Viewing Study NCT03962517



Ignite Creation Date: 2024-05-06 @ 1:13 PM
Last Modification Date: 2024-10-26 @ 1:10 PM
Study NCT ID: NCT03962517
Status: COMPLETED
Last Update Posted: 2020-04-02
First Post: 2019-05-20

Brief Title: Effect of GEMS-H on Locomotor Function in Adults
Sponsor: Samsung Electronics
Organization: Samsung Electronics

Study Overview

Official Title: Effect of GEMS-H on Locomotor Function in Adults
Status: COMPLETED
Status Verified Date: 2020-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip GEMS-H vs training without the GEMS-H on locomotor function in adults The investigator hypothesizes that long-term GEMS-H use would improve locomotor function Specifically individuals in the GEMS-H group will show faster gait speed compared to those in the control group
Detailed Description: The GEMS-H is a hip-type assist device developed by Samsung Electronics The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints The device weighs 21kg and has 2 brushless direct current motors running on a rechargeable lithium ion battery The normal operation time for the device is 2 hours It is controlled through a custom built application on a hand held tablet

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip GEMS-H vs training without the GEMS-H on locomotor function in adults The investigator hypothesizes that long-term GEMS-H use would improve locomotor function Specifically individuals in the GEMS-H group will show faster gait speed compared to those in the control group

Participants will be scheduled for 18 sessions of training randomly placed either in GEMS-H training group or traditional training group without the GEM-H plus 5 sessions of testing pre-training mid-test after the 9 sessions of training post-training 1 month follow-up and 3 month follow-up after the 18 sessions training completed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None