Mental FatigueNCT07650903
Mental Fatigue Effects on Posture and Spinal Reflexes
A study testing Mental Fatigue Induction in people with Mental Fatigue, run by Izmir Bakircay University at 1 site in Belgium.
Trial summary
This randomized crossover study investigates the effects of mental fatigue on postural control and spinal reflex excitability in healthy physically active adults aged 18-35 years. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue
- What is being tested?
- Mental Fatigue Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2026to 1 Dec 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged between 18 and 35 years
- Recreational active
Who cannot join
- Previous major lower limb injury (last 6 months)
- Present neurological or musculoskeletal disorders
- Involvement in another concurrent physical or cognitive intervention study
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
Vrije Universiteit Brussel
Brussels, Pleinlaan 2, 1050
Sidney Grosprêtre, PhD, +32 (0)2 629 22 22, sidney.grospretre@univ-fcomte.fr
About this study
Official title: Effects of Mental Fatigue on Posture and Spinal Reflexes Modulations
This randomized crossover study investigates the effects of mental fatigue on postural control and spinal reflex excitability in healthy physically active adults aged 18-35 years. Participants will complete two experimental conditions: a mentally fatiguing Stroop task and a control condition involving passive documentary watching, separated by at least 48 hours. Postural control will be assessed using force plate measures of center of pressure displacement during bipedal and unipedal stance, with and without concurrent cognitive dual-tasking. In parallel, spinal reflex excitability will be evaluated using H-reflex recordings from the triceps surae muscles across sitting and standing postures.
The primary aim is to determine whether mental fatigue increases postural sway, particularly in more challenging balance conditions such as single-leg stance. The secondary aim is to examine whether mental fatigue alters the normal modulation of spinal reflex excitability across progressively demanding postural tasks. Additional biomechanical and neuromuscular measures, including EMG activity and hip kinematics, will be recorded to provide insight into underlying control mechanisms.
The study will include approximately 26 participants, with each serving as their own control. Data will contribute to understanding how cognitive fatigue influences balance control and spinal-level neuromuscular regulation.
- Conditions
- Mental Fatigue
- Being tested
- Mental Fatigue Induction, Control Condition
- Keywords
- Postural control, Center of pressure, Spinal reflex excitability, H-reflex, Stroop task, Electromyography
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Fatigue InductionBehavioural
Participants complete a 60-minute computerized Stroop color-word task designed to induce mental fatigue. The task consists of repeated incongruent stimuli requiring rapid and accurate responses, with difficulty individualized based on a prior maximal Stroop performance test. Performance (reaction time and accuracy) is continuously recorded. Subjective mental fatigue is assessed intermittently during the task using a visual analogue scale.
Control ConditionBehavioural
Participants watch a 60-minute neutral documentary of their choice. This condition is designed to match the mental fatigue intervention in duration and general sensory engagement without inducing cognitive fatigue. No cognitive task performance is required. Subjective mental fatigue is assessed at equivalent time points using a visual analogue scale.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Experimental | Participants watch a 60-minute neutral documentary of their choice. This condition is designed to control for time, visual input, and arousal without inducing mental fatigue. Postural control and spinal reflex excitability are assessed immediately before and after the task. Receives: Behavioral: Control Condition |
| Mental Fatigue Condition | Experimental | Participants complete a 60-minute computerized Stroop task designed to induce mental fatigue. The task involves continuous performance of color-word interference trials adjusted to individual capacity. Postural control and spinal reflex excitability are assessed immediately before and after the task. Receives: Behavioral: Mental Fatigue Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure (CoP) Displacement (Postural Sway)
Postural sway will be assessed using center of pressure (CoP) displacement area and oscillation parameters measured during bipedal and unipedal stance on a force plate. Higher values indicate greater postural instability. Comparisons will be made between mental fatigue and control conditions, pre- and post-intervention.
Measured: Pre-intervention and immediately post-intervention (each experimental session)
Subjective Mental Fatigue
Subjective mental fatigue will be assessed using a visual analog scale (VAS) ranging from 0 (no fatigue) to 100 (extreme fatigue).
Measured: During intervention (every 15 minutes) and immediately post-intervention
Secondary outcomes (3)
Spinal Reflex Excitability (H-reflex Modulation)
Spinal reflex excitability will be assessed using H-reflex amplitude (H50 and Hmax), normalized to maximal M-wave (Mmax), recorded from the triceps surae muscles (soleus, medial gastrocnemius, lateral gastrocnemius) during sitting, bipedal stance, and unipedal stance. Changes will be compared between mental fatigue and control conditions.
Measured: Pre-intervention and immediately post-intervention across sitting, bipedal stance, and unipedal stance conditions
Surface Electromyography (EMG) Activity of Postural Muscles
Muscle activation will be assessed using root mean square (RMS) electromyography (EMG) activity recorded from the soleus, medial gastrocnemius, lateral gastrocnemius, tibialis anterior, vastus medialis, and multifidus muscles, normalized to maximal M-wave (MMAX).
Measured: Continuous recording during postural tasks, pre-intervention and immediately post-intervention (each condition)
Hip / Leg Movement (IMU Angular Velocity)
Hip and leg movements will be assessed using inertial measurement unit (IMU) sensors placed at the proximal femoral epicondyle. Outcome is the resultant angular velocity across movement axes during postural tasks.
Measured: Pre-intervention and immediately post-intervention during bipedal and unipedal stance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design in which each participant completes both a mental fatigue condition and a control condition in counterbalanced order, separated by a washout period of at least 48 hours. Participants serve as their own control, and outcomes are measured pre- and post-intervention under identical testing conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, University of Franche-Comté
- Responsible party
- Principal investigator, Gürsu Sayar, Izmir Bakircay University
- Investigators
- Bart Roelands, Professor, Study director, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650903
- Sponsor's protocol ID
- MFspinal
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Due to the sensitive nature of physiological and health-related data and GDPR restrictions, data access will be limited to the study investigators. De-identified aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Fatigue on Posture and Spinal Reflexes Modulations
- ClinicalTrials.gov ID
- NCT07650903
- Acronym / sponsor ID
- MFspinal
- Conditions
- Mental Fatigue
- Keywords
- Postural control, Center of pressure, Spinal reflex excitability, H-reflex, Stroop task, Electromyography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, University of Franche-Comté
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jun 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 randomized crossover study investigates the effects of mental fatigue on postural control and spinal reflex excitability in healthy physically active adults aged 18-35 years. Participants will complete two experimental conditions: a mentally fatiguing Stroop task and a control condition involving passive documentary watching, separated by at least 48 hours. Postural control will be assessed using force plate measures of center of pressure displacement during bipedal and unipedal stance, with and without concurrent cognitive dual-tasking. In parallel, spinal reflex excitability will be evaluated using H-reflex recordings from the triceps surae muscles across sitting and standing postures.
The primary aim is to determine whether mental fatigue increases postural sway, particularly in more challenging balance conditions such as single-leg stance. The secondary aim is to examine whether mental fatigue alters the normal modulation of spinal reflex excitability across progressively demanding postural tasks. Additional biomechanical and neuromuscular measures, including EMG activity and hip kinematics, will be recorded to provide insight into underlying control mechanisms.
The study will include approximately 26 participants, with each serving as their own control. Data will contribute to understanding how cognitive fatigue influences balance control and spinal-level neuromuscular regulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized crossover design in which each participant completes both a mental fatigue condition and a control condition in counterbalanced order, separated by a washout period of at least 48 hours. Participants serve as their own control, and outcomes are measured pre- and post-intervention under identical testing conditions.
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Experimental | Behavioral: Control ConditionParticipants watch a 60-minute neutral documentary of their choice. This condition is designed to control for time, visual input, and arousal without inducing mental fatigue. Postural control and spinal reflex excitability are assessed immediately before and after the task. |
| Mental Fatigue Condition | Experimental | Behavioral: Mental Fatigue InductionParticipants complete a 60-minute computerized Stroop task designed to induce mental fatigue. The task involves continuous performance of color-word interference trials adjusted to individual capacity. Postural control and spinal reflex excitability are assessed immediately before and after the task. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants aged between 18 and 35 years
- Recreational active
Key exclusion criteria (3 listed)
- Previous major lower limb injury (last 6 months)
- Present neurological or musculoskeletal disorders
- Involvement in another concurrent physical or cognitive intervention study
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 |
|---|---|---|
| Mental Fatigue InductionParticipants complete a 60-minute computerized Stroop color-word task designed to induce mental fatigue. The task consists of repeated incongruent stimuli requiring rapid and accurate responses, with difficulty individualized based on a prior maximal Stroop performance test. Performance (reaction time and accuracy) is continuously recorded. Subjective mental fatigue is assessed intermittently during the task using a visual analogue scale. | Behavioural | Mental Fatigue Condition |
| Control ConditionParticipants watch a 60-minute neutral documentary of their choice. This condition is designed to match the mental fatigue intervention in duration and general sensory engagement without inducing cognitive fatigue. No cognitive task performance is required. Subjective mental fatigue is assessed at equivalent time points using a visual analogue scale. | Behavioural | Control Condition |
Primary outcome
Center of Pressure (CoP) Displacement (Postural Sway)
Time frame: Pre-intervention and immediately post-intervention (each experimental session)
Postural sway will be assessed using center of pressure (CoP) displacement area and oscillation parameters measured during bipedal and unipedal stance on a force plate. Higher values indicate greater postural instability. Comparisons will be made between mental fatigue and control conditions, pre- and post-intervention.
Subjective Mental Fatigue
Time frame: During intervention (every 15 minutes) and immediately post-intervention
Subjective mental fatigue will be assessed using a visual analog scale (VAS) ranging from 0 (no fatigue) to 100 (extreme fatigue).
3 secondary outcomes
Spinal Reflex Excitability (H-reflex Modulation)
Time frame: Pre-intervention and immediately post-intervention across sitting, bipedal stance, and unipedal stance conditions
Surface Electromyography (EMG) Activity of Postural Muscles
Time frame: Continuous recording during postural tasks, pre-intervention and immediately post-intervention (each condition)
Hip / Leg Movement (IMU Angular Velocity)
Time frame: Pre-intervention and immediately post-intervention during bipedal and unipedal stance
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 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Due to the sensitive nature of physiological and health-related data and GDPR restrictions, data access will be limited to the study investigators. De-identified aggregated results will be reported in publications.
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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.
Bart Roelands, Professor study director
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 Mental Fatigue Induction in people with Mental Fatigue, run by Izmir Bakircay University 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 3 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 16 Jun 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 Sidney Grosprêtre, PhD (+32 (0)2 629 22 22, sidney.grospretre@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Pressure (CoP) Displacement (Postural Sway) (time frame: Pre-intervention and immediately post-intervention (each experimental session)). 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 16 Jun 2026.