- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389165
The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Elderly adults
Stair climbing with and without a wearable hip assist robot
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition
Time Frame: 1 hour
|
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.
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1 hour
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-08-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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