FatigueNCT07359573
The Effect of a Passive Hip Exoskeleton on Daily-life Fatigue in Older Adults
A study testing Performance test and Exoband in people with Fatigue and Older Adults (65 Years and Older), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
This crossover study investigates whether a passive lower-limb exoskeleton (Exoband) can reduce perceived exertion during everyday mobility tasks in older adults. Participants complete the fatigue protocol- a structured sequence of daily challenging tasks (e.g., overground walking, stair and slope walking, obstacle… 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)
- What is being tested?
- Performance test and Exoband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2025to Jun 2026
- 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
- > 65 years old
- Healthy physical condition
Who cannot join
- Physical injury or disorder that doesn't 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.
Belgium1 site
Brubotics Rehabilitation Research Center
Jette, Brussels Capital, 1090
About this study
Official title: Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
This crossover study investigates whether a passive lower-limb exoskeleton (Exoband) can reduce perceived exertion during everyday mobility tasks in older adults. Participants complete the fatigue protocol- a structured sequence of daily challenging tasks (e.g., overground walking, stair and slope walking, obstacle avoidance)-once with the Exoband and once without it, in randomized order and separated by a one-week washout period. During each session, distance covered until fatigue, rate of perceived exertion, physiological and gait parameters are recorded. The aim is to determine whether exoskeleton assistance enhances mobility performance and reduces functional fatigue across older adults.
- Conditions
- Fatigue, Older Adults (65 Years and Older)
- Being tested
- Performance test, Exoband
- 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
The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.
ExobandDevice
The participant will wear the Exoband (Moveo), which is a lightweight, soft wearable exoskeleton designed to assist walking by providing elastic support to the hip during gait. It uses passive elastic elements to store and release energy in sync with the user's movement, reducing muscular effort without motors or batteries. The system is unobtrusive and aims to support mobility while preserving natural movement patterns.
| Study group | Role | What they receive |
|---|---|---|
| Exoband ON | Active comparator | The participants execute the fatigue protocol while wearing the passive hip exoskeletons (Exoband). Receives: Other: Performance test; Device: Exoband |
| Exoband OFF | Placebo comparator | The participants execute the fatigue protocol without wearing the passive hip exoskeletons (Exoband). Receives: Other: Performance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Ratings of Perceived Exertion throughout the protocol execution
The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion, using the modified Borg Scale (score ranging from 0 'no exertion' to 10 'maximal exertion'). This will be expressed verbally by the participant throughout the execution of the protocol.
Measured: Through study completion, an average of 1-2 weeks.
Secondary outcomes (6)
Changes in muscle activity (surface EMG) throughout the protocol execution
Muscle activity data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Changes in heart rate (variability) (ECG sensors) throughout the protocol execution
Cardiorespiratory data (Heart rate) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Changes in muscle oxygen saturation (Moxy Monitor) throughout the protocol execution
Oxygen saturation data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Changes in electrodermal activity (Galvanic Skin Response - finger electrodes) throughout the protocol execution
Electrodermal activity data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Changes in motion data (IMU sensors) throughout the protocol execution
Inertial Measurement Unit (IMU) data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Changes in respiratory rate (respiratory chest band) throughout the protocol execution
Respiratory data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Through study completion, an average of 1-2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start11 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Beckwee, Vrije Universiteit Brussel
- Investigators
- David Beckwée, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359573
- Sponsor's protocol ID
- RevalExo_Exoband
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
- ClinicalTrials.gov ID
- NCT07359573
- Acronym / sponsor ID
- RevalExo_Exoband
- Conditions
- Fatigue, Older Adults (65 Years and Older)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jan 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.
This crossover study investigates whether a passive lower-limb exoskeleton (Exoband) can reduce perceived exertion during everyday mobility tasks in older adults. Participants complete the fatigue protocol- a structured sequence of daily challenging tasks (e.g., overground walking, stair and slope walking, obstacle avoidance)-once with the Exoband and once without it, in randomized order and separated by a one-week washout period. During each session, distance covered until fatigue, rate of perceived exertion, physiological and gait parameters are recorded. The aim is to determine whether exoskeleton assistance enhances mobility performance and reduces functional fatigue across older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exoband ON | Active comparator | Other: Performance test, Device: ExobandThe participants execute the fatigue protocol while wearing the passive hip exoskeletons (Exoband). |
| Exoband OFF | Placebo comparator | Other: Performance testThe participants execute the fatigue protocol without wearing the passive hip exoskeletons (Exoband). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- > 65 years old
- Healthy physical condition
Key exclusion criteria (1 listed)
- Physical injury or disorder that doesn't 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 testThe participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected. | Other | Exoband OFF, Exoband ON |
| ExobandThe participant will wear the Exoband (Moveo), which is a lightweight, soft wearable exoskeleton designed to assist walking by providing elastic support to the hip during gait. It uses passive elastic elements to store and release energy in sync with the user's movement, reducing muscular effort without motors or batteries. The system is unobtrusive and aims to support mobility while preserving natural movement patterns. | Device | Exoband ON |
Primary outcome
Changes in the Ratings of Perceived Exertion throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion, using the modified Borg Scale (score ranging from 0 'no exertion' to 10 'maximal exertion'). This will be expressed verbally by the participant throughout the execution of the protocol.
6 secondary outcomes
Changes in muscle activity (surface EMG) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
Changes in heart rate (variability) (ECG sensors) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
Changes in muscle oxygen saturation (Moxy Monitor) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
Changes in electrodermal activity (Galvanic Skin Response - finger electrodes) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
Changes in motion data (IMU sensors) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
Changes in respiratory rate (respiratory chest band) throughout the protocol execution
Time frame: Through study completion, an average of 1-2 weeks.
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 22 Jan 2026.
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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.
David Beckwée, PhD 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 Exoband 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: enrolling by invitation, as of the sponsor's last update on 22 Jan 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Ratings of Perceived Exertion throughout the protocol execution (time frame: Through study completion, an average of 1-2 weeks.). 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 22 Jan 2026.