Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 1
Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
The purpose of this research study is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
研究概览
详细说明
Study 1 is a randomized, controlled, two-period crossover trial. The study evaluates We Innovate Mobility (WIM)-assisted treadmill walking in community-dwelling adults aged ≥65 years who are at risk for mobility disability. WIM is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. The WIM device will be set to Air mode at Assistance Level 1 to standardize the degree of robotic assistance across participants and sessions while allowing exercise dose to be manipulated through treadmill speed, grade, and duration.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kim Kennedy
- 电话号码：336.713.8567
- 邮箱：kimberly.kennedy@advocatehealth.org
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Atrium Health Wake Forest Baptist
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Community-dwelling adult aged ≥65 years
- Able to safely wear and use the WIM device
- Willing to complete conventional and WIM-assisted treadmill walking
- Able to provide informed consent and comply with study procedures
- Usual gait speed of 0.6-0.8 m/s
Exclusion Criteria:
- Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
- Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
- Willing to complete conventional and WIM-assisted treadmill walking
- Requires a cane, walker, or other assistive device for ambulation
- Regular participation in structured aerobic exercise
- Any condition judged by the study clinician to make participation unsafe or interfere with study procedures
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
|---|---|
|
实验性的：We Innovate Mobility (WIM)-Assisted Treadmill Walking
participants will complete one WIM-assisted treadmill-walking session |
We Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill while wearing the device. |
|
有源比较器：Conventional Treadmill Walking
participants will complete one conventional treadmill-walking session |
Participants will walk on the treadmill without assistance from the WIM device. |
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 |
|---|---|---|
|
Exercise Dose
大体时间：Day 1
|
Exercise dose is defined as walking duration × average treadmill speed × average treadmill grade. |
Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Perceived Exertion
大体时间：Day 1
|
Rate of Perceived Exertion scale is 6-20 with the higher the number indicating a higher level of exertion. |
Day 1
|
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Number of Participants that Ended Walking Session
大体时间：Day 1
|
Number of participants that wanted to stop walking sessions due to symptoms such as shortness of breath, leg fatigue, dizziness, balance difficulties, pain, etc. |
Day 1
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
WIM Walking Experience Survey
大体时间：Day 1
|
We Innovate Mobility (WIM) Walking Experience survey has a total score range of 8-40 with higher score indicating a more comfortable experience with the device. |
Day 1
|
合作者和调查者
调查人员
- 首席研究员：Bumsoo Ahn, PhD、Atrium Health Wake Forest Baptist
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB00157231
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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