Viewing Study NCT04610190



Ignite Creation Date: 2024-05-06 @ 3:23 PM
Last Modification Date: 2024-10-26 @ 1:48 PM
Study NCT ID: NCT04610190
Status: COMPLETED
Last Update Posted: 2023-03-01
First Post: 2020-10-26

Brief Title: Useability Test to the Wearable Walking-assist Robot GEMS-H for Normal Adults Including the Elderly
Sponsor: Yun-Hee Kim
Organization: Samsung Medical Center

Study Overview

Official Title: Useability Test of Gait Enhancing and Motivating System-Hip GEMS-H
Status: COMPLETED
Status Verified Date: 2023-02
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 userbility and satisfaction of functional gait training with the Gait Enhancing and Motivating System-Hip type GEMS-H on locomotor function in normal adults including the elderly
Detailed Description: The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of Technology 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 The GEMS-H is available in three sizes to fit various waisthip sizes small medium and large The width of each version can be adjusted further to fit individual body size within the circumference range Also the thigh frames are available in three sizes large medium and small for different leg lengths It is controlled through a custom built application on a hand held tablet

Participants will be normal adults with community-dwelling older adults aged 19-85

Participants will be scheduled for 24 training sessions of training plus 3 sessions of testing pre-training mid-test after the 12 sessions of training post-training

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