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

Primary Purpose

Gait, Unsteady, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Wearable hip assist robot
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gait, Unsteady focused on measuring Wearable hip assist robot, Elderly adult, Metabolic energy expenditure, Stair ascent

Eligibility Criteria

65 Years - 84 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly adults

Arm Description

Stair climbing with and without a wearable hip assist robot

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2017
Last Updated
December 26, 2017
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03389165
Brief Title
The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Official Title
The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Health Behavior
Keywords
Wearable hip assist robot, Elderly adult, Metabolic energy expenditure, Stair ascent

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly adults
Arm Type
Experimental
Arm Description
Stair climbing with and without a wearable hip assist robot
Intervention Type
Device
Intervention Name(s)
Wearable hip assist robot
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30268096
Citation
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.
Results Reference
derived

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

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