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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incremental Area Under the Curve for Postprandial Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The outcomes assessor was masked to the intervention condition during outcome processing and analysis.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incremental Area Under the Curve for Postprandial Glucose
时间窗: 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.
次要结局
- Rating of Perceived Exertion(Up to 30 minutes)
- Heart Rate Response(Up to 30 minutes)
- Peak Postprandial Glucose Concentration(Up to 120 minutes after meal ingestion during each experimental trial)