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Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes (Bot-Fit T2D St)

5. juli 2026 opdateret af: CHA University

Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes: A Randomized Crossover Proof-of-Concept Study

This randomized crossover proof-of-concept study evaluated the effects of walking with a wearable hip exoskeleton on postprandial glycemic and physiological responses in patients with type 2 diabetes. Participants completed four experimental conditions: 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. The primary aim was to determine whether walking with the wearable hip exoskeleton alters postprandial glucose responses compared with seated control and conventional walking conditions in patients with type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study investigated whether walking with a wearable hip exoskeleton could modulate postprandial glycemic and physiological responses in patients with type 2 diabetes. 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 and perceived exertion, 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 patients with type 2 diabetes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13503
        • CHA University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults diagnosed with type 2 diabetes mellitus.
  • 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 unstable cardiovascular, neurological, or musculoskeletal conditions that could affect walking ability or safe participation.
  • Participants with conditions that could interfere with postprandial glucose assessment.
  • Participants who were unable to safely use the wearable hip exoskeleton.
  • Participants who were unable to comply with the study procedures.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Aktiv komparator: Non-Assisted Walking
Participants performed 30 minutes of overground walking without wearing the Bot-Fit device.
Adfærdsmæssigt: Non-Assisted Walking
Participants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period.
Eksperimentel: Bot-Fit Aqua Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode.
Enhed: Bot-Fit Aqua Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
Eksperimentel: Bot-Fit Boost Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode.
Enhed: Bot-Fit Boost Mode
Participants performed 30 minutes of overground 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
Tidsramme
Peak Postprandial Glucose Concentration
Tidsramme: Up to 120 minutes after meal ingestion during each experimental trial
Up to 120 minutes after meal ingestion during each experimental trial
Heart Rate Response
Tidsramme: Up to 30 minutes
Up to 30 minutes
Rating of Perceived Exertion
Tidsramme: Up to 30 minutes
Up to 30 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CHA University

Samarbejdspartnere

Samsung Electronics

Efterforskere

  • Ledende efterforsker: Seung-Bo Park, Ph.D, CHA University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. marts 2026

Primær færdiggørelse (Faktiske)

24. maj 2026

Studieafslutning (Faktiske)

24. maj 2026

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

5. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BOTFIT-T2D-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)?

JA

IPD-planbeskrivelse

Deidentified individual participant data underlying the main results of the study may be shared upon reasonable request. The shared data may include postprandial glucose responses, heart rate, blood lactate, rating of perceived exertion, and relevant demographic and physiological variables after deidentification.

IPD-delingstidsramme

Data may be made available beginning 6 months after publication of the main study results and for up to 3 years thereafter.

IPD-delingsadgangskriterier

Data may be shared with qualified researchers who submit a reasonable research proposal to the corresponding author. Access will be granted only after review and approval by the investigators and, where required, appropriate institutional or ethics committee approval. Data will be shared only for scientific purposes and in a deidentified form.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes mellitus (T2DM)

Kliniske forsøg med Non-Assisted Walking

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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