Gait Disorders in Old AgeNCT04610190
Useability Test to the Wearable Walking-assist Robot (GEMS-H) for Normal Adults Including the Elderly
A study testing Training with Gait Enhancing and Motivating System (GEMS-H) Robot in people with Gait Disorders in Old Age, run by Yun-Hee Kim at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders in Old Age
- What is being tested?
- Training with Gait Enhancing and Motivating System (GEMS-H) Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 19 - 85 years
- Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Useability Test of Gait Enhancing and Motivating System-Hip (GEMS-H)
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.
Read the detailed 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).
- Conditions
- Gait Disorders in Old Age
- Being tested
- Training with Gait Enhancing and Motivating System (GEMS-H) Robot
- Keywords
- Wearable hip assist robot, Gait, User test, Robot gait training, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with Gait Enhancing and Motivating System (GEMS-H) RobotDevice
Also called Training with GEMS-H
Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.
| Study group | Role | What they receive |
|---|---|---|
| Training with Gait Enhancing and Motivating System (GEMS-H) Robot | Experimental | Training consists of 15 minutes task-specific training and 20-30 minutes functional gait training on varied environments with device. Receives: Device: Training with Gait Enhancing and Motivating System (GEMS-H) Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Secondary outcomes (11)
Change in Berg Balance Scale (BBS) from baseline in balance
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Changes in Functional Reach Test (FRT) from baseline
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Changes in EuroQol-5D (EQ-5D) from baseline
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Changes in Fall Efficacy Scale-Korean (FES-K) from baseline
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Change in Muscle Strength from Baseline
The maximal isometric strength of the 12 muscles in lower extremity will be measured with digital muscle testing device.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Change in Geriatric Depression Scale (GDS) from Baseline
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
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.
Measured: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
User Satisfaction Questionnaire
We evaluate the satisfaction questionnaire for GEMS-H use.
Measured: after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start4 Nov 2020
- Primary completion31 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun-Hee Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Sponsor-investigator, Yun-Hee Kim, Samsung Medical Center
- Investigators
- Yun-Hee Kim, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610190
- Sponsor's protocol ID
- 2020-10-016
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SH, Kim E, Kim J, Lee HJ, Kim YH. Robot-assisted exercise improves gait and physical function in older adults: a usability study. BMC Geriatr. 2025 Mar 22;25(1):192. doi: 10.1186/s12877-025-05811-1.
PubMed 40121407
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Useability Test of Gait Enhancing and Motivating System-Hip (GEMS-H)
- ClinicalTrials.gov ID
- NCT04610190
- Acronym / sponsor ID
- 2020-10-016
- Conditions
- Gait Disorders in Old Age
- Keywords
- Wearable hip assist robot, Gait, User test, Robot gait training, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yun-Hee KimUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training with Gait Enhancing and Motivating System (GEMS-H) Robot | Experimental | Device: Training with Gait Enhancing and Motivating System (GEMS-H) RobotTraining consists of 15 minutes task-specific training and 20-30 minutes functional gait training on varied environments with device. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 19 - 85 years
- Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with Gait Enhancing and Motivating System (GEMS-H) RobotAlso: Training with GEMS-HTraining consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device. | Device | Training with Gait Enhancing and Motivating System (GEMS-H) Robot |
Primary outcome
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."
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
User Satisfaction Questionnaire
Time frame: after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 40121407Lee SH, Kim E, Kim J, Lee HJ, Kim YH. Robot-assisted exercise improves gait and physical function in older adults: a usability study. BMC Geriatr. 2025 Mar 22;25(1):192. doi: 10.1186/s12877-025-05811-1.
- Individual participant dataSharing planned: No
Related trials for Gait Disorders in Old Age
Recruiting
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Peripheral Neuropathies, Peripheral Neuropathy Due to Chemotherapy
Recruiting
Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults
Frail Elderly, Fall
Not yet recruiting
Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes
Balance, Gait
RecruitingObservational study
MOBility Disorders Assessment in Patients With Mild COGnitive Disorders
Cognitive Dysfunction
RecruitingObservational study
Impact of Force Control of Hip Abductor Muscles in Healthy Adults and Individuals With Parkinson's Disease
Aging, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Hee Kim, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with Gait Enhancing and Motivating System (GEMS-H) Robot in people with Gait Disorders in Old Age, run by Yun-Hee Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.