NCT04285060

Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke

Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Samsung Electronics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke
• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	Samsung GEMS-H	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.

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-02-26
• Last updated: 2021-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study