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Completed

NCT Number: NCT07692802

Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA University

Seongnam-si, Gyeonggi-do, 13503, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bot-Fit Aqua Mode

Device

Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.

Bot-Fit Boost Mode

Device

Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.

Non-Assisted Walking

Behavioral

Participants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Peak Postprandial Glucose Concentration

    Time frame: Up to 120 minutes after meal ingestion during each experimental trial

  2. Heart Rate Response

    Time frame: Up to 30 minutes

  3. Rating of Perceived Exertion

    Time frame: Up to 30 minutes

Sponsors and collaborators

Lead sponsor

CHA University

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

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

Acronym: Bot-Fit T2D St

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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