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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389165
• Other study ID #: 2017-08-028
• Status: Completed
• Phase: N/A
• First received: December 26, 2017
• Last updated: December 26, 2017
• Start date: October 16, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Health Behavior

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour