Effect of GEMS-H on Locomotor Function in Adults

Samsung

Status: Completed

Conditions: Aged, 80 and Over; Adults; Aged; Middle Age

Treatments: Other: without Gait Enhancing and Motivating System-Hip (GEMS-H); Device: with Gait Enhancing and Motivating System-Hip (GEMS-H)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03962517

2019-04-063

Details and patient eligibility

About

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

Full description

The GEMS-H is a hip-type assist device developed by Samsung Electronics. 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. It is controlled through a custom built application on a hand held tablet.

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up and 3 month follow-up after the 18 sessions training completed).

Enrollment: 70 patients

Sex: All

Ages: 19 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 19 - 84 years
• No history of central nervous system related disease

Exclusion criteria

• Difficulty in walking due to conditions such as poor vision or fractures
• Height is less than 140cm or more than 185cm.
• Body mass index (BMI) greater than 35.
• Difficulty understanding and participating in the study such as those with cognitive problems or dementia.
• Subject who is at risk of falling during walking due to severe dizziness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Training with GEMS-H

Experimental group

Description:

Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month. Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with the device.

Treatment:

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

Training without GEMS-H

Active Comparator group

Description:

Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month. Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without the device.

Treatment:

Other: without Gait Enhancing and Motivating System-Hip (GEMS-H)