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

Samsung Medical Center

Status: Completed

Conditions: Gait Disorders in Old Age

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05106881

2021-04-058

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 225 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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