Exploring the Effect of the Hypershell Hip Exoskeleton on Fatiguing, Everyday Activities in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVrije Universiteit Brussel
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 65 years or older
Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification
Disqualifiers
Physical injury or disorder that does not allow good physical performance
Trial design
Design model
Crossover
Treatments tested in this trial
Performance test
Other interventionParticipants will perform the FATIG'AGE multi-task functional mobility protocol. The protocol includes a fixed sequence of daily activities such as walking, sit-to-stand transitions, stair ascent and descent, slope walking, walking on uneven surfaces, carrying an object, and dual-task walking.
Hypershell assistance (EXO-ON Actuation)
DeviceParticipants wear the Hypershell hip exoskeleton with active assistance. In the active-assistance condition, the device uses motion sensors to detect the user's movements and provides powered assistance to support hip movement during functional mobility tasks
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: EXO-OFF → EXO-ON ActuationExperimental treatment 2 interventions
Group B: EXO-ON Actuation → EXO-OFFExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of Perceived Fatigue Progression
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.
Time frame
During each experimental session, up to 60 minutes2
Protocol Duration Until Termination
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.
Time frame
During each experimental session, up to 60 minutes3
Number of Executed Tasks Until Protocol Termination
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.
Time frame
During each experimental session, up to 60 minutesSecondary outcomes
1
Global Perceived Effect of the Hypershell
Participants will rate the perceived effect of wearing the HyperShell on their physical performance using the Global Perceived Effect (GPE) scale. The GPE is a 7-point Likert scale ranging from perceived deterioration to perceived improvement. The questionnaire will be administered following the HyperShell transparent and active-assistance conditions.
Time frame
Immediately after each applicable experimental session2
Usability of the HyperShell Assessed With the System Usability Scale
Usability of the Hypershell will be assessed using the 10-item System Usability Scale (SUS). Items are rated on a 5-point Likert scale and transformed into a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
Time frame
Immediately after the Hypershell active-assistance experimental session3
User Experience With the Hypershell Assessed With the User Experience Questionnaire
User experience with the Hypershell will be assessed using the 26-item User Experience Questionnaire (UEQ). The questionnaire assesses six dimensions: attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty. Items are scored on a semantic differential scale ranging from -3 to +3, with higher scores indicating a more positive user experience.
Time frame
Immediately after the Hypershell active-assistance experimental session4
Lower-Limb Muscle Activity
Surface electromyography will be continuously recorded from selected lower-limb muscles (knee extensor, foot dorsi- and plantar flexor) during the FATIG'AGE protocol. Muscle activation amplitude and frequency will be derived from the EMG signal and compared between experimental conditions. Unit of Measure: percent of reference contraction (%)
Time frame
Continuously during each experimental session, up to 60 minutesSponsors and contacts
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Source ClinicalTrials.gov
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