- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594938
Studying Fatigue and Movement After Stroke
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:
- 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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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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.
|
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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.
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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.
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Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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Outcome measure will be recorded throughout the fatiguing contractions in the single experimental session (up to 40 minutes) and compared over 4 fatigue phases.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMF_STROKE_FWO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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