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

Y

Yun-Hee Kim

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
Industry

Identifiers

NCT04610190
2020-10-016

Details and patient eligibility

About

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.

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.

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).

Enrollment

20 patients

Sex

All

Ages

19 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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