SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
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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 T 4 Sessions of t 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.
Summary of Contents for GEMS-H
Page 1: ...GEMS H Instructions for Use ...
Page 19: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 19 of 79 4 6 Marking plate ...
Page 52: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 52 of 79 6 7 3 3 Example of parameter control ...
Page 54: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 54 of 79 Error message examples ...
Page 64: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 64 of 79 ...
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