Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page78of79
11.3.Summaryofstudies
Clinicaltrialsummary(Pivotalstudy)–from2019.11

Title
SafetyandEfficacyofSamsungGEMS‐HDevicetoimproveFunctionalWalkingAbility
inOutpatientStrokeRehabilitation.
ProtocolNumber STU00210372
Methodology Interventionalstudy
StudyDuration 1year
StudyCenter(s) Singlesite,multipleclinicswithinSRAL’sflagshiphospitalanditsoutpatientclinics
Objectives
Primaryobjectives
1) To determine safety and efficacy of Samsung GEMS‐H hip assist exoskeleton
duringphysicaltherapycareinanoutpatientsettingforpoststrokeindividuals.
2) Todeterminetheeffectongaitspeed,asassessedbythe10meterwalk test,
after gait training using Samsung GEMS‐H device in an outpatient setting for
poststrokeindividuals.

Secondaryobjectives
1) Todeterminethe effectonfunctionalwalkingendurance,asassessedbythe6
minutewalktest,oftaskspecifictrainingwiththeSamsungGEMS‐Hdeviceinan
outpatientsettingforpoststrokeindividuals.
2) Todeterminetheeffectonfunctionalbalance,asassessedbytheBergBalance
Scale, Functional Gait Assessment and Five Times Sit to Stand, of task specific
trainingwiththeSamsungGEMSdeviceinanoutpatientsettingforpoststroke
individuals.
Endpoints
The outcome measures will be assessed prior to the start of thetraining,after9
sessions, after 18sessions, and a 1 monthfollow up testingvisit,whichwillbethe
endpointsofthestudy.Measuresrelatedtosafetywillbeassessedatthestartand
end of each session. The outcome measures will be collected without using the
GEMS‐Hdevice.
NumberofSubjects 30
DiagnosisandMain
InclusionCriteria
Cerebrovascular accident(CVA), post 30 days, gait speed between 0.4 m/s and 0.8
m/s,MMSE>17,unsupportedsitting>30s,walkatleast10mwithassistancefroma
maximumofoneperson,followinstructions,physicianclearanceforparticipation
StudyProduct(s),Dose,
Route,Regimen
SamsungGEMS‐Hdeviceinoutpatientphysicaltherapy
Durationof
administration
18SessionsofOutpatientPhysicalTherapy+4Sessionsoftesting+2TMSsessions
Environmentofuse
Hospital's internal facilities (hallways)
–
stairs, ramps, curbs, uneven surfaces,
indoors.
AllthetrainingconditionsareADAcompliantwithslopeslessthan5degrees.