Effect of Soft Robotic Exosuit Assistance in Healthy People

Healthy Person Clinical Trial

Official title:

Effect of Soft Robotic Exosuit Assistance in Healthy People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693233
• Other study ID #: 4-2022-1220
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2023
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: 82-2-2228-3714
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Person

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen consumption measured	? 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	3D Motion Capture	3D Motion Capture	Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks