Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page77of79
Chapter11.Clinicalstudies
11.1.Introduction
In2019,Samsungconductedaclinical studyoftheGEMS‐H device primarilytoevaluatethe safetyandefficacyof
usingtheGEMS‐Hdeviceintheoutpatientsettingforpost‐strokerehabilitation.Inaddition,theeffectsonfunctional
ambulationarealsobeinginvestigatedinthisproject.
Theprimaryobjectivesare:
1) TodeterminesafetyandefficacyofSamsungGEMS‐H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.
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11.2.Adverseevents
There was no serious device related adverse events during the course of the clinical studies. The adverse events
reportedwereallskinrelated,suchasabrasionsandwereallresolvedwithadjustmentstothefitofthedevice
.
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