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

NCT07692802 | Completed

• 3 other identifiers: BOTFIT-T2D-2025S-2025-0600-000-1CHAMC 1044308-202503-BR-237-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Wearable hip exoskeleton; Bot-Fit; Type 2 diabetes; Postprandial glucose; Glycemic response; Walking

Outcome Measures

Primary Outcomes (1)

• Incremental Area Under the Curve for Postprandial Glucose

  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

Secondary Outcomes (3)

• Peak Postprandial Glucose Concentration

  Up to 120 minutes after meal ingestion during each experimental trial

• Heart Rate Response

  Up to 30 minutes

• Rating of Perceived Exertion

  Up to 30 minutes

Study Arms (3)

Non-Assisted Walking

ACTIVE COMPARATOR

Participants performed 30 minutes of overground walking without wearing the Bot-Fit device.

Behavioral: Non-Assisted Walking

Bot-Fit Aqua Mode

EXPERIMENTAL

Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode.

Device: Bot-Fit Aqua Mode

Bot-Fit Boost Mode

EXPERIMENTAL

Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode.

Device: Bot-Fit Boost Mode

Interventions

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 Aqua Mode

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.

Bot-Fit Boost Mode

Non-Assisted Walking BEHAVIORAL

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

Non-Assisted Walking

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHA University: lead
• Samsung Electronics: collaborator

Study Sites (1)

CHA University

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seung-Bo Park, Ph.D

  CHA University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The outcomes assessor was masked to the intervention condition during outcome processing and analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant completed four experimental conditions in a randomized crossover design: 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.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 9, 2026
• Study Start: March 2, 2026
• Primary Completion: May 24, 2026
• Study Completion: May 24, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data may be made available beginning 6 months after publication of the main study results and for up to 3 years thereafter.
• Access Criteria: 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.

Locations

KR (1)