- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695441
Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Healthy Adults (Bot-Fit Health)
Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Healthy Adults: A Randomized Crossover Proof-of-Concept Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigated whether walking with a wearable hip exoskeleton could modulate postprandial glycemic and physiological responses in healthy adults. Using a randomized crossover design, each participant completed four experimental conditions in a controlled laboratory setting: seated control, walking without the wearable hip exoskeleton, walking with the Bot-Fit device in Aqua mode, and walking with the Bot-Fit device in Boost mode.
Postprandial glucose responses were assessed after meal ingestion during each experimental trial. Physiological responses, including heart rate, perceived exertion, and energy expenditure, were also evaluated to compare the metabolic and perceptual demands of walking with and without the wearable hip exoskeleton. The study was designed as a proof-of-concept trial to examine whether wearable hip exoskeleton-assisted walking may influence postprandial glucose regulation in healthy adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, South Korea, 13503
- CHA University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged 20 to 65 years.
- Participants who were able to complete walking trials with and without the wearable hip exoskeleton.
- Participants who provided written informed consent before participation.
Exclusion Criteria:
- Participants with diagnosed metabolic, cardiovascular, neurological, or musculoskeletal disorders.
- Participants with conditions that could affect walking ability or safe use of the wearable hip exoskeleton.
- Participants taking medications known to affect glucose metabolism.
- Participants who were unable to comply with the study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Seated Control
Participants remained seated during the postprandial period without walking or wearable hip exoskeleton assistance.
|
|
|
Active Comparator: Walking Without Bot-Fit
Participants performed walking without wearing the Bot-Fit wearable hip exoskeleton.
|
Participants performed walking without wearing the Bot-Fit wearable hip exoskeleton during the postprandial period.
|
|
Experimental: Bot-Fit Aqua Mode
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode.
|
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
|
|
Experimental: Bot-Fit Boost Mode
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode.
|
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental Area Under the Curve for Postprandial Glucose
Time Frame: Up to 120 minutes after meal ingestion during each experimental trial
|
Incremental area under the curve for postprandial glucose was calculated during the postprandial measurement period for each experimental condition.
|
Up to 120 minutes after meal ingestion during each experimental trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Postprandial Glucose Concentration
Time Frame: Up to 120 minutes after meal ingestion during each experimental trial
|
The peak glucose concentration observed during the postprandial measurement period was compared across experimental conditions.
|
Up to 120 minutes after meal ingestion during each experimental trial
|
|
Heart Rate Response
Time Frame: From the start to the end of the 30-minute intervention or control period on each experimental trial day
|
Heart rate was assessed during each experimental condition to evaluate physiological responses to walking with and without the wearable hip exoskeleton.
|
From the start to the end of the 30-minute intervention or control period on each experimental trial day
|
|
Rating of Perceived Exertion
Time Frame: Immediately after each experimental condition
|
Rating of perceived exertion was assessed to compare subjective exercise intensity across walking conditions.
|
Immediately after each experimental condition
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Seung-Bo Park, Ph.D, CHA University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOTFIT-HA-2025
- S-2025-0600-000-1 (Other Grant/Funding Number: Samsung Electronics)
- CHAMC 1044308-202503-BR-237-02 (Other Identifier: CHA University Medical Center IRB approval number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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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