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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13503
- CHA University
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Seated Control
Participants remained seated during the postprandial period without walking or wearable hip exoskeleton assistance.
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Comparatore attivo: Walking Without Bot-Fit
Participants performed walking without wearing the Bot-Fit wearable hip exoskeleton.
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Participants performed walking without wearing the Bot-Fit wearable hip exoskeleton during the postprandial period.
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Sperimentale: Bot-Fit Aqua Mode
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode.
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Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
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Sperimentale: Bot-Fit Boost Mode
Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode.
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Participants performed walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incremental Area Under the Curve for Postprandial Glucose
Lasso di tempo: Up to 120 minutes after meal ingestion during each experimental trial
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Incremental area under the curve for postprandial glucose was calculated during the postprandial measurement period for each experimental condition.
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Up to 120 minutes after meal ingestion during each experimental trial
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Peak Postprandial Glucose Concentration
Lasso di tempo: 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.
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Up to 120 minutes after meal ingestion during each experimental trial
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Heart Rate Response
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Seung-Bo Park, Ph.D, CHA University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BOTFIT-HA-2025
- S-2025-0600-000-1 (Altro numero di sovvenzione/finanziamento: Samsung Electronics)
- CHAMC 1044308-202503-BR-237-02 (Altro identificatore: CHA University Medical Center IRB approval number)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .