ClinicalTrials.gg
CompletedNCT03389165Updated Jan 3, 2018

The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults

An interventional study of Wearable hip assist robot in Gait, Unsteady and Health Behavior, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years to 84 Years. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
65 Years to 84 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Gait Disorders, Neurologic with a site in Korea, Republic of — 3 open to participants now, 4 under way, none of them phase 3. Gait Disorders, Neurologic · Korea, Republic of.

Enrollment
10th of 15
15 · median 22
Started
2017
with 2 others
No phase
14 of 15
2 open now
Registered
5th of 15
by date
Lead sponsor
5 of 15
Samsung Medical Center

Among the 15 studies in Gait Disorders, Neurologic with a site in Korea, Republic of, this one is the 10th largest by enrollment, is one of 3 that started in 2017, is one of 14 with no phase, and was the 5th registered.

Gait Disorders, Neurologic

346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.

Browse Gait Disorders, Neurologic studies →

Open to participants now

3 of the 15 studies in Gait Disorders, Neurologic with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 36 Gait Disorders, Neurologic studies recruiting now, 14 (39%) set no upper age limit and 19 (53%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.

This study: 65 Years to 84 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Gait, Unsteady
  • Health Behavior

Keywords

  • Wearable hip assist robot
  • Elderly adult
  • Metabolic energy expenditure
  • Stair ascent
04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elderly adults who absence of a history of musculoskeletal or central nervous system diseases
  • High levels of physical performance (SPPB > 8)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Elderly adults

    Stair climbing with and without a wearable hip assist robot

    Device: Wearable hip assist robot

Interventions

  • DeviceWearable hip assist robot

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Nov 2017, 0 months.

Of 184 non-industry interventional studies with no phase under Gait Disorders, Neurologic, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 0 months is below that.

Counting every sponsor, half of 197 studies reached it within 14 months; a quarter within 5 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2017
First posted
Jan 3, 2018
StartActual
Oct 16, 2017
Primary completionActual
Nov 10, 2017
CompletionActual
Nov 10, 2017
Last update
Jan 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03389165
Responsible party
Yun-Hee Kim (Professor, MD, PhD, Samsung Medical Center) — Principal investigator
First posted
Jan 3, 2018
Start date
Oct 16, 2017
Primary completion
Nov 10, 2017
Completion
Nov 10, 2017
Last update
Jan 3, 2018

Study contacts

Yun-Hee Kim, MD, PhD
study chair · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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