Exploring the Effect of a Hypershell Lower-limb Exoskeleton on Fatiguing, Everyday Activities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Perceived Fatigue Progression
研究概览
简要总结
The goal of this clinical trial is to learn how wearing the Hypershell lower-limb exoskeleton affects perceived fatigue during everyday mobility activities in adults aged 65 years and older. The main questions it aims to answer are:
- Does active assistance from the Hypershell reduce the development of perceived fatigue during repeated everyday mobility tasks?
- Does wearing the Hypershell affect how long participants can perform the protocol and how many tasks they can complete before reaching a high level of fatigue?
- How do participants perceive the usability, comfort, and overall experience of using the Hypershell?
- What are the biomechanical and physiological responses from wearing the Hypershell?
Researchers will compare two conditions: performing the mobility protocol without the Hypershell and wearing the Hypershell with active assistance.
Participants will:
- Attend one baseline session including questionnaires, physical tests, and familiarization with the Hypershell and study procedures.
- Attend two experimental sessions in a randomized order, with at least one week between sessions.
- Complete a laboratory-based mobility protocol including daily activities such as standing up from a chair, walking, stair climbing, slope walking, walking on uneven surfaces, carrying an object, and performing a cognitive task while walking.
- Report their perceived fatigue throughout the protocol using the Borg CR10 scale.
- Wear non-invasive sensors that measure physiological responses and movement during the experimental sessions.
- Provide feedback about their experience using the HyperShell.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years or older
- •Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification
排除标准
- •Physical injury or disorder that does not allow good physical performance
研究组 & 干预措施
EXO-OFF → EXO-ON Actuation
Participants complete the FATIG'AGE protocol under two conditions in the following order: without wearing the Hypershell and wearing the Hypershell with active assistance. Experimental sessions are separated by a washout period of at least one week.
干预措施: Performance test (Other)
EXO-OFF → EXO-ON Actuation
Participants complete the FATIG'AGE protocol under two conditions in the following order: without wearing the Hypershell and wearing the Hypershell with active assistance. Experimental sessions are separated by a washout period of at least one week.
干预措施: Hypershell assistance (EXO-ON Actuation) (Device)
EXO-ON Actuation → EXO-OFF
Participants complete the FATIG'AGE protocol under two conditions in the following order: wearing the Hypershell with active assistance and without wearing the Hypershell. Experimental sessions are separated by a washout period of at least one week.
干预措施: Performance test (Other)
EXO-ON Actuation → EXO-OFF
Participants complete the FATIG'AGE protocol under two conditions in the following order: wearing the Hypershell with active assistance and without wearing the Hypershell. Experimental sessions are separated by a washout period of at least one week.
干预措施: Hypershell assistance (EXO-ON Actuation) (Device)
结局指标
主要结局
Rate of Perceived Fatigue Progression
时间窗: During each experimental session, up to 60 minutes
Rating of Perceived Fatigue (RPF) will be assessed verbally using the Borg Category-Ratio 10 (CR10) scale after each task of the FATIG'AGE protocol. The Borg CR10 ranges from 0 (no exertion) to 10 (maximal exertion). The rate of increase in RPE across consecutive task executions will be determined for each experimental condition, with a lower rate indicating a slower development of perceived exertion.
Protocol Duration Until Termination
时间窗: During each experimental session, up to 60 minutes
Total time, in minutes, that the participant performs the FATIG'AGE protocol before reaching a predefined termination criterion: Borg CR10 greater or equal to two consecutive score of 8, or the maximum protocol duration of 60 minutes. Longer duration indicates that the participant was able to perform the protocol for longer before termination.
Number of Executed Tasks Until Protocol Termination
时间窗: During each experimental session, up to 60 minutes
Total number of individual FATIG'AGE task executions completed before reaching a predefined termination criterion: Borg CR10 equal or greater to two consecutive scores of 8, or the maximum protocol duration of 60 minutes. A higher number indicates that more functional mobility tasks were completed before protocol termination.
次要结局
- Global Perceived Effect of the Hypershell(Immediately after each applicable experimental session)
- Usability of the HyperShell Assessed With the System Usability Scale(Immediately after the Hypershell active-assistance experimental session)
- User Experience With the Hypershell Assessed With the User Experience Questionnaire(Immediately after the Hypershell active-assistance experimental session)
- Lower-Limb Muscle Activity(Continuously during each experimental session, up to 60 minutes)
- Heart Rate(Continuously during each experimental session, up to 60 minutes.)
- Respiratory Rate(Continuously during each experimental session, up to 60 minutes.)
- Galvanic Skin Response(Continuously during each experimental session, up to 60 minutes.)
- Lower-Limb Muscle Oxygen Saturation(Continuously during each experimental session, up to 60 minutes.)
- Changes in Motion Data(Continuously during each experimental session, up to 60 minutes.)
研究者
Eva Swinnen
Professor
Vrije Universiteit Brussel