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

Gait Disorders in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106881
• Other study ID #: 2021-04-058
• Status: Completed
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders in Old Age

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 meter walk test from baseline in gait speed	Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."	Baseline, After 45minutes of functional gait training (one-time experience)
Secondary	Change in Timed Up and Go test (TUG) from baseline in balance	Measure of dynamic balance function. 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.	Baseline, After 45minutes of functional gait training (one-time experience)
Secondary	Changes in Short Physical Performance Battery (SPPB) from baseline	SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.	Baseline, After 45minutes of functional gait training (one-time experience)
Secondary	Changes in Four Square Step Test (FSST) from baseline	FSST is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward.	Baseline, After 45minutes of functional gait training (one-time experience)
Secondary	Change in 6 minute walk test (6MWT) from Baseline	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.	Baseline, After 45minutes of functional gait training (one-time experience)
Secondary	User Satisfaction Questionnaire	We evaluate the satisfaction questionnaire for GEMS-H use.	After 45minutes of functional gait training (one-time experience)