Healthy PersonNCT05693233
Effect of Soft Robotic Exosuit Assistance in Healthy People
A study testing EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation in people with Healthy Person, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Person
- What is being tested?
- EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2023to 31 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past
- Those who have no problem wearing knee and hip assist robots
- A person who understands this research, has a willingness to participate voluntarily, and agrees to participate
Who cannot join
- researcher judges that participation in this research is inappropriate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Deog Young Kim, 82-2-2228-3714, KIMDY@yuhs.ac
About this study
This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.
- Conditions
- Healthy Person
- Being tested
- EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluationDevice
- After filling out the consent form for 10 subjects who meet the selection criteria, a total of three evaluations are conducted: one pre-evaluation and one post-evaluation for the knee assist robot and hip assist robot.
Pre-evaluation: Evaluation simultaneously with walking on an inclined treadmill (Uphill_incline 10°) for 5 minutes without wearing knee and hip assist robots (speed 1.5 m/s).
| Study group | Role | What they receive |
|---|---|---|
| Healthy person | Experimental | Healthy person Receives: Device: EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption measured
① Primary evaluation variable
- The difference between the amount of oxygen consumption measured before wearing the robot and the amount of oxygen consumption measured before and after wearing the robot [O2 rate = VO2 (ml/min) / kg of body weight, O2 cost = rate / walking speed (m/ min)].
Measured: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
Secondary outcomes (1)
3D Motion Capture
3D Motion Capture
Measured: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start30 Jan 2023 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693233
- Sponsor's protocol ID
- 4-2022-1220
- Status last verified
- Jan 2023
- First submitted
- 23 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Robotic Exosuit Assistance in Healthy People
- ClinicalTrials.gov ID
- NCT05693233
- Acronym / sponsor ID
- 4-2022-1220
- Conditions
- Healthy Person
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy person | Experimental | Device: EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluationHealthy person |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past
- Those who have no problem wearing knee and hip assist robots
- A person who understands this research, has a willingness to participate voluntarily, and agrees to participate
Key exclusion criteria (1 listed)
- researcher judges that participation in this research is inappropriate
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 |
|---|---|---|
| EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation- After filling out the consent form for 10 subjects who meet the selection criteria, a total of three evaluations are conducted: one pre-evaluation and one post-evaluation for the knee assist robot and hip assist robot. Pre-evaluation: Evaluation simultaneously with walking on an inclined treadmill (Uphill_incline 10°) for 5 minutes without wearing knee and hip assist robots (speed 1.5 m/s). | Device | Healthy person |
Primary outcome
oxygen consumption measured
Time frame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
① Primary evaluation variable - The difference between the amount of oxygen consumption measured before wearing the robot and the amount of oxygen consumption measured before and after wearing the robot [O2 rate = VO2 (ml/min) / kg of body weight, O2 cost = rate / walking speed (m/ min)].
1 secondary outcome
3D Motion Capture
Time frame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Yes. Available upon request
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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.
Deog Young Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation in people with Healthy Person, run by Yonsei University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deog Young Kim (82-2-2228-3714, KIMDY@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen consumption measured (time frame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks). 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 20 Jan 2023.