GaitNCT03484624
Effect of Wearable Hip-Assist Robot on Reduction of Cardiopulmonary Metabolic Efficiency in Healthy Adults
A study testing Treadmill walking in people with Gait, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait
- What is being tested?
- Treadmill walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Apr 2018to 31 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly adults over age 65
- Those without a history of central nervous system disease
Who cannot join
- Those who have problems with walking due to problems such as visual field defects or fractures
- A person whose height is less than 140 cm or not more than 185 cm
- Body mass index BMI (body mass index) based on 35 or more obese
- Those with a cognitive problem that are difficult to understand and participate fully in this study
- Those who are at risk of falling when walking with serious dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Wearable Hip-Assist Robot on Reduction of Muscle Fatigue and Cardiopulmonary Metabolic Efficiency in Elderly Adults: A Preliminary Study
The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).
Read the detailed description
The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).
Metabolic energy expenditure and muscle fatigue are measured simultaneously.
- Conditions
- Gait
- Being tested
- Treadmill walking
- Keywords
- Muscle; Fatigue, Wearable hip assist robot, Metabolic energy expenditure
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill walkingDevice
All subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS)
| Study group | Role | What they receive |
|---|---|---|
| Treadmill walking | Experimental | All subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS) Receives: Device: Treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on metabolic energy expenditure
All subjects underwent measurements of respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS).
Metabolic energy expenditure and muscle fatigue are measured simultaneously
Measured: 1 hour
Secondary outcomes (1)
Change on muscle fatigue
All subjects underwent measurements of muscle fatigue at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS).
Metabolic energy expenditure and muscle fatigue are measured simultaneously
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 posted2 Apr 2018
- Study start2 Apr 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484624
- Sponsor's protocol ID
- 2018-02-064
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wearable Hip-Assist Robot on Reduction of Muscle Fatigue and Cardiopulmonary Metabolic Efficiency in Elderly Adults: A Preliminary Study
- ClinicalTrials.gov ID
- NCT03484624
- Acronym / sponsor ID
- 2018-02-064
- Conditions
- Gait
- Keywords
- Muscle; Fatigue, Wearable hip assist robot, Metabolic energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 2 Apr 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 purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).
Detailed description
The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).
Metabolic energy expenditure and muscle fatigue are measured simultaneously.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treadmill walking | Experimental | Device: Treadmill walkingAll subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Elderly adults over age 65
- Those without a history of central nervous system disease
Key exclusion criteria (5 listed)
- Those who have problems with walking due to problems such as visual field defects or fractures
- A person whose height is less than 140 cm or not more than 185 cm
- Body mass index BMI (body mass index) based on 35 or more obese
- Those with a cognitive problem that are difficult to understand and participate fully in this study
- Those who are at risk of falling when walking with serious dizziness
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 |
|---|---|---|
| Treadmill walkingAll subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS) | Device | Treadmill walking |
Primary outcome
Change on metabolic energy expenditure
Time frame: 1 hour
All subjects underwent measurements of respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS). Metabolic energy expenditure and muscle fatigue are measured simultaneously
1 secondary outcome
Change on muscle fatigue
Time frame: 1 hour
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 4 Nov 2019.
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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 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 Treadmill walking in people with Gait, 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 5 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 4 Nov 2019. 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 (time frame: 1 hour). 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 4 Nov 2019.