StrokeNCT07594938
Studying Fatigue and Movement After Stroke
An observational study of Stroke and Cerebro-vascular Accident, run by Vrije Universiteit Brussel.
Trial summary
The goal of this observational study is to learn how neuromuscular fatigue develops after stroke and how changes in brain activity, muscle activity, and their interaction contribute to reduced motor performance in stroke survivors compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebro-vascular Accident, Ischemia Stroke
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Oct 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Healthy, age-matched controls will be recruited through our research group's network and residential care homes in Belgium.
Who may be able to join
- Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included.
Who cannot join
- Exclusion criteria include a history of a previous stroke, severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps/hamstrings), other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. Athletes are defined as individuals who participated in organized competitive sports and engaged in structured training ≥3 sessions per week for ≥1 year within the 5 years preceding stroke. Control participants will be excluded if they meet the same exclusion criteria.
About this study
Official title: Exploring Neuromuscular Fatigue in Stroke Survivors: Understanding Central-Peripheral Interaction
The goal of this observational study is to learn how neuromuscular fatigue develops after stroke and how changes in brain activity, muscle activity, and their interaction contribute to reduced motor performance in stroke survivors compared to healthy individuals. The study will include adults with a first-ever stroke in the subacute phase and age-matched healthy volunteers.
The main questions it aims to answer are:
Read more
- How does neuromuscular fatigue develop during repeated muscle contractions after stroke compared to healthy individuals?
- How do brain activity, muscle activity, and brain-muscle interaction change during fatigue after stroke?
Researchers will compare stroke participants and healthy control participants to determine whether fatigue-related changes are more strongly associated with altered brain activity, altered muscle activity, or disrupted brain-muscle communication after stroke.
Participants will:
- Perform repeated leg muscle contractions until fatigue while seated in an experimental setup
- Wear non-invasive sensors to record brain activity (EEG) and muscle activity (EMG) during the task
- Complete the study during a single experimental session in which fatigue-related changes will be measured throughout the task
Read the detailed description
Stroke is a leading cause of long-term disability worldwide. Although many stroke survivors can initiate movement, sustaining motor performance during everyday activities often becomes progressively difficult, suggesting abnormal development of neuromuscular fatigue. Neuromuscular fatigue, defined as an exercise-induced reduction in force-generating capacity, arises through interactions between central neural and peripheral muscular mechanisms. However, despite extensive investigation in healthy populations, the neurophysiological mechanisms underlying neuromuscular fatigue after stroke remain poorly understood. Existing studies have focused predominantly on peripheral manifestations of fatigue, with limited investigation of cortical oscillatory dynamics and brain-muscle communication. Here, we propose a multimodal neurophysiological study combining electroencephalography (EEG), electromyography (EMG), and corticomuscular coherence analyses to determine whether fatigability after stroke is driven predominantly by altered central neural processes rather than peripheral muscle failure. Stroke survivors and age-matched healthy controls will perform sustained isometric contractions while neural and muscular activity are recorded across progressive fatigue stages. We hypothesize that stroke survivors will exhibit earlier and greater fatigability, accompanied by altered cortical oscillatory activity, peripheral muscular changes, and disrupted corticomuscular coherence, consistent with a predominant contribution of central oscillatory dysfunction.
- Conditions
- Stroke, Cerebro-vascular Accident, Ischemia Stroke, Hemorrhage Stroke
- Keywords
- fatigue, electroencephalography, EEG, electromyography, EMG, stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subacute stroke | Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include a history of a previous stroke, severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps/hamstrings), other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. | |
| Healthy participants | Healthy age-matched controls ≥18 years and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative spectral power and ERD/ERS magnitude
Fatigue-related changes in sensorimotor cortical activity will be assessed using EEG-derived absolute and relative spectral power in the mu (8-12 Hz), beta (13-30/35 Hz), and gamma (30/35-100 Hz) frequency bands, as well as changes in event-related desynchronization/event-related synchronization (ERD/ERS) magnitude over time. Measurements will be obtained at pre-fatigue baseline and continuously during the fatiguing task, with data segmented into contraction epochs and grouped into four fatigue phases for analysis.
Measured: Outcome measure will be recorded at baseline and throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
EMG median frequency
Peripheral manifestations of fatigue will be assessed using shifts in EMG median frequency during repeated contractions. Data will be recorded continuously during the task and analyzed across contraction epochs grouped into four fatigue phases.
Measured: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
Secondary outcomes (1)
Corticomuscular coherence
The interaction between cortical and muscular activity will be assessed using CMC, which quantifies synchronization between EEG and EMG signals. Corticomuscular coherence will be assessed from simultaneous EEG and EMG recordings during repeated contractions and analyzed across contraction epochs grouped into four fatigue phases.
Measured: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594938
- Sponsor's protocol ID
- NMF_STROKE_FWO
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Neuromuscular Fatigue in Stroke Survivors: Understanding Central-Peripheral Interaction
- ClinicalTrials.gov ID
- NCT07594938
- Acronym / sponsor ID
- NMF_STROKE_FWO
- Conditions
- Stroke, Cerebro-vascular Accident, Ischemia Stroke, Hemorrhage Stroke
- Keywords
- fatigue, electroencephalography, EEG, electromyography, EMG, stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 19 May 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 observational study is to learn how neuromuscular fatigue develops after stroke and how changes in brain activity, muscle activity, and their interaction contribute to reduced motor performance in stroke survivors compared to healthy individuals. The study will include adults with a first-ever stroke in the subacute phase and age-matched healthy volunteers.
The main questions it aims to answer are:
- How does neuromuscular fatigue develop during repeated muscle contractions after stroke compared to healthy individuals?
- How do brain activity, muscle activity, and brain-muscle interaction change during fatigue after stroke?
Researchers will compare stroke participants and healthy control participants to determine whether fatigue-related changes are more strongly associated with altered brain activity, altered muscle activity, or disrupted brain-muscle communication after stroke.
Participants will:
- Perform repeated leg muscle contractions until fatigue while seated in an experimental setup
- Wear non-invasive sensors to record brain activity (EEG) and muscle activity (EMG) during the task
- Complete the study during a single experimental session in which fatigue-related changes will be measured throughout the task
Detailed description
Stroke is a leading cause of long-term disability worldwide. Although many stroke survivors can initiate movement, sustaining motor performance during everyday activities often becomes progressively difficult, suggesting abnormal development of neuromuscular fatigue. Neuromuscular fatigue, defined as an exercise-induced reduction in force-generating capacity, arises through interactions between central neural and peripheral muscular mechanisms. However, despite extensive investigation in healthy populations, the neurophysiological mechanisms underlying neuromuscular fatigue after stroke remain poorly understood. Existing studies have focused predominantly on peripheral manifestations of fatigue, with limited investigation of cortical oscillatory dynamics and brain-muscle communication. Here, we propose a multimodal neurophysiological study combining electroencephalography (EEG), electromyography (EMG), and corticomuscular coherence analyses to determine whether fatigability after stroke is driven predominantly by altered central neural processes rather than peripheral muscle failure. Stroke survivors and age-matched healthy controls will perform sustained isometric contractions while neural and muscular activity are recorded across progressive fatigue stages. We hypothesize that stroke survivors will exhibit earlier and greater fatigability, accompanied by altered cortical oscillatory activity, peripheral muscular changes, and disrupted corticomuscular coherence, consistent with a predominant contribution of central oscillatory dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subacute stroke | – | –Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include a history of a previous stroke, severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps/hamstrings), other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. |
| Healthy participants | – | –Healthy age-matched controls ≥18 years and Montreal Cognitive Assessment (MoCA) ≥21 will be included. Exclusion criteria include other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Healthy, age-matched controls will be recruited through our research group's network and residential care homes in Belgium.
Key inclusion criteria (1 listed)
- Stroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3/5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included.
Key exclusion criteria (1 listed)
- Exclusion criteria include a history of a previous stroke, severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps/hamstrings), other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. Athletes are defined as individuals who participated in organized competitive sports and engaged in structured training ≥3 sessions per week for ≥1 year within the 5 years preceding stroke. Control participants will be excluded if they meet the same exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute and relative spectral power and ERD/ERS magnitude
Time frame: Outcome measure will be recorded at baseline and throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
Fatigue-related changes in sensorimotor cortical activity will be assessed using EEG-derived absolute and relative spectral power in the mu (8-12 Hz), beta (13-30/35 Hz), and gamma (30/35-100 Hz) frequency bands, as well as changes in event-related desynchronization/event-related synchronization (ERD/ERS) magnitude over time. Measurements will be obtained at pre-fatigue baseline and continuously during the fatiguing task, with data segmented into contraction epochs and grouped into four fatigue phases for analysis.
EMG median frequency
Time frame: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
Peripheral manifestations of fatigue will be assessed using shifts in EMG median frequency during repeated contractions. Data will be recorded continuously during the task and analyzed across contraction epochs grouped into four fatigue phases.
1 secondary outcome
Corticomuscular coherence
Time frame: Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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 19 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebro-vascular Accident, run by Vrije Universiteit Brussel.
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 1 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Absolute and relative spectral power and ERD/ERS magnitude (time frame: Outcome measure will be recorded at baseline and throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.). The study lists 2 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 19 May 2026.