Exploring the Effect of a Hypershell Lower-limb Exoskeleton on Fatiguing, Everyday Activities
| Registry | NCT07840872, acronym Hypershell |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, supportive care |
| Enrollment | 20 (Estimated) |
| Sponsor | Vrije Universiteit Brussel (Other) |
| Conditions | Fatigue, Older Adults (65 Years and Older), Exoskeleton Device |
| Interventions | Performance test, Hypershell assistance (EXO-ON Actuation) (Other, device) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-09-25, last updated 2026-09-25 |
| Locations | 1 site in Belgium |
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All trials for Fatigue All trials for Older Adults (65 Years and Older) All trials of Performance test All trials of Hypershell assistance (EXO-ON Actuation)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| EXO-OFF → EXO-ON Actuation | Experimental | Other: Performance test; Device: Hypershell assistance (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. |
| EXO-ON Actuation → EXO-OFF | Experimental | Other: Performance test; Device: Hypershell assistance (EXO-ON Actuation) | 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. |
Sex: All, ages: 65 Years to any, accepts healthy volunteers
Inclusion Criteria: * Aged 65 years or older * Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification Exclusion Criteria: * Physical injury or disorder that does not allow good physical performance
| Facility | City | Country | Status |
|---|---|---|---|
| Brubotics Rehabilitation Research Center | Brussels | Belgium |