FatigueHypershellNCT07840872
Exploring the Effect of the Hypershell Hip Exoskeleton on Fatiguing, Everyday Activities in Older Adults
A study testing Performance test and Hypershell assistance (EXO-ON Actuation) in people with Fatigue and Older Adults (65 Years and Older), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Older Adults (65 Years and Older), Exoskeleton Device
- What is being tested?
- Performance test and Hypershell assistance (EXO-ON Actuation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or older
- Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification
Who cannot join
- Physical injury or disorder that does not allow good physical performance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Swinnen contact
Belgium1 site
Brubotics Rehabilitation Research Center
Brussels, 1090
Eva Swinnen, Professor, +32-2-6292010, info@brubotics.eu
About this study
Official title: Exploring the Effect of a Hypershell Lower-limb Exoskeleton on Fatiguing, Everyday Activities
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?
Read more
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.
- Being tested
- Performance test, Hypershell assistance (EXO-ON Actuation)
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance testOther
Also called FATIG'AGE protocol
Participants 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)Device
Participants 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
| Study group | Role | What they receive |
|---|---|---|
| EXO-OFF → EXO-ON Actuation | Experimental | 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. Receives: Other: Performance test; Device: Hypershell assistance (EXO-ON Actuation) |
| EXO-ON Actuation → EXO-OFF | Experimental | 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. Receives: Other: Performance test; Device: Hypershell assistance (EXO-ON Actuation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During each experimental session, up to 60 minutes
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.
Measured: During each experimental session, up to 60 minutes
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.
Measured: During each experimental session, up to 60 minutes
Secondary outcomes (9)
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.
Measured: Immediately after each applicable experimental session
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.
Measured: Immediately after the Hypershell active-assistance experimental session
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.
Measured: Immediately after the Hypershell active-assistance experimental session
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 (%)
Measured: Continuously during each experimental session, up to 60 minutes
Heart Rate
Heart rate will be continuously recorded during the FATIG'AGE protocol using electrocardiography. Heart rate will be examined across the protocol and between experimental conditions. Unit of Measure: beats per minute (bpm)
Measured: Continuously during each experimental session, up to 60 minutes.
Respiratory Rate
Respiratory rate will be continuously recorded using an inductive plethysmography band during the FATIG'AGE protocol and examined across the protocol and between experimental conditions. Unit of Measure: breaths per minute
Measured: Continuously during each experimental session, up to 60 minutes.
Galvanic Skin Response
Galvanic skin response will be continuously recorded using finger electrodes during the FATIG'AGE protocol and examined across the protocol and between experimental conditions. Unit of Measure: microsiemens (µS).
Measured: Continuously during each experimental session, up to 60 minutes.
Lower-Limb Muscle Oxygen Saturation
Muscle oxygen saturation will be continuously recorded from selected lower-limb muscles (knee extensor, foot dorsi- and plantar flexor) using near-infrared spectroscopy sensors during the FATIG'AGE protocol and examined across the protocol and between experimental conditions. Unit of Measure: percent (%)
Measured: Continuously during each experimental session, up to 60 minutes.
Changes in Motion Data
Inertial Measurement Unit (IMU) data will be collected continuously throughout the FATIG'AGE protocol. The IMUs will record motion-related signals, including segment orientation, linear acceleration, and angular velocity. Data acquisition will explore changes in kinematics and gait parameters.
Measured: Continuously during each experimental session, up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Swinnen, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Prof, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840872
- Sponsor's protocol ID
- RevalExo_Hypershell
- Acronym
- Hypershell
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data (IPD) available to researchers outside the study team. Study data will be securely retained for planned in-house follow-up analyses and to protect participant privacy and confidentiality in accordance with applicable data protection requirements. Aggregate study results will be disseminated through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of a Hypershell Lower-limb Exoskeleton on Fatiguing, Everyday Activities
- ClinicalTrials.gov ID
- NCT07840872
- Acronym / sponsor ID
- Hypershell / RevalExo_Hypershell
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged 65 years or older
- Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification
Key exclusion criteria (1 listed)
- Physical injury or disorder that does not allow good physical performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance testAlso: FATIG'AGE protocolParticipants 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. | Other | EXO-OFF → EXO-ON Actuation, EXO-ON Actuation → EXO-OFF |
| Hypershell assistance (EXO-ON Actuation)Participants 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 | Device | EXO-OFF → EXO-ON Actuation, EXO-ON Actuation → EXO-OFF |
Primary outcome
Rate of Perceived Fatigue Progression
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Global Perceived Effect of the Hypershell
Time frame: Immediately after each applicable experimental session
Usability of the HyperShell Assessed With the System Usability Scale
Time frame: Immediately after the Hypershell active-assistance experimental session
User Experience With the Hypershell Assessed With the User Experience Questionnaire
Time frame: Immediately after the Hypershell active-assistance experimental session
Lower-Limb Muscle Activity
Time frame: Continuously during each experimental session, up to 60 minutes
Heart Rate
Time frame: Continuously during each experimental session, up to 60 minutes.
Respiratory Rate
Time frame: Continuously during each experimental session, up to 60 minutes.
Galvanic Skin Response
Time frame: Continuously during each experimental session, up to 60 minutes.
Lower-Limb Muscle Oxygen Saturation
Time frame: Continuously during each experimental session, up to 60 minutes.
Changes in Motion Data
Time frame: Continuously during each experimental session, up to 60 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data (IPD) available to researchers outside the study team. Study data will be securely retained for planned in-house follow-up analyses and to protect participant privacy and confidentiality in accordance with applicable data protection requirements. Aggregate study results will be disseminated through scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Swinnen contact
Eva Swinnen, Prof principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance test and Hypershell assistance (EXO-ON Actuation) in people with Fatigue and Older Adults (65 Years and Older), run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reinhard Claeys (02 477 44 89, reinhard.claeys@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Perceived Fatigue Progression (time frame: During each experimental session, up to 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.