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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Sydkorea, 13503
- CHA University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Non-Assisted Walking
Participants performed 30 minutes of overground walking without wearing the Bot-Fit device.
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Participants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period.
|
|
Experimentell: Bot-Fit Aqua Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode.
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Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
|
|
Experimentell: Bot-Fit Boost Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode.
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Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incremental Area Under the Curve for Postprandial Glucose
Tidsram: 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.
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Up to 120 minutes after meal ingestion during each experimental trial
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Peak Postprandial Glucose Concentration
Tidsram: 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
Tidsram: Up to 30 minutes
|
Up to 30 minutes
|
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Rating of Perceived Exertion
Tidsram: Up to 30 minutes
|
Up to 30 minutes
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Seung-Bo Park, Ph.D, CHA University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 mars 2026
Primärt slutförande (Faktisk)
24 maj 2026
Avslutad studie (Faktisk)
24 maj 2026
Studieregistreringsdatum
Först inskickad
5 juli 2026
Först inskickad som uppfyllde QC-kriterierna
5 juli 2026
Första postat (Faktisk)
9 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BOTFIT-T2D-2025
- S-2025-0600-000-1 (Annat bidrag/finansieringsnummer: Samsung Electronics)
- CHAMC 1044308-202503-BR-237-02 (Annan identifierare: CHA University Medical Center IRB approval number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data may be made available beginning 6 months after publication of the main study results and for up to 3 years thereafter.
Kriterier för IPD Sharing Access
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.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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