaticbalancetest,24_performedona

sta-blesurface,inwhichthepatientstandswiththeirfeettogether, firstwiththeeyesopenandthenwiththeeyesclosed;thetestis repeatedonanunstablesurface(balancepadwith60mmthick) underthesameconditions.Thetestistimed,consideringthetime untilthepatienteithermovesafootfromtheinitialposition,opens hiseyesorreachesthemaximumtimeof30s.Anyofthe condi-tionsbefore30swillbeconsideredlossofbalanceandapositive Rombergtest.25_{Compensatorymovementsoftheupperlimbsor}

trunkareaccepted.

BergBalanceScale(BBS)26,27_{–Itisaninstrumenttoevaluate}

bal-ancebyassessingtheperformanceon14functionaltasksinolder peoplewithimpairment.Thetotalscorerangesfrom0to56points. Ascorelowerthan45pointsisconsideredasriskoffalling.19_Ina

systematicreviewoftheassessmentofbalanceitwasfoundthat moststudiesusedtheBBSandfoundstrongevidencethatthisscale issensitivetobalancedisordersinacutestrokepatientsandinthe chronicphaseofstrokeinpatientswithlowinitialBBSscore.2

TimedUpandGoTest(TUG)–Itisasimpletestusedtoassess mobility andrequires both staticand dynamic balance.Several studiesuseTUGasanindicatorfortheriskoffalling.18,28_Avalue

greaterthan14sisconsideredpredictiveofriskoffallinginelderly community.18

MotorAssessmentScale(MAS)–Itisaperformance-basedscale developed to assess everyday motor function in patients with stroke.29_{Itconsistsof8itemscorrespondingtodifferentareasof}

motorfunction,eachitemisscoredfrom0to6,andthemaximum scorerepresentsoptimalperformance.

Dataanalysis

Datawillbeanalyzedusingdescriptivestatisticsandstatistical inference(univariableandbivariable),bothasforintentiontotreat andasperprotocol.Theparticipantswhoarenotabletolearnthe exercisesofthehomeprogram;thosewithlackofadherence(less than50%oftheproposedplan)andthosethatinterrupttheusual rehabilitationprogramformorethanoneweekforanyreasonwill beidentifiedandexcludedfromtheperprotocolanalysis.The mul-tivariableanalysiswilltakeintoaccountthetimelapsefromstroke tointerventionandtheoccurrenceofpreviousknownstrokes,as potentialconfounders.

Ethicalconsiderationsandregistration

Informed,writtenconsentwillbeobtainedfollowingscreening foreligibilitycriteria. TheprotocolwasapprovedbytheEthical CommitteeofCentroHospitalardeLisboaCentralandwas regis-teredatClinicalTrials.gov(NCT02280980).

Table1

Descriptionoftheoculomotorandgazestabilityexercises(basedonMorimotoand colleagues12_).

Thehomeprotocolconsistsineightdifferentoculomotorandgazestability

exercises

Exercise1 Movingtheeyeshorizontallybetweentwostationary

targetswhilekeepingtheheadstill–saccadiceye

movementexercises.

Exercise2 Movingtheeyesverticallybetweentwostationarytargets

whilekeepingtheheadstill–saccadiceyemovement

exercises.

Exercise3 Movingthetargethorizontallyandtrackingitwiththe

eyeswhilekeepingtheheadstill–smoothpursuit

exercises.

Exercise4 Movingthetargetverticallyandtrackingitwiththeeyes

whilekeepingtheheadstill–smoothpursuitexercises.

Exercise5 Movingtheheadhorizontallywhilekeepingthelookona

stationarytarget–adaptationexercises.

Exercise6 Movingtheheadverticallywhilekeepingthelookona

stationarytarget–adaptationexercises.

Exercise7 Movingtheheadandtargetinoppositedirections

horizontallywhiletrackingthetargetwiththeeyes–

adaptationexercises.

Exercise8 Movingtheheadandtargetinoppositedirections

verticallywhiletrackingthetargetwiththeeyes–

adaptationexercises.

Participantsshouldperformtheexercisesathome,standing,twiceadayfor

threeweeks.Eachexerciseshouldberepeated10times.

Participantsareinstructedtomovethetarget,ortheirhead,slowlywhile

maintainingclearfocusonthetargetduringtheexercises.

Iftheparticipantsfeelanykindofimbalanceordizzinesssensation,during

theexercises,theyshouldmakeasmallpauseandrestartwhenpossible.

Allexercisesareexplainedandmadewithparticipantstoensurethecorrect

performance.Ifnecessary,athirdpersonwillhelpthepatientforcorrectand

safeperformance.

Expectedresults

AminimumdifferenceoffoursecondsintheTUGanda min-imum differenceof4 pointsin BBSwillbe consideredpositive outcomes.

Fortheperprotocolanalysis,thedifferenceofbothBBSandTUG betweenbaselineandthefinalassessmentwillbecomparedusing pairedsamplestests.Riskratiosforpositiveoutcomeswith95% confidenceintervalswillbeestimated.Regressionmodelswillbe usedtoexplorefactorsthataffecttheoddsforsuccess.

Fortheintentiontotreatanalysiseverypatientwillbe con-sidered;thosethatdonotcomplyandthosethatdonotachieve

theminimumdifferencesconsideredforBBSorTUGaspositive

outcomeswillbeconsideredasfailures.Hazardratiosforpositive outcomeswith95%confidenceintervalswillbeestimated.Mixed modelsofstructuredequationswillbeusedforanalysisof longitu-dinaldatatoexplorefactorsthataffecttheoddsforsuccess.

Finalconsiderations

The effectivenessoculomotor and gaze stability exercises in improvingposturalstabilityandbalancehasbeenprovenbyseveral studiesinhealthyindividuals,12_{patientswithmultiplesclerosis}30

andwithvestibulardisorders.31–33_{Theseexercisesmayprovetobe}

apromisingapproachtobeincludedasacomplementinthe phys-iotherapyinterventionafterstroke,whenbalancedeficitispresent. Thistrialaimstoverifyifbalanceimpairmentafterstrokeimproves withadomiciliaryoculomotorandgazestabilitytrainingprogram forseniorpatients.Thetrialmaybeaffectedbysomeconfounders, suchasthetopographyofthestroke,associatednewandprevious impairments,differentrecoverypotentialandthecustomizationof thecurrentrehabilitationprogramtospecificpatientneeds.

Funding

Nonedeclared.

Authors’contributions

Allauthorsparticipatedindevelopingthedesignofthestudy and contributedtoand criticallyappraisedthemanuscript.The authorshavegivenfinalapprovaloftheversiontobepublished andtheyconfirmthattherearenootherpersonswhosatisfiedthe criteriaforauthorship.

Conflictofinterest

Theauthorsdeclarenoconflictsofinterest.

Acknowledgements

We acknowledge thestaff from theDepartment of Physical MedicineandRehabilitationatCurryCabralHospital(Centro Hos-pitalardeLisboaCentral).Noexternalfundingwasgrantedtothis institutionalclinicaltrial.

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