Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes (Bot-Fit T2D St)
2026年7月5日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
14
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Gyeonggi-do
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Seongnam-si、Gyeonggi-do、韩国、13503
- CHA University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
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实验性的：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.
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实验性的：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incremental Area Under the Curve for Postprandial Glucose
大体时间：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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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Peak Postprandial Glucose Concentration
大体时间：Up to 120 minutes after meal ingestion during each experimental trial
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Up to 120 minutes after meal ingestion during each experimental trial
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Heart Rate Response
大体时间：Up to 30 minutes
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Up to 30 minutes
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Rating of Perceived Exertion
大体时间：Up to 30 minutes
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Up to 30 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月2日
初级完成 (实际的)
2026年5月24日
研究完成 (实际的)
2026年5月24日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月5日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月5日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- BOTFIT-T2D-2025
- S-2025-0600-000-1 (其他赠款/资助编号：Samsung Electronics)
- CHAMC 1044308-202503-BR-237-02 (其他标识符：CHA University Medical Center IRB approval number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
Data may be made available beginning 6 months after publication of the main study results and for up to 3 years thereafter.
IPD 共享访问标准
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.