Effect of Soft Robotic Exosuit Assistance in Healthy People

NCT05693233 | Unknown

• 1 other identifier: 4-2022-1220
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Person

Outcome Measures

Primary Outcomes (1)

• oxygen consumption measured

  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 Outcomes (1)

• 3D Motion Capture

  Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks

Study Arms (1)

Healthy person

EXPERIMENTAL

Healthy person

Device: EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation

Interventions

EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation DEVICE

\- 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).

Healthy person

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- researcher judges that participation in this research is inappropriate

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Deog Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

82-2-2228-3714; KIMDY@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 20, 2023
• Study Start: January 30, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available upon request

Locations

KR (1)