Gait Disorders in Old AgeNCT05106881
Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
A study testing Training with Gait Enhancing and Motivating System (GEMS-H) Robot in people with Gait Disorders in Old Age, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 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
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2021to 30 Jun 2022
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 40 to less than 85 years without a history of central nervous system disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- 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: Baseline, After 45minutes of functional gait training (one-time experience)
Secondary outcomes (5)
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: Baseline, After 45minutes of functional gait training (one-time experience)
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: Baseline, After 45minutes of functional gait training (one-time experience)
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: Baseline, After 45minutes of functional gait training (one-time experience)
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: Baseline, After 45minutes of functional gait training (one-time experience)
User Satisfaction Questionnaire
We evaluate the satisfaction questionnaire for GEMS-H use.
Measured: After 45minutes of functional gait training (one-time experience)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start24 Nov 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders in Old AgeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106881
- Sponsor's protocol ID
- 2021-04-058
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
- ClinicalTrials.gov ID
- NCT05106881
- Acronym / sponsor ID
- 2021-04-058
- 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
- 225 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Nov 2021 (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 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.
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.
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
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged 40 to less than 85 years without a history of central nervous system disease
Key exclusion criteria (6 listed)
- 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
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: Baseline, After 45minutes of functional gait training (one-time experience)
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."
5 secondary outcomes
Change in Timed Up and Go test (TUG) from baseline in balance
Time frame: Baseline, After 45minutes of functional gait training (one-time experience)
Changes in Short Physical Performance Battery (SPPB) from baseline
Time frame: Baseline, After 45minutes of functional gait training (one-time experience)
Changes in Four Square Step Test (FSST) from baseline
Time frame: Baseline, After 45minutes of functional gait training (one-time experience)
Change in 6 minute walk test (6MWT) from Baseline
Time frame: Baseline, After 45minutes of functional gait training (one-time experience)
User Satisfaction Questionnaire
Time frame: After 45minutes of functional gait training (one-time experience)
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Samsung Medical Center 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 1 inclusion and 6 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: Baseline, After 45minutes of functional gait training (one-time experience)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.