- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13503
- CHA University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Seated Control
Participants remained seated during the postprandial period without walking or wearable hip exoskeleton assistance.
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|
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Aktiv komparator: 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.
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Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incremental Area Under the Curve for Postprandial Glucose
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak Postprandial Glucose Concentration
Tidsramme: Up to 120 minutes after meal ingestion during each experimental trial
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The peak glucose concentration observed during the postprandial measurement period was compared across experimental conditions.
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Up to 120 minutes after meal ingestion during each experimental trial
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|
Heart Rate Response
Tidsramme: From the start to the end of the 30-minute intervention or control period on each experimental trial day
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Heart rate was assessed during each experimental condition to evaluate physiological responses to walking with and without the wearable hip exoskeleton.
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From the start to the end of the 30-minute intervention or control period on each experimental trial day
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Rating of Perceived Exertion
Tidsramme: Immediately after each experimental condition
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Rating of perceived exertion was assessed to compare subjective exercise intensity across walking conditions.
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Immediately after each experimental condition
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Seung-Bo Park, Ph.D, CHA University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BOTFIT-HA-2025
- S-2025-0600-000-1 (Andet bevillings-/finansieringsnummer: Samsung Electronics)
- CHAMC 1044308-202503-BR-237-02 (Anden identifikator: CHA University Medical Center IRB approval number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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