Skip to main content
OpenTrials
Completed

NCT Number: NCT04610190

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Other names: Training with GEMS-H

Primary outcomes

  1. Change in 10 meter walk test from baseline in gait speed

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    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."

Secondary outcomes

  1. Change in Berg Balance Scale (BBS) from baseline in balance

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    Measure of balance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56.

  2. Change in Timed Up and Go test (TUG) from baseline in balance

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    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.

  3. Changes in Functional Reach Test (FRT) from baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    FRT is a single item test developed as a quick screen for balance problems. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.

  4. Changes in Short Physical Performance Battery (SPPB) from baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    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.

  5. Changes in Four Square Step Test (FSST) from baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    FSST is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward.

  6. Changes in EuroQol-5D (EQ-5D) from baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are.

  7. Changes in Fall Efficacy Scale-Korean (FES-K) from baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    FES-K is the measures of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice. A 10-item self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population.

  8. Change in Muscle Strength from Baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    The maximal isometric strength of the 12 muscles in lower extremity will be measured with digital muscle testing device.

  9. Change in Geriatric Depression Scale (GDS) from Baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    GDS is a 15-item self-report assessment used to identify depression in the elderly. A score of 0 to 5 is normal. A score greater than 5 suggests depression.

  10. Change in 6 minute walk test (6MWT) from Baseline

    Time frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    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.

  11. User Satisfaction Questionnaire

    Time frame: after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

    We evaluate the satisfaction questionnaire for GEMS-H use.

Sponsors and collaborators

Lead sponsor

Yun-Hee Kim

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

Useability Test of Gait Enhancing and Motivating System-Hip (GEMS-H)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.