A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and chronic stroke.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
RECRUITINGIncidence of device related adverse events
Safety will be assessed by the number of device related adverse events throughout the duration of the study
Time frame: Duration of study participation (estimated 6 months)
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
Change in self-selected walking speed measured without the device
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
6 Minute Walk Test (6MWT)
Change in walking endurance measured without the device
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Berg Balance Scale (BBS)
Changes in functional balance measured without the device
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Functional Gait Assessment (FGA)
Change in functional balance measured without the device
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
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