StrokeNCT06513377
Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
A study testing Performance test in people with Stroke and Sarcopenia, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Sarcopenia, Fatigue
- What is being tested?
- Performance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- ≥ 3 months ago stroke diagnosis
- FAC levels 3-5
- > 65 years old
- Grip strength: < 27 kg (man) or < 16 kg (woman)
- Be mobile independently
- > 18 years old
- Healthy physical and medical condition
Who cannot join
- Severe problems with speech or memory which prevents the participant to understand or follow instruction
- Co-morbidities that could influence the task execution and collected data
- Older adults with sarcopenia:
- Severe problems with speech or memory which prevents the participant to understand or follow instruction
- Co-morbidities that could influence the task execution and collected data
- Healthy individuals:
- Physical injury or disorder that doesn't allow good physical performance
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Brubotics Rehabilitation Research Center
Jette, Brussels Capital, 1090
About this study
Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.
The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.
Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.
- Conditions
- Stroke, Sarcopenia, Fatigue
- Being tested
- Performance test
- Medical subject headings
- Stroke, Sarcopenia, 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.
| Study group | Role | What they receive |
|---|---|---|
| People post-stroke | Experimental | The intervention includes a stress test that induces progressive feelings of fatigue. Receives: Other: Performance test |
| Older adults with sarcopenia | Experimental | The intervention includes a stress test that induces progressive feelings of fatigue. Receives: Other: Performance test |
| Healthy individuals | Experimental | The intervention includes a stress test that induces progressive feelings of fatigue. 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. This will be expressed verbally by the participant throughout the execution of the protocol.
Measured: Collected during all measurement moments (2-12 weeks).
Secondary outcomes (10)
Changes in muscle activity throughout the protocol execution
Muscle activity data (EMG) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in heart rate (variability) 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: Collected during all measurement moments (2-12 weeks).
Changes in oxygen saturation throughout the protocol execution
Oxygen saturation data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in electrodermal activity throughout the protocol execution
Electrodermal activity data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in muscle force myography throughout the protocol execution
Muscle force myography data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in skin temperature throughout the protocol execution
Skin temperature data (degrees Celsius) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in motion data throughout the protocol execution
IMU data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in plantar pressure throughout the protocol execution
Plantar pressure distribution data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in gaze patter throughout the protocol execution
Eye tracking data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Changes in joint angles throughout the protocol execution
Kinematic data (degrees) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.
Measured: Collected during all measurement moments (2-12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Mar 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Beckwee, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513377
- Sponsor's protocol ID
- RevalExo2
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2024
- Last updated
- 23 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 23 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
- NCT06513377
- Acronym / sponsor ID
- RevalExo2
- Conditions
- Stroke, Sarcopenia, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 22 Jul 2024 (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.
Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.
The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.
Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People post-stroke | Experimental | Other: Performance testThe intervention includes a stress test that induces progressive feelings of fatigue. |
| Older adults with sarcopenia | Experimental | Other: Performance testThe intervention includes a stress test that induces progressive feelings of fatigue. |
| Healthy individuals | Experimental | Other: Performance testThe intervention includes a stress test that induces progressive feelings of fatigue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years old
- ≥ 3 months ago stroke diagnosis
- FAC levels 3-5
- > 65 years old
- Grip strength: < 27 kg (man) or < 16 kg (woman)
Key exclusion criteria (7 listed)
- Severe problems with speech or memory which prevents the participant to understand or follow instruction
- Co-morbidities that could influence the task execution and collected data
- Severe problems with speech or memory which prevents the participant to understand or follow instruction
- Co-morbidities that could influence the task execution and collected data
- 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 | Healthy individuals, Older adults with sarcopenia, People post-stroke |
Primary outcome
Changes in the Ratings of Perceived Exertion throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion. This will be expressed verbally by the participant throughout the execution of the protocol.
10 secondary outcomes
Changes in muscle activity throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in heart rate (variability) throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in oxygen saturation throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in electrodermal activity throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in muscle force myography throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in skin temperature throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in motion data throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in plantar pressure throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in gaze patter throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Changes in joint angles throughout the protocol execution
Time frame: Collected during all measurement moments (2-12 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Stroke and Sarcopenia, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 23 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Collected during all measurement moments (2-12 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 23 Jan 2026.