NCT03389165

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

25 days

First QC Date

December 26, 2017

Last Update Submit

December 26, 2017

Conditions

Keywords

Wearable hip assist robotElderly adultMetabolic energy expenditureStair ascent

Outcome Measures

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.

    1 hour

Study Arms (1)

Elderly adults

EXPERIMENTAL

Stair climbing with and without a wearable hip assist robot

Device: Wearable hip assist robot

Interventions

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).

Elderly adults

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gait Disorders, NeurologicHealth Behavior

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 3, 2018

Study Start

October 16, 2017

Primary Completion

November 10, 2017

Study Completion

November 10, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations