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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03389165

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gait, Unsteady Health Behavior	Device: Wearable hip assist robot	N/A

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

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 16, 2017

Actual Primary Completion Date :

Nov 10, 2017

Actual Study Completion Date :

Nov 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elderly adults Stair climbing with and without a wearable hip assist robot	Device: Wearable 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).

Arm

Intervention/Treatment

Experimental: Elderly adults

Stair climbing with and without a wearable hip assist robot

Device: Wearable 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).

Outcome Measures

Primary Outcome Measures

Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

Study Chair: Yun-Hee Kim, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03389165

Other Study ID Numbers:

2017-08-028

First Posted:

Jan 3, 2018

Last Update Posted:

Jan 3, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center

Wearable hip assist robot

Elderly adult

Metabolic energy expenditure

Stair ascent

Additional relevant MeSH terms:

Gait Disorders, Neurologic

Study Results

No Results Posted as of Jan 3, 2018