Gait, UnsteadyNCT03389165
The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
A study testing Wearable hip assist robot in people with Gait, Unsteady and Health Behavior, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study was to identify the assistance effect of the new wearable hip assist robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy expenditure of elderly adults with and… Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Gait, Unsteady, Health Behavior
- What is being tested?
- Wearable hip assist robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2017to 10 Nov 2017
- 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 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly adults who absence of a history of musculoskeletal or central nervous system diseases
- High levels of physical performance (SPPB > 8)
Who cannot join
- Elderly adults who absence of the ability to walk independently due to visual field defects, fractures, or severe muscle weakness
- Severe dizziness that might lead to falls
- Cognitive disorders that might be difficult to understand accurately in this study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to identify the assistance effect of the new wearable hip assist robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy expenditure of elderly adults with and without the GEMS.
Read the detailed description
Primary objective of this study is to demonstrate the effect of a wearable hip assist robot on cardiopulmonary metabolic efficiency during stair ascent in elderly adults.
Fifteen elderly adults participated in this study. The stair ascent trials were designed to climb stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea. The metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy) while participants performed randomly assigned two different conditions consecutively:, free ascent without the GEMS (NoGEMS) or robot-assisted ascent with the GEMS (GEMS). Participants rested for 10 minutes between the two trial conditions.
- Conditions
- Gait, Unsteady, Health Behavior
- Being tested
- Wearable hip assist robot
- Keywords
- Wearable hip assist robot, Elderly adult, Metabolic energy expenditure, Stair ascent
- Medical subject headings
- Gait Disorders, Neurologic, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable hip assist robotDevice
All participants climbed stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea with and without a wearable hip assist robot. During climbing stairs, the metabolic energy expenditure of all participants was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
| Study group | Role | What they receive |
|---|---|---|
| Elderly adults | Experimental | Stair climbing with and without a wearable hip assist robot Receives: Device: Wearable hip assist robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition
All participants stood in a comfortable position for 5 minutes to obtain baseline variables before stair ascent. Participants were then asked to climb stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea, in a step-over-step manner under two different conditions, GEMS and NoGEMS. The GEMS and NoGEMS conditions were conducted in a random order, and just before the second condition, participants stood for 2～3 minutes to obtain baseline variables once more.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start16 Oct 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
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, UnsteadyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Investigators
- Yun-Hee Kim, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389165
- Sponsor's protocol ID
- 2017-08-028
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DS, Lee HJ, Lee SH, Chang WH, Jang J, Choi BO, Ryu GH, Kim YH. A wearable hip-assist robot reduces the cardiopulmonary metabolic energy expenditure during stair ascent in elderly adults: a pilot cross-sectional study. BMC Geriatr. 2018 Sep 29;18(1):230. doi: 10.1186/s12877-018-0921-1.
PubMed 30268096
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
- ClinicalTrials.gov ID
- NCT03389165
- Acronym / sponsor ID
- 2017-08-028
- Conditions
- Gait, Unsteady, Health Behavior
- Keywords
- Wearable hip assist robot, Elderly adult, Metabolic energy expenditure, Stair ascent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 3 Jan 2018 (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 aim of this study was to identify the assistance effect of the new wearable hip assist robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy expenditure of elderly adults with and without the GEMS.
Detailed description
Primary objective of this study is to demonstrate the effect of a wearable hip assist robot on cardiopulmonary metabolic efficiency during stair ascent in elderly adults.
Fifteen elderly adults participated in this study. The stair ascent trials were designed to climb stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea. The metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy) while participants performed randomly assigned two different conditions consecutively:, free ascent without the GEMS (NoGEMS) or robot-assisted ascent with the GEMS (GEMS). Participants rested for 10 minutes between the two trial conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly adults | Experimental | Device: Wearable hip assist robotStair climbing with and without a wearable hip assist robot |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Elderly adults who absence of a history of musculoskeletal or central nervous system diseases
- High levels of physical performance (SPPB > 8)
Key exclusion criteria (3 listed)
- Elderly adults who absence of the ability to walk independently due to visual field defects, fractures, or severe muscle weakness
- Severe dizziness that might lead to falls
- Cognitive disorders that might be difficult to understand accurately in this study
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 |
|---|---|---|
| Wearable hip assist robotAll participants climbed stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea with and without a wearable hip assist robot. During climbing stairs, the metabolic energy expenditure of all participants was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy). | Device | Elderly adults |
Primary outcome
Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition
Time frame: 1 hour
All participants stood in a comfortable position for 5 minutes to obtain baseline variables before stair ascent. Participants were then asked to climb stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea, in a step-over-step manner under two different conditions, GEMS and NoGEMS. The GEMS and NoGEMS conditions were conducted in a random order, and just before the second condition, participants stood for 2～3 minutes to obtain baseline variables once more.
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 3 Jan 2018.
- Derived from this study: PubMed 30268096Kim DS, Lee HJ, Lee SH, Chang WH, Jang J, Choi BO, Ryu GH, Kim YH. A wearable hip-assist robot reduces the cardiopulmonary metabolic energy expenditure during stair ascent in elderly adults: a pilot cross-sectional study. BMC Geriatr. 2018 Sep 29;18(1):230. doi: 10.1186/s12877-018-0921-1.
- Individual participant dataSharing planned: No
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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.
Yun-Hee Kim, MD, PhD study chair
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 Wearable hip assist robot in people with Gait, Unsteady and Health Behavior, 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 2 inclusion and 3 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 3 Jan 2018. 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 on metabolic energy expenditure in GEMS condition compared with NoGEMS condition (time frame: 1 hour). 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 NCT03389165, 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 3 Jan 2018.