Effect of Soft Robotic Exosuit Assistance in Healthy People

January 12, 2023 updated by: Yonsei University
This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Deog Young Kim
  • Phone Number: 82-2-2228-3714
  • Email: KIMDY@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
          • Deog Young Kim
          • Phone Number: 82-2-2228-3714
          • Email: KIMDY@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past
  • Those who have no problem wearing knee and hip assist robots
  • A person who understands this research, has a willingness to participate voluntarily, and agrees to participate

Exclusion Criteria

- researcher judges that participation in this research is inappropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy person
Device: EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation

- After filling out the consent form for 10 subjects who meet the selection criteria, a total of three evaluations are conducted: one pre-evaluation and one post-evaluation for the knee assist robot and hip assist robot.

Pre-evaluation: Evaluation simultaneously with walking on an inclined treadmill (Uphill_incline 10°) for 5 minutes without wearing knee and hip assist robots (speed 1.5 m/s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen consumption measured
Time Frame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks

① Primary evaluation variable

- The difference between the amount of oxygen consumption measured before wearing the robot and the amount of oxygen consumption measured before and after wearing the robot [O2 rate = VO2 (ml/min) / kg of body weight, O2 cost = rate / walking speed (m/ min)].
Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D Motion Capture
Time Frame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
3D Motion Capture
Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 30, 2023

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2022-1220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Available upon request

IPD Sharing Time Frame

Available upon request

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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