ERIC ED611838: START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants with Neuromotor Disorders: A Multisite Randomized Clinical Trial

2020·1 MB·English

by  ERIC

PTJ:PhysicalTherapy&RehabilitationJournal |PhysicalTherapy,2021;101:1–11
DOI:10.1093/ptj/pzaa232
AdvanceaccesspublicationdateDecember31,2020
OriginalResearch
START-Play Physical Therapy Intervention
Impacts Motor and Cognitive Outcomes in
Infants With Neuromotor Disorders:
A Multisite Randomized Clinical Trial D
o
w
n
Regina T.Harbourne, PhD,PT1,*,Stacey C.Dusing,PhD2,Michele A.Lobo,PhD,PT3, loa
d
e
Sarah W.McCoy,PhD4,Natalie A.Koziol,PhD5,Lin-Ya Hsu,PhD4,Sandra Willett,PT,PhD6, d
fro
Emily C.Marcinowski,PhD7,Iryna Babik, PhD8,Andrea B.Cunha,PhD3,Mihee An, PhD9, m
h
Hui-Ju Chang,PhD1,James A.Bovaird,PhD5,Susan M.Sheridan,PhD5 ttp
s
1DuquesneUniversity,Pittsburgh,Pennsylvania,USA ://a
c
2UniversityofSouthernCalifornia,LosAngeles,California,USA a
d
3UniversityofDelaware,Newark,Delaware,USA em
4UniversityofWashington,Seattle,Washington,USA ic
5UniversityofNebraska-Lincoln,Lincoln,Nebraska,USA .ou
p
6MunroeMeyerInstitute,UniversityofNEMedicalCenter,Omaha,Nebraska,USA .c
7LouisianaStateUniversity,BatonRouge,Louisiana,USA om
8BoiseStateUniversity,Boise,Idaho,USA /p
9KayaUniversity,Gimhae-si,Gyeongsangnam-do,RepublicofKorea tj/a
rtic
*AddressallcorrespondencetoDrHarbourneat:[email protected] le
/1
0
1
/2
Abstract /pz
a
a
Objective.OurobjectivewastoevaluatetheefficacyoftheSittingTogetherandReachingtoPlay(START-Play)intervention 2
3
inyounginfantswithneuromotordisorders. 2/6
0
Method.Thisrandomizedcontrolledtrialcomparedusualcareearlyintervention(UC-EI)withSTART-PlayplusUC-EI.Analyses 5
6
included 112 infants with motor delay (55 UC-EI, 57 START-Play) recruited at 7 to 16 months of age across 5 sites. START- 33
1
Play included twice-weekly home visits with the infant and caregiver for 12 weeks provided by physical therapists trained b
y
intheSTART-Playintervention;UC-EIwasnotdisrupted.OutcomemeasuresweretheBayleyScalesofInfantandToddler h
Development,ThirdEdition(Bayley);theGrossMotorFunctionMeasure;reachingfrequency;andtheAssessmentofProblem arb
SolvinginPlay(APSP).Comparisonsforthefullgroupaswellasseparatecomparisonsforinfantswithmildmotordelayand ou
infantswithsignificantmotordelaywereconducted.Piecewiselinearmixedmodelingestimatedshort-andlong-termeffects. rn
e
r@
Results. For infants with significant motor delay, positive effects of START-Play were observed at 3 months for Bayley
d
cognition,Bayleyfinemotor,andAPSPandat12monthsforBayleyfinemotorandreachingfrequencyoutcomes.Forinfants uq
withmildmotordelay,positiveeffectsofSTART-PlayfortheBayleyreceptivecommunicationoutcomewerefound.Forthe .ed
u
UC-EIgroup,theonlydifferencebetweengroupswasapositiveeffectfortheAPSPoutcome,observedat3months. o
n
Conclusion. START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with 2
7
significant motor delay over UC-EI in the short term. START-Play in addition to UC-EI may not improve motor/cognitive F
e
outcomesforinfantswithmildermotordelaysoverandaboveusualcare. b
ru
a
Impact.Conceptsofembodiedcognition,appliedtoearlyinterventionintheSTART-Playintervention,mayservetoadvance ry
cognitionandmotorskillsinyounginfantswithsignificantmotordelaysoverusualcareearlyintervention. 2
0
2
LaySummary.Ifyouhaveayounginfantwithsignificantdelaysinmotorskills,yourphysicaltherapistcanworkwithyou 1
to develop play opportunities to enhance your child’s problem solving, such as that used in the START-Play intervention, in
additiontousualcaretohelpyourchildadvancecognitiveandmotorskills.
Keywords:Infant,MotorDevelopment,EarlyIntervention,NeuromotorDelays,Reaching,Problem-Solving,EmbodiedCognition
Received:July27,2020. Accepted:November23,2020
©TheAuthor(s)2020.PublishedbyOxfordUniversityPressonbehalfoftheAmericanPhysicalTherapyAssociation
This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivs licence (http://
creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium,
providedtheoriginalworkisnotalteredortransformedinanyway,andthattheworkproperlycited.Forcommercialre-use,pleasecontact
[email protected]
2 PrimaryOutcomesoftheSTART-PlayTrial
Introduction
Early intervention for infants with developmental delays is
basedonthepremiseofearlyneuroplasticity.1 Theoretically,
building a strong framework for early brain pathways pro-
vides the architecture for future complex skills, both cogni-
tive and motor. The Sitting Together and Reaching to Play
(START-Play) clinical trial proposed a theory of change in
whichearlymotorskillsofsittingandreachinginteractwith Figure1.Theoryofchange:earlysittingandreachinginteractwith
and support the development of problem-solving skills to problemsolving,leadingtoadvancesinglobaldevelopment.
advance cognitive and global development (Fig.1).2,3 The
theory holds that for young infants with motor delays, the D
criticaltimingofachievingsittingandreachingwithinamilieu and reaching. Although most of the infants in the UC-EI ow
n
of environmental learning opportunities could change the groupreceivedonlynaturalenvironmentPartCservices,some lo
a
trajectoryofcognitiveadvancement.4,5 of them received only outpatient therapy,and some received d
e
theAIlnthdoivuigdhuamlsawnditahteDdisbaybillaitwyEindutchaetiUonniItmedprSotvaetemsetnhtrAoucgt,h6 rbeoctehivteydpewseorfesecrovnicsiedse(rTedabu.2n)d;etrhuths,eatlelrsmervoicfes“uthsueaclhicladrree.n” d from
early intervention (EI) and/or outpatient therapy services Ourfirstprimaryhypothesiswillbeaddressedinthispaper: h
(referred to,combined,asusualcare-earlyintervention [UC- ComparedwiththeUC-EIgroup,theSTART-PlayplusUC-EI ttps
EI] in this study) for infants with delays varies widely in groupwillshowgreaterimprovementsfrombeforetheinter- ://a
bothtypeandamount.7 Arecentsystematicreviewsupports ventiontoaftertheintervention(shortterm)andinthelong ca
d
that EI advances cognitive skills in infants born preterm.8 term(1-yearfollow-up)insitting,reaching,problemsolving, em
However, a systematic review of intervention for infants andglobaldevelopmentoutcomemeasures.Inaddressingthis ic.o
with movement disorders reveals both a lack of evidence firstprimaryhypothesis,weoptedtoexpandourinvestigation u
p
andheterogeneityofinterventionapproaches.9Thesereviews tobetterunderstandthevariabilitywithinthesamplebycom- .co
showalackofsupportforinterventionapproachesbasedon paring intervention efficacy between the intervention groups m/p
either a reflex/maturation model of development or practice across the entire sample as well as separately for infants tj/a
of motor skills as presented in motor learning theory. In withmildorsignificantmotordelayatbaselinetodetermine rtic
addition,previous studies measured motor skills in isolation whether the short-term rate of change in infant outcomes le
from and without regard to changes in cognition.9 Interven- differs on average (baseline through 3 months after inter- /10
1
tion approaches showing promise include the elements of vention) and whether the long-term rate of change in infant /2
promoting infant-initiated movement, engaging families in outcomesdiffersonaverage(baselinethrough12monthsafter /pz
a
brainstorming for intervention planning, and environmental intervention). a2
enrichment/adaptation to facilitate skill development.9,10,11 32
/6
An evidence gap exists regarding intervention effectiveness Methods 05
when the above key principles are embedded within early 63
therapies.8 For the purposes of this study, although natural Five clinical sites in different regions of the United States 31
environmentEIservicesaretheoreticallydifferentfromclinic- (Seattle,WA; Omaha,NE; Pittsburgh,PA; Newark,DE; and by
basedservicesinEI,allservicesbeingprovidedtotheinfants Richmond,VA)participatedinthisstudy,allowingforabroad ha
aspartoftheirusualcarewereincludedasUC-EI. inclusion of UC-EI models and demographic groups.Ethical rb
o
The START-Play intervention builds on existing evidence approval was obtained from the institutional review boards urn
blendingmovementactivity,suchastheprogressionofsitting at all sites. Families were recruited through social media, er@
and reaching, with specific cognitive constructs. Embracing mailings,andwebsitesaswellasthroughmedicalcentersand d
the embodied cognition concept, START-Play espouses that therapyproviders. uq
.e
the mind and body are inextricably linked.3,12 Thus,infants d
u
learnthroughperformingactionsandexperiencingtheircon- Participants o
n
sequencesinrelationtocognitiveconstructs.13InSTART-Play, Infants were enrolled based on sitting skill at study entry,so 2
7
the cognitive constructs of focus were means-end relations, all infants began intervention when they were beginning to F
e
object permanence, object affordances, and joint attention.3 sit.14 This stage of motor development was chosen because b
ru
Theprovisionoflearningopportunitiesrelatedtothesecon- sitting is critical for multiple motor and cognitive abilities: a
structswassystematicallyadvancedwithincrementalchanges objectexploration,15 visualmotorcoordination,16 andsocial ry 2
0
in motor ability to simultaneously advance action and cog- interaction with others.17 The inability to sit by 9 months 2
1
nition (Tab.1).3 The key ingredients of START-Play are: isacommonreasonforEIreferral,makingthisintervention
cognitiveconstructsembeddedwithinmotoractivities;motor relevanttotheinitiationoftherapyservices.18
and cognitive skills advanced together at the “just-right” Infantswererecruitedatcorrectedagesof7to16months
level;parentandtherapistbrainstormingregardingcognitive- onarollingbasisbetween2016and2019andfollowed-upfor
motorinteraction;movementflexibilityallowedwithoutrigid 1year.Initially,155potentialparticipantswererecruitedand
adherence to “normal patterns”; and all therapy provided assessed for eligibility. Inclusion criteria were a gross motor
within a social, engaging context guided by degrees of joint scoreof>1.0SDbelowthemeanonthegrossmotorsubtest
attention.3 oftheBayleyScalesofInfantandToddlerDevelopment,Third
This study compares infants with neuromotor disorders Edition (Bayley)19; a neuromotor disorder such as cerebral
receiving UC-EI with those receiving the START-Play inter- palsy;anincreasedriskforcerebralpalsyduetoprematurity
ventioninadditiontoUC-EIduringtheemergenceofsitting orbraindamagearoundbirth;amotordelayofanunknown
Harbourneetal 3
Table1. ComparisonofSTART-PlayInterventionContentWithUC-EIContent,ExemplifyingConstructsofSTART-Play,andNotableDifferencesa
ExampleContent UC-EI START-PlaySession Difference
Sittingandobject 1.Practicesittingbalancereactionson 1.Selectactivityformotor-based 1.Cognitiveconstructselectedfirst
permanence ball(isolatedmotortask) problemsolving:findinghiddentoy. andisprimary;movementsbuilt
2.Therapistprovidesseatedsupportto Infantencouragedtoshiftweight, aroundcognitiveconstruct
constraintrunkandsuggestspresenting re-orienttolookbehind/under/in 2.Parentstaughtthatchairispassive
toysontrayinfrontofinfantand containers,thusbuildingsittingbalance andnotvariable.Multipleseated
modelinguseoftoy inserviceofspatialunderstanding options,withminimalsupport
2.Dynamiclowsupportinsitting needed,allowexplorationandlink
allowsinfanttore-orientandgain motortoproblemsolving
spatialunderstanding;multipleoptions
D
forvariablesittingsupportdepending o
onproblem-solvingtask wn
Reachingand 3.Presentstoysindifferentlocations 3.Setsupenvironmentsoreachinga 3.Cognitiveconstructofmeans-end lo
a
means-end forinfanttoreach proximalobject(beads)willcause isover-archingthemeinmotor d
e
4co.lPorress,ewntesigthoty,saonfddtiefxfetruernetssfhoarpinesf,ant d4i.sPtalalcoebsjdecetsitroabmleovtoey(tjiuesdttoouottohferretaocyh) a4c.tIinvfiatinetsmustsolveaproblem;how d fro
m
toreach butonclothsoinfanthastopullcloth toreach“unreachable”toy. h
togettoy Cognitiveisendpointofmotor ttp
Reachingandobject 5.Usestoytohaveinfantreachina 5.Severalobjectspresentedthatallow p5.roInbflaemnt.discoverspropertiesand s://a
c
affordance patternthatrequireschangeoftrunk combinationsthatareinteresting,eg, usesforobjectsandwhatmotor a
d
posture smallballthatfitsinatubeandflies change(varioussittingandreaching em
outotherend,showingaffordanceof options)allowstheactiontooccur ic
objects(roundaffordsrolling,tube .o
u
affordsin/out) p.c
o
m
aSTART-Play=SittingTogetherandReachingtoPlay;UC-EI=usualcare-earlyintervention. /p
tj/a
origin; an ability to sit propped up on the arms for support SD below the mean at baseline.The latter 7 infants did not rticle
for at least 3 seconds; spontaneous movement of the arms; meet our original inclusion criteria and were thus excluded /1
0
1
andaninabilitytotransitioninandoutofsitting.Exclusion prior to analysis for final outcomes. A total of 112 infants /2
criteria were medical complications limiting participation in were included in the final analyses. Twenty-three (21%) of /p
z
a
assessments and intervention (eg, severe visual disorder); a those infants dropped out before the end of the study, with a
2
primarydiagnosisofautism,Downsyndrome,orspinalcord nonsignificant differential attrition (9.7%) between groups. 3
2
injury; a diagnosed uncontrolled seizure disorder; or a neu- Combined, these rates fall under the What Works Clearing- /6
0
rodegenerativedisorder. house23 classification of low attrition (“tolerable threat of 56
3
Atotalof134infantswererecruitedandparticipatedwith bias under optimistic assumptions”)23(p10). We believe opti- 3
1
written, informed parental consent (see Suppl. Appendix A: misticassumptionsarejustifiedhere,asthereasonfordrop- b
y
CONSORT flow chart). Participants maintained their base- pingoutwasunrelatedtotheinterventioninmanycases(eg, h
a
linetherapyservicesbecausewithholdingoralteringtherapy participants moved; catastrophic flooding prevented follow- rb
o
wasdeemedunethical.Blockedrandomizationwascompleted up).Differences in baseline infant and family characteristics u
rn
afterbaselineassessment,withstratificationinto3groupsof byattritiongrouparepresentedinSupplementaryAppendix e
r@
movement ability designed to achieve equivalent groups. A B. Completers were more likely to be White, not Hispanic,
d
scale incorporating estimated Gross Motor Function Classi- haveproblemsseeing,andhavehigherhouseholdincomeand uq
ficationSystemlevel,20 ManualAbilityClassificationSystem greater affordances in the home environment and were less .ed
level,21 distribution of motor impairment (eg, quadriplegia, likelytohavereceivedtherapyviaprivatepractice.Procedures u o
n
hemiplegia),andactivemovement(high,medium,low,judged for reducing bias due to missing data are discussed in the 2
byexperiencedtherapists)definedthesegroups.3 Thisstrati- statisticalanalysissection. 7 F
fication ensured that intervention groups were balanced on The data from the infants were analyzed together,as well eb
level of initial movement ability at baseline. Randomized, as grouped,by severity of motor delay measured at baseline rua
sealedenvelopeswithgroupassignmentswerecreatedbythe (minordelay:>1.0to<2.5SDsbelowthemeanfortheBayley ry 2
datasiteattheUniversityofNebraska,Lincolnforeachsite motorcompositescore;significantdelay:≥2.5SDsbelowthe 02
1
priortoenrollmentandopenedafterbaselineclassification. mean).Baselineparentquestionnairesdidnotrevealdiagnoses
At the first and last visits,parents completed a health and at the early age of recruitment (Tab.2). Because this study
demographic form. Exclusion criteria were defined a priori. was a home-based community study, medical records were
However,insome cases,exclusion could onlybe determined notavailableandourprojectcloselyapproximatedconditions
from post-intervention questionnaires.Based on the outtake presentforEIservicesintheUnitedStates.
information, 14 infants were deemed ineligible due to neu- AnaprioriMonteCarlosimulation–basedpoweranalysis
rodegenerativediagnosesand/orseizuredisorderthatbecame indicated a necessary sample size of 152 infants to detect
uncontrolledduringthestudyperiod,221infantwasineligible short-term intervention effects with magnitudes of d = 0.66
due to a neurodegenerative diagnosis at baseline, 1 infant (reaching), d = 0.48 (sitting), d = 0.56 (problem solving),
was ineligible due to inadequate sitting at baseline, and 6 and d = 0.64 (global development), assuming 10% attri-
infantswereineligibleduetoBayleygrossmotorscores≤1.0 tion 3 months after baseline and given α = .05 and power
4 PrimaryOutcomesoftheSTART-PlayTrial
Table2. BaselineChildandFamilyCharacteristicsfortheTotalSampleandbyInterventionGroupa
AggregatedAcrossSeverity SignificantMotorDelayat MildMotorDelayat
Levels Baseline Baseline
Total
Variable
(N=112) UC-EI START-Play UC-EI START-Play UC-EI START-Play
Group Group Group Group Group Group
(n=55) (n=57) (n=25) (n=25) (n=30) (n=32)
Sex
Girls 42.9 47.3 38.6 56.0 32.0 40.0 43.8
Boys 57.1 52.7 61.4 44.0 68.0 60.0 56.3
Race
White 70.1 66.7 73.2 60.9 80.0 71.4 67.7 D
o
Black 10.3 11.8 8.9 26.1 4.0 0.0 12.9 w
Other 19.6 21.5 17.9 13.0 16.0 28.6 19.4 nlo
Ethnicity ad
Hispanic 17.6 13.5 21.4 8.3 20.0 17.9 22.6 ed
NotHispanic 82.4 86.5 78.6 91.7 80.0 82.1 77.4 fro
Prematurity-adjustedage,mean 10.80(2.59) 10.67(2.57) 10.93(2.63) 11.96(2.50) 12.04(2.84) 9.58(2.11) 10.07(2.12) m
(SD)mob h
Gestationalageatbirth,wk ttps
≥37 65.2 56.4 73.7 44.0c 84.0c 66.6 65.6 ://a
34–36 7.1 5.5 8.8 0.0c 4.0c 10.0 12.5 ca
32–33 6.3 10.9 1.8 16.0c 0.0c 6.7 3.1 de
25–31 12.5 12.7 12.2 20.0c 12.0c 6.7 12.5 m
<25 8.9 14.5 3.5 20.0c 0.0c 10.0 6.3 ic.o
Everhadproblemsseeingb 27.8 28.8 26.8 50.0 56.0 10.7 3.2 up
Everhadproblemshearing 18.5 25.0 12.5 29.2 24.0 21.4c 3.2c .co
Everhadproblemswithseizuresb 19.4 15.4 23.2 20.8 44.0 10.7 6.5 m/p
EtRhveeecrebirhvaaeiddnbebarraliynIinntjeurrvyenotriownatoevreorn 2766..29 2715..25 3708..92 3935..35 5824..00 1509..73 1733..33 tj/article
past3mob /1
0
Receivedprivatepractice 34.6 32.7 36.4 27.3 36.0 37.0 36.7 1
interventionoverpast3mo /2/p
Totalfrequencyoftherapy 4 4.5 4 6 5 2.5 2.5 z
a
sessions/mooverpast3mo, a2
medianb 32
Caregiverhighesteducationlevel /6
0
<HSdiploma/GED 2 0.0 3.6 0.0 4.2 0.0 3.2 5
6
HSdiploma/GED 13.3 16.0 10.9 13.0 20.8 18.5 3.2 33
Somecollege,training 25.7 26.0 25.5 30.4 16.6 22.2 32.2 1 b
certificate,orassociate’sdegree y
Bachelor’sdegree 25.7 24.0 27.3 39.2 41.7 11.2 16.2 ha
Postgraduatedegree 33.3 34.0 32.7 17.4 16.7 48.1 45.2 rb
o
Grosshouseholdincome,median 60,000– 79,999 60,000– 35,000– 80,000 80,000 45,000– u
79,999 79,999 44,999 59,999 rne
Affordancesinthehome,mean 0.72(0.27) 0.70(0.25) 0.74(0.29) 0.68(0.18) 0.80(0.31) 0.72(0.29) 0.67(0.26) r@
(SD) du
q
.e
aDataarereportedaspercentagesunlessotherwiseindicated.GED=generalequivalencydiploma;HS=highschool;START-Play=SittingTogetherand d
u
ReachingtoPlay;UC-EI=usualcare-earlyintervention.bSignificantdifferencesbetweenmilddelayandsignificantdelaygroups.cSignificantintervention o
groupdifferences(P<.05). n 2
7
F
e
b
approximately 0.80. Effect sizes were estimated from prior forlaterscoringbyresearchersmaskedtogroupassignment. rua
studies.3,4 Giventhatonly134infantswererandomizedand Interrater reliability, calculated between coders for 20% of ry 2
that,ofthose,only112metthecriteriatobeincludedinthe the data, was good to excellent, with ICCs ranging from 02
analyses,the group comparisons presented in this article are 0.80 to 0.98 for all measures.24 Datavyu25 was used for 1
underpowered. Implications are discussed in the limitations behavioral coding. All assessments included in the clinical
section. trial are detailed in the protocol paper and briefly described
below.3
Procedures
A standardized reaching assessment and the Gross Motor
Allassessmentsandinterventionswereperformedconsistently Function Measure (GMFM) were administered at every
inthehome,daycaresetting,oranassessmentsite,asdictated visit. Frequency of contacts with an object presented to
by caregiver’s choice at the start of the study. Infants were infants when seated in a chair was behaviorally coded to
assessed at baseline and 1.5, 3, 6, and 12 months later by demonstrate reaching ability.3 The GMFM sitting dimen-
a trained, reliable assessor masked with regard to group sion from the GMFM-88 was used to quantify sitting
assignment.All assessments were video recorded and stored ability.
Harbourneetal 5
Frequency of self-initiated problem solving was assessed and indicates good adherence by the START-Play therapists
using the Assessment of Problem Solving in Play (APSP), andstrongprogramdifferentiationbetweenSTART-Playand
a modification of the Early Problem Solving Indicator for UC-EI.30
infantswithmotorimpairments.26,27 Infantsinteractedwith
3toysetseachfor2minuteswhileinsupportedsitting.Behav- StatisticalAnalysis
ioralcodingdocumentedthefrequencyof5behaviors:look,
Piecewiselinearmixedmodelingwasperformedtoaddressthe
simple explore, complex explore, function, or solution.25,27
study questions. The specific analytic models and equations
A validated formula weighted the difficulty of the behaviors
are in Supplementary Appendix C. Linear mixed modeling
tocalculateasingleproblem-solvingscoresensitivetochange
wasnecessarytoaccountforrepeatedmeasuresnestedwithin
overtime.27
infants. Piecewise modeling, using individually varying time
TheBayleycognition,grossandfinemotor,andexpressive
points, allowed separate slopes to be estimated across the D
andreceptivecommunicationscaleswereadministeredatall o
intervention(baselineto3monthsafterstartofintervention) w
visits except 1.5 months.19 Raw scores were used to assess n
and postintervention (3–12 months) phases and accounted lo
change over time and absolute growth,rather than standard for variation in the time between assessments across infants. ade
scores,whichprovideacomparisonwithatypicallydevelop- d
ingpopulation.28 All models controlled for intercept-level differences by site fro
as well as intercept- and slope-level differences by baseline- m
adjusted age and motor severity. Intervention effects were h
Intervention derived via intervention × slope interaction terms. Three- ttps
The START-Play intervention was provided in collaboration way(intervention×slope×severity)interactiontermswere ://a
with at least 1 parent or caregiver 2 times per week for c
subsequently added to the models to obtain intervention ad
3months,upto24visits(mean=21;SD=3.9).Dependingon e
effectsstratifiedbyseverity.Long-termresultsarereportedas m
t(hSDe i=nf4a.n4t’ms bineuhtaevsi)oirnallesntgatthe,,sweistshioanrsaanvgeeraogfe4d05.81.t5o6m0inmuitnes- tahnedspuomstoinftsehrovertn-ttieornm((30-–t3om12o-nmthosnathfteforlsltoawrt-uopf)inetfefrevcetsn.tion) ic.oup
utes.Experienced,licensedphysicaltherapistsateachsitewere Data were analyzed using Mplus Version 8 software.31 .co
trained in the provision of START-Play by an investigator. m
Tthhareanoidnrsei-ntoigcnaftlorraeivanilidlneignnwcteeirtvhseunipntpfioaonnrtitssint,sogninkgcoelyuindgiendcgrrireteidvqiiueenewtasno,dfinpfe-eperdetirbnsaoecnnkt, AiiFnnudcflohllureidmnriefnaodtgrimoitnnoattmaihoneanxianmimntaeaunxlymtimsioelusnikm-reteollig-ihtakorreeodlaidlhteoswpsoeidtrohsfaprsedoscrubtomiuvpseeot,suSadtE3lal2tecasuatassirmeinesagmwtifioeusrnsle-l. /ptj/article
on treatment sessions, and refresher training. Training was /1
ing at random. To meet this assumption, baseline charac- 0
provided for the START-Play interventionists during on-site teristics associated with dropout, or that differed between 1/2
1-on-1sessionswiththetherapistsfor3days,withfollow-up /p
intervention groups within severity levels, were included as z
intervention videos with children until the therapist reached auxiliary variables in a saturated correlates model.33 Signif- aa2
preset adherence levels of the intervention. UC-EI was not 3
icance was based on α = .05. Hedges g, corrected for small 2
affectedortrainedforthisstudy;rather,videodocumentation /6
sample bias,was calculated as a measure of effect size using 0
allowed examination of activities that comprised usual care the model-predicted group differences in rate of change in 563
in the 5 regions of the study. UC-EI was performed by the 3
the numerator and the pooled SD estimated from the 3- 1
usual interventionist of the individual child; no training or b
or 12-month assessment (for short- and long-term effects, y
influence from the START-Play study was imposed on those respectively) in the denominator.34 Standardized differences ha
therapists.Examplesofcontentanddifferencesnotedbetween of 0.20, 0.50, and 0.80 were interpreted as small, medium, rbo
theSTART-PlayinterventionandUC-EIareshowninTable1. u
surAess pfoarrtadohfetrheencmeeathnoddporlooggrya,mfiddeilfifteyreonftiianttieornvewnteiroenevmaelua-- ainntderlparregteedefafescstus,brsetsapnetcivtievlyelyim,wpoitrhtatnhto.s3e5,036.2(p514o)rlargerbeing rner@
d
ated throughout the 4 years of the study. Adherence to the u
q
interventionprotocolwasevaluatedregularlyandcompared .e
Results d
withapriorithresholdsforcompliance.Atleast1sessionfor u o
each infant in the START-Play group and 1 UC-EI interven- Aggregating across severity levels, there were no differences n 2
tion session (for 54% of the UC-EI therapists who provided between the intervention groups at baseline. Among infants 7 F
consent) were video recorded.3 Based on a subsample of 64 withsignificantmotordelayatbaseline,theUC-EIgroupwas eb
videos,interventionistsintheSTART-Playgroup,onaverage, more likely to be born premature. Infants with significant ru
a
utilizedatleast1keyingredientduringeachminutefor>90% delaysweremorelikelytohaveabraininjury(43%vs12%) ry
2
ofthetotalsessionlength(mean=48minutes;SD=9.6min- thaninfantswithmilddelays.Amonginfantswithmildmotor 0
2
utes). Program differentiation variables were defined and delay, the UC-EI group was more likely to have problems 1
codedtodocumentkeydifferencesbetweenSTART-Playand hearing.Atbaseline,thoseinthemildgroupwerelesslikelyto
UC-EIintervention.29,30 Specificdifferencescodedassignifi- haveabraininjury,problemsseeing,orahistoryofinfantile
cantlydifferent(P≤.001)betweenSTART-Playintervention seizures (Tab.2). Infants in the mild group were younger at
and UC-EI intervention were greater motor assistance than baselinewithalowerfrequencyoftherapyservices.Thetotal
needed (11% of the sessions for START-Play and 35% of numbersoftherapysessionspermonthwere4.5fortheaggre-
thesessionsforUC-EI),rigidadherencetothecorrectwayof gatedgroup,5.5forthechildrenwithsignificantdelays,and
moving(9%ofthesessionsforSTART-Playand51%ofthe 2.5forthechildrenwithmilddelays;therewerenosignificant
sessions for UC-EI), and intervention activities not START- differences in the number of therapy sessions between the
Playrelated(6%ofthesessionsforSTART-Playand85%of START-PlayandUC-EIgroupswithintheaggregatedgroup,
thesessionsforUC-EI).Furtherinformationondifferencesin the group with mild delays, or the group with significant
the interventions and fidelity appear in another manuscript delays(Tab.2).
6 PrimaryOutcomesoftheSTART-PlayTrial
Table3. BaselineandShort-andLong-TermInterventionEffectSizes(Hedgesg)andStatisticalSignificancea
AggregatedAcrossSeverity SignificantMotorDelayat
MildMotorDelayatBaseline
Levels Baseline
Outcome
Short Long Short Long Short Long
Baseline Baseline Baseline
Term Term Term Term Term Term
Reaching(totaltoycontactsperminute) −0.11 0.06 0.23 −0.48b 0.18 0.71c 0.14 0.00 −0.35b
GMFMsitting 0.00 0.21c 0.13 −0.06 0.34b 0.31b 0.03 0.21 −0.16
APSP 0.16 −0.03 0.07 −0.13 0.41c 0.17 0.50c −0.51d −0.03
Bayleycognition 0.03 0.18 0.08 −0.09 0.43c 0.17 0.18 −0.06 0.01
Bayleygrossmotor 0.11 0.09 −0.04 −0.05 0.26b 0.14 0.33b −0.03 −0.49b
Bayleyfinemotor 0.05 0.20c 0.25c −0.01 0.28c 0.45c 0.17 0.22 0.12 Do
Bayleyreceptivecommunication 0.24 0.21 0.21 0.22 0.02 0.10 0.26b 0.38c 0.33b wn
Bayleyexpressivecommunication 0.11 0.09 0.09 −0.10 0.21 0.15 0.28b −0.01 0.04 loa
d
e
daSifhfeorretn-tceersm.E(fbfaecsetslinweerteon3otmsoignafiftiecrasnttaartndofdiindtnerovtehnativoens)uabnsdtanlotnivge-ltyerimmp(obratsaenlitnseizteosu1n2lemssooatfhteerrwsitsaertinodficinatteedrv.eAnPtiSoPn=)eAffsescetsssmweenrteoafdPjurostbeldemfoSroblvaisneglinine d fro
m
Play;Bayley=BayleyScalesofInfantandToddlerDevelopment,ThirdEdition;GMFM=GrossMotorFunctionMeasure;START-Play=SittingTogether
aanpdosRiteiavcehvinalguteofaPvlaoyr;edUCth-eESIT=AuRsuTa-Pllcaayreg-reoaurply,ianntderavennetgioanti.vbeTvhaelueefffeacvtowreadstnhoetUstCa-tEisItigcraolluyps.igcTnihfeiceafnftecbtuwtahsadstaatissutbicsatlalnytsivigenlyifiicmapnotr(tPan<ts.0iz5e)(ign≥fav0o.2r5o)f; https
theSTART-Playgroup.dTheeffectwasstatisticallysignificant(P<.05)infavoroftheUC-EIgroup. ://a
c
a
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e
m
ic
.o
u
Table3 summarizes the statistical significance and magni- fine motor (g = 0.28) scores and substantively important p
.c
tude of the baseline, short-term (baseline to 3 months after but not significant effects on GMFM sitting (g = 0.34) and o
m
startofintervention),andlong-term(baselineto12months) Bayley gross motor (g = 0.26) scores. Among infants with /p
effects by group (aggregated across severity levels vs infants mild delays (Figs.2Band3), there were significant negative tj/a
withsignificantmotordelaysatbaselinevsinfantswithmild effects on APSP scores (g = −0.51) and positive effects on rtic
le
motor delays at baseline), and Figures2 and 3 provide a Bayleyreceptivecommunicationscores(g=0.38). /1
graphicalrepresentationtheresults.Figure2showstheresults 01
in a format mirroring our theory of change, and Figure3 Long-termEffects:Baselineto12MonthsAfter /2/p
graphsthepredictedoutcometrajectoriesbyseveritygroupin StartofIntervention za
a
bothUC-EIandSTART-Play.SupplementaryTable1inSup- Aggregating across severity levels, there was a significant 23
plementary Appendix D provides the raw estimates and SEs positive long-term effect of the START-Play intervention on 2/6
aswellasexactPvaluesforthetargeteffects.Supplementary Bayley fine motor scores (g = 0.25). Among infants with 05
6
Tables2to9inSupplementaryAppendixDprovidetheesti- significantmotordelays,thereweresignificantpositiveeffects 33
mated coefficients corresponding to the statistical equations onreachingfrequency(g=0.71)andBayleyfinemotorscores 1 b
usedtoderivetheinterventioneffects.Below,weorganizeour (g = 0.45) and substantively important but not significant y h
summary of the results by effect, and within each effect, by effects on GMFM sitting (g = 0.31) (Figs.2 and 3). There arb
group. werenosignificantlong-termeffectsamonginfantswithmild ou
delays,butthereweresubstantivelyimportantnegativeeffects rn
e
BaselineComparisons on reaching frequency (g = −0.35) and Bayley gross motor r@
There were no significant group differences at baseline in scores (g = −0.49) and positive effects on Bayley receptive du
q
infants’globaldevelopmentwhenaggregatingacrossseverity communicationscores(g=0.33)(Figs.2and3). .e
d
levelsoramonginfantswithsignificantdelays.However,there u
o
were substantively important but nonsignificant differences RoleoftheFundingSource n
favoringtheUC-EIgroupinreachingfrequency(g =−0.48) Thefundingsourcehadnoroleinthestudy’sdesign,conduct, 27 F
among infants with significant motor delays.Among infants andreporting. e
b
with mild delays, those in the START-Play group had sig- ru
a
nificantly higher APSP scores (g = 0.50) and substantively ry
important but not significantly higher Bayley gross motor Discussion 20
2
(g=0.33),receptivecommunication(g=0.26),andexpressive 1
Overall, the infants with significant motor delays who
communication(g=0.28)skills.
receivedSTART-Playinterventionshowedstatisticallysignif-
icantorqualifiedpositiveeffects(substantivelyimportant)36
Short-termEffects:Baselineto3MonthsAfter
changesinsitting,reaching,finemotor,problemsolving,and
StartofIntervention(START-Play
global development during the study. However, differences
InterventionPeriod)
betweentheSTART-PlayandUC-EIgroupswerenotnotable
Aggregating across severity levels, there were significant in infants with mild motor delays. The START-Play study
positive short-term effects of the START-Play intervention results are best understood by examining the baseline
on GMFM sitting (g = 0.21) and Bayley fine motor skills characteristics of the participants and the division of infants
(g = 0.20). Among infants with significant motor delay intosignificantandmildmotordelaygroups.Thisdiscussion
(Figs.2Aand3), there were significant positive effects on isorganizedfortheshortandlong-termresults,followedby
APSP (g = 0.41), Bayley cognition (g = 0.43), and Bayley possibleclinicalimplications.
Harbourneetal 7
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Figure2.Short-term(0–3months)andlong-term(0–12months)interventioneffectsforparticipantswithsignificant(A)ormild(B)motordelayatthe 2
7
baselinestudyvisit.Greencellsrepresentstatisticallysignificanteffects(P<.05)infavoroftheSittingTogetherandReachingtoPlay(START-Play) F
e
group;redcellsrepresentstatisticallysignificanteffects(P<.05)infavoroftheusualcare-earlyintervention(UC-EI)group;yellowcellsrepresent b
effectsthatwerenotstatisticallysignificantbuthadsubstantivelyimportantsizes(g≥0.25),withthedirectionoftheeffectsnotedasfavoringthe rua
START-Play(SP)ortheUC-EIgroup;andwhitecellsrepresenteffectsthatwerenotsignificantanddidnothavesubstantivelyimportantsizes. ry
2
0
2
1
DifferencesBetweenMildandSevere DifferencesinShort-termOutcomes
GroupingsatBaseline There were significant, positive differences in problem
InfantsintheUC-EIandSTART-Playgroupsshowedasimilar solving, fine motor, and cognitive ability in the short term
distributionofdelays,impairments,andsupports.Therewas (3 months after start of intervention) for the infants with
arangeofparticipantsinthisstudy,andtobetterunderstand significant delays receiving START-Play. This suggests the
theimpactoftheinterventionacrossthisdiversesample,we key ingredients of START-Play can, in fact, facilitate global
examinedinfantswithmildandsignificantmotordelayssep- development.Inaddition,substantivelyimportantdifferences
arately.Infantsinthe2groupshaddifferentskills,needs,and in sitting and gross motor in favor of the START-Play
potential for change, which allows for better understanding group for infants with significant motor delays add to
of key intervention ingredients and optimal translation to developmental studies showing the important relationship
services.6 between improving sitting control and potential effects
8 PrimaryOutcomesoftheSTART-PlayTrial
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Figure3.Short-termandlong-termpredictedoutcometrajectoriesbyseveritygroup(usualcare-earlyintervention[UC-EI]andSittingTogetherand
ReachingtoPlay[SP]).0=preintervention;3=postintervention;APSP=AssessmentofProblemSolvinginPlay.
on problem-solving abilities and cognition in the short motor skill level of the infants in the mildly delayed group
term.8,10,11 nullified the effect of START-Play key ingredients. These
For the group with mild delays, the relationship between infants were sitting with greater independence at baseline
reachingandsittingimprovementfortheSTART-Playgroup and quickly became mobile. Thus, they were quite different
did not appear related to downstream effects on problem from the infants with significant motor delays. The other
solving or cognition. Possibly the overall higher baseline significantfindinginreceptivecommunicationinfavorofthe
Harbourneetal 9
START-Playgroupmayberelatedtotheincreasedpercentage gains may not translate to improved cognitive outcomes.
ofinfantsinthemildUC-EIgroupwithhearingdifficultiesor Consequently, the key ingredients of START-Play (Tab.1)
the greater amount of attention to communicated cognitive may reflect best practice for advancing motor and cognitive
constructsduringmovementinSTART-Playintervention. outcomes for infants with significant motor delays, but not
TheUC-EImilddelaysgroupshowedsignificantlygreater forinfantswithmildmotordelays.Itispossiblethatinfants
changes in problem solving in the short term. However, the whobecomemobile(asinthegroupofmildlydelayedinfants)
START-Play group was significantly better at problem solv- requiredifferentkeyingredientsforimprovedoutcomes.
ing at baseline on average, and by approximately the same The START-Play intervention incorporates practices that
magnitude,than the UC-EI group.In effect,the comparison the EI literature suggest promote developmental outcomes,
atthe3-monthtimepointmayrepresentatruedifferenceor such as intervention in the natural environment,coaching,a
maysimplyindicatearegressiontothemean,aphenomenon focusonthewholechild,andparticipationwithinmeaningful
D
in which individuals who, by chance, perform better than routines.8–14 It is important to note that the fidelity data o
w
expected at 1 time point are more likely to perform closer in this study suggest that, across the country, EI providers n
lo
to expectation at a subsequent assessment,and vice versa.37 might benefit from improved education regarding providing ad
e
This was the only significant difference between UC-EI and the right level of support, encouraging flexibility of move- d
START-PlayfavoringtheUC-EIgroup. ment, brainstorming with parents, and developing interven- fro
m
tion activities that focus on development across multiple h
DifferencesinLong-termOutcomes domains.29,30 This type of education could benefit a variety ttp
s
There were significant differences in favor of the START- ofEIprofessionalsworkingwithinfants,includingeducators, ://a
Play group in infants with significant motor delays noted occupationaltherapists,andphysicaltherapists. c
a
d
in reaching and Bayley fine motor scores. For infants with e
m
severe movement problems, enhancing reaching, grasping, Limitations ic
and manipulation abilities may take longer but is crucial Althoughwepoweredfortheprimaryaim,theinitialpower .ou
p
to facilitate cognition, communication, and performance of analysis was based on available data from preterm infants. .c
o
activitiesofdailyliving.Inaddition,substantivelyimportant This may not have been representative of the infants in this m
csihtTatinnhggee.slofnogr-ttehreminsfuabnsttsanintivtheleySiTmApRoTrt-aPnlatydgifrfoeurepnceexsisitnedthine smtotuilpddoyo.wrIensrigathndeidfiistctiauondnty,.moRuoertcodrruedciteimsliaoeynnwttooafsdinniovfitadnpetastrhtweohfgooroumurepitnibintaicasleludpsilooannn /ptj/article
group with mild motor delays showed advances in the UC- criteriaandoureventualexclusionofinfantswhodeveloped /1
0
EI group for reaching and gross motor ability. While the uncontrolled seizures limited the sample size and resulted in 1/2
gross motor finding may reflect a regression toward the lowpower.TheAPSP,althoughacompellingplayassessment /p
z
mean similar to short-term problem-solving findings, this for problem solving,may be quite motor biased.Testing for aa
2
also may reflect that START-Play intervention focused less cognitionandproblemsolvingininfantswithmotordeficits 3
2
on motor advancement alone but aimed to blend cognitive is difficult, especially in the natural home setting.38 Finally, /6
0
constructs with motor activities. Substantive positive differ- the dose of intervention was not equal between groups.The 56
3
enceswerenotedforthemildSTART-Playgroupinreceptive START-Play intervention was provided in addition to UC-EI 3
1
communication. As stated above, increased communication during the short interval (12 weeks) of study intervention, b
y
andinteractionwithcognitiveconstructsduringtheSTART- making it unethical to withdraw from community services. h
a
Play intervention may be reflected or this may reflect that The significant limitations of this study,although large,pro- rb
o
hearing impairments were more prevalent among the mild vide guidance for future studies to address best practice for u
UC-EIgroup. EI. rne
r@
Implications du
Future Directions q
Key implications from this study indicate that there may be .e
d
motor and cognitive benefits of implementing the START- The START-Play intervention may include ingredients for u o
Play intervention for infants with significant but not mild bestpracticeduringearlytherapyforinfantswithsignificant n 2
motor delays. UC-EI alone may be sufficient for advancing motordelays.Futuredirectionsincludeanalysisofmediators 7 F
motor outcomes and problem solving for infants with mild andmoderatorsoftheintervention,comparisonsfordosageof eb
motor delay. A focus on fine motor and cognitive activities intervention while infants continue their usual early therapy ru
a
withinmotorinterventionmayhelptomaximizeoutcomesfor programs, comparison with dose-matched intervention, and ry
2
infantswithsignificantmotordelaysandmaybeaneglected modificationofSTART-Playactivitiesforinfantswhoachieve 0
2
areaincurrentEI. mobilityduringtheintervention. 1
However, the lack of maintenance in gains during the
long-term follow-up phase suggests the need for continued
Author Contributions
focus on areas emphasized in START-Play for infants with
significantmotordelays.Eitheralongerperiodofintervention Concept/idea/researchdesign:R.Harbourne,S.Dusing,M.Lobo,
(>3months)ora“booster”ofSTART-Playinterventionata S.Westcott-McCoy,N.Koziol,L.-Y.Hsu,E.Marcinowski,I.Babik,
J.Bovaird,S.Sheridan
latertimepointmayhelptoextendtheeffectonglobaldevel-
Writing:R.Harbourne,S.Dusing,M.Lobo,S.Westcott-McCoy,
opment to the 12-month point or beyond, but this requires
N.Koziol,E.Marcinowski,I.Babik,A.Cunha,M.An
furtherstudy.
Datacollection:R.Harbourne,S.Dusing,S.Westcott-McCoy,L-Y.Hsu,
In contrast, minimal differences between groups in the E.Marcinowski,I.Babik,A.Cunha,M.An,H.-J.Chang
infantswithmildmotordelayssuggeststhatSTART-Playhas Dataanalysis:S.Dusing,M.Lobo,S.Westcott-McCoy,N.Koziol,
little added value for these infants. These short-term motor L.-Y.Hsu,S.Willett,M.An,J.Bovaird
10 PrimaryOutcomesoftheSTART-PlayTrial
Projectmanagement:R.Harbourne,S.Dusing,M.Lobo, 7. ChangH,HsuL,McCoySW,HarbourneRT.Servicedeliveryof
S.Westcott-McCoy,N.Koziol,L.-Y.Hsu,S.Willett,E.Marcinowski, PTsandOTsinearlyintervention:howarewedoing? PedPhys
H.-J.Chang,J.Bovaird Ther.2018;30:E15.
Fundprocurement:R.Harbourne,S.Dusing,M.Lobo, 8. SpittleA,OrtonJ,AndersonPJ,BoydR,DoyleLW.Earlydevelop-
S.Westcott-McCoy,J.Bovaird mentalinterventionprogrammesprovidedposthospitaldischarge
Providingparticipants:R.Harbourne,S.Dusing,S.Westcott-McCoy, to prevent motor and cognitive impairment in preterm infants.
S.Willett CochraneDatabaseSystRev.2015;11:CD005495.
Providingfacilities/equipment:R.Harbourne,S.Dusing,M.Lobo, 9. Morgan C,Darrah J,Gordon AM,et al.Effectiveness of motor
S.Westcott-McCoy,S.Willett,J.Bovaird interventions in infants with cerebral palsy: a systematic review.
Providinginstitutionalliaisons:S.Westcott-McCoy,S.Willett DevMedChildNeurol.2016;58:900–909.
Consultation(includingreviewofmanuscriptbeforesubmitting): 10. HarbourneRT,BergerSE.Embodiedcognitioninpractice:explor-
N.Koziol,L.-Y.Hsu,S.Willett,J.Bovaird,S.Sheridan ing effects of a motor-based problem-solving intervention. Phys
D
Ther.2019;99:786–796. o
w
11. Ryalls BO, Harbourne R, Kelly-Vance L, Wickstrom J, Stergiou n
Acknowledgments N,Kyvelidou A.A perceptual motor intervention improves play loa
d
behaviorininfantswithmoderatetoseverecerebralpalsy.Front e
Theauthorsextendtheirheartfeltthankstothefamilies,children,and d
communitytherapistswhoparticipatedinthisstudy.Theauthorsare Psych.2016;7:643. fro
12. Lobo MA, Harbourne RT, Dusing SC, McCoy SW. Grounding m
alsogratefulforthetalentedteamofSTART-Playinterventionistsand early intervention: physical therapy cannot just be about motor h
abSshlesae:asMrsooanrdsdwBirehooAwsuenbu,unLcwhyonavnne,erJiaCnmgapieenoBtuhanur,nsiEhaimslml,ilAyanmDdyrheBawery,deBwrsrodorookrkfme,KaFdeieltltytehrBiesor,pssoLosilssaia-, 13. lsSekmsislioltshnasLnf,yromGmaosrbseea.rbPMiheys.s.TAThrhteeifrd.Le2vi0fee1l.o32p;09m03e5:n9;1t41–o:1f10e33m–.2b9o.diedcognition:six ttps://aca
Hennen,CierraMaloney,HeidiReelfs,ShawnRundell,LisaSchwarcz, d
14. Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. e
Jaclynn Stankus,Tracy Stoner,Tanya Tripathi,Cathy Van Drew,and m
AllisonYokum. Atocimomprpoavreisosnittionfginptoesrtvuernatliocnosntfroorl:inafacnlitnsicwalitthriacle.rePbhryasl Tpahlesry. ic.o
u
2010;90:1881–1898. p.c
Ethics Approval 15. Soska KC, Adolph KE. Postural position constrains multimodal o
m
objectexplorationininfants.InfDent.2014;19:138–161. /p
Ethicalapprovalwasobtainedfromtheinstitutionalreviewboardsat 16. HarbourneRT,RyallsB,StergiouN.Sittingandlooking:acom- tj/a
allsites. parisonofstabilityandvisualexplorationininfantswithtypical rtic
developmentandinfantswithmotordelay.PhysOccupTherPed. le
/1
Funding 2014;34:197–212. 0
1
17. Iverson JM. Developing communication in a developing body: /2
ThisstudywasfundedbytheUSDepartmentofEducation,Instituteof therelationshipbetweenmotordevelopmentandcommunication /p
z
Education Sciences; National Center for Special Education Research, development.JInfantComm.2010;37:229–261. aa
EarlyInterventionandEarlyLearninginSpecialEducation,Awardno. 18. WHO Multicentre Growth Reference Study Group and de Onis 23
R324A150103. M.WHOmotordevelopmentstudy:windowsofachievementfor 2/6
0
sixgrossmotordevelopmentmilestones.ActaPaediatr.2006;95: 5
6
Clinical Trial or Systematic Review 86–95. 3
3
Registration 19. BayleyN.BayleyScalesofInfantandToddlerDevelopment.3rd 1 b
ed.SanAntonio,TX:HarcourtAssessment;2006. y
ThistrialisregisteredatClinicalTrials.gov(identifier:NCT02593825). 20. PalisanoR,RosenUC-EImP,WalterS,RussellD,WoodE,Galuppi ha
B.Developmentandreliabilityofasystemtoclassifygrossmotor rb
o
function in infants with cerebral palsy. Dev Med Child Neurol. u
Disclosures rn
1997;39:214–223. e
21. EliassonAC,Krumlinde-SundholmL,RösbladB,etal.Themanual r@
S.DusingreportsreceivingcontinuingeducationroyaltiesfromMed- d
bridge.TheauthorscompletedtheICMJEFormforDisclosureofPoten- abilityclassificationsystem(MACS)forinfantswithcerebralpalsy: uq
tialConflictsofInterestandreportednootherconflictsofinterest. scaledevelopmentandevidenceofvalidityandreliability.DevMed .ed
ChildNeurol.2006;48:549–554. u
22. GibbsSN,ChoiJ,KhilfehI,AhmedKH,YermilovI,SegalE.The on
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