Useability Test to the Wearable Walking-assist Robot (GEMS-H) for Normal Adults Including the Elderly

NCT ID: NCT04610190

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2021-12-31

Brief Summary

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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

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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 2.1kg, 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 waist/hip 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).

Conditions

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Gait Disorders in Old Age

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Training with Gait Enhancing and Motivating System (GEMS-H) Robot

Training consists of 15 minutes task-specific training and 20-30 minutes functional gait training on varied environments with device.

Group Type EXPERIMENTAL

Training with Gait Enhancing and Motivating System (GEMS-H) Robot

Intervention Type DEVICE

Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.

Interventions

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Training with Gait Enhancing and Motivating System (GEMS-H) Robot

Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.

Intervention Type DEVICE

Other Intervention Names

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Training with GEMS-H

Eligibility Criteria

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Inclusion Criteria

* Age: 19 - 85 years
* Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.

Exclusion Criteria

* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* BMI ≥ 35 kg/m2
* Serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, Severe hypertension, severe weight bearing pain, life expectancy less than one year
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Electronics

INDUSTRY

Sponsor Role collaborator

Yun-Hee Kim

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yun-Hee Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee SH, Kim E, Kim J, Lee HJ, Kim YH. Robot-assisted exercise improves gait and physical function in older adults: a usability study. BMC Geriatr. 2025 Mar 22;25(1):192. doi: 10.1186/s12877-025-05811-1.

Reference Type DERIVED
PMID: 40121407 (View on PubMed)

Other Identifiers

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2020-10-016

Identifier Type: -

Identifier Source: org_study_id

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