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11.3. Summary of studies
Clinical trial summary (Pivotal study) – from 2019.11
Title
Protocol Number
Methodology
Study Duration
Study Center(s)
Objectives
Endpoints
Number of Subjects
Diagnosis and Main
Inclusion Criteria
Study Product(s), Dose,
Route, Regimen
Duration of
administration
Environment of use
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
Safety and Efficacy of Samsung GEMS‐H Device to improve Functional Walking Ability
in Outpatient Stroke Rehabilitation.
STU00210372
Interventional study
1 year
Single site, multiple clinics within SRAL's flagship hospital and its outpatient clinics
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.
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.
30
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
Samsung GEMS‐H device in outpatient physical therapy
18 Sessions of Outpatient Physical Therapy + 4 Sessions of testing + 2 TMS sessions
Hospital's internal facilities (hallways) – stairs, ramps, curbs, uneven surfaces,
indoors.
All the training conditions are ADA compliant with slopes less than 5 degrees.
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