Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults

NCT ID: NCT05106881

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

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2022-06-30

Brief Summary

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The purpose of this study is to investigate the userbility and satisfaction of one-off 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.

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

* Healthy adults aged 40 to less than 85 years without a history of central nervous system disease

Exclusion Criteria

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-04-058

Identifier Type: -

Identifier Source: org_study_id

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