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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.
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
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
.
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