Mental FatigueNCT07710755
Effects of Cognitive Fatigue on Gait
A study testing Mental fatigue in people with Mental Fatigue, run by State University of New York at Buffalo.
Trial summary
The goal of this study is to comprehend how mental fatigue could affect human gait. The main questions to answer are: Does mental fatigue change how people walk? How long does it take for walking patterns to return to normal after mental fatigue sets in? What role do constructs like boredom, sleepiness, and motivation… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue
- What is being tested?
- Mental fatigue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Neurotypical individuals with no self-reported history of neurological or cognitive disorders.
- Able to walk independently, without an assistive device.
- Fluent in English.
- Recruitment will aim for gender balance across the sample.
- For Day 2, participants must arrive with clean, dry hair, free of styling products (e.g., gels, oils), to ensure adequate EEG electrode contact.
Who cannot join
- Outside the age range of 18-60 years.
- Self-reported history of neurological or cognitive disorders (e.g., epilepsy, multiple sclerosis, stroke/traumatic brain injury).
- Any musculoskeletal condition or injury affecting normal gait.
- Use of an assistive device for walking (e.g., cane, walker, brace).
- Self-reported photosensitive epilepsy or seizure disorder triggered by screen/visual stimuli.
- Non-English speaking.
- Day 2 restrictions: less than 6 hours of sleep the night before; caffeine within 2 hours of the session; alcohol within 24 hours of the session.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to comprehend how mental fatigue could affect human gait. The main questions to answer are:
- Does mental fatigue change how people walk?
- How long does it take for walking patterns to return to normal after mental fatigue sets in?
- What role do constructs like boredom, sleepiness, and motivation play in this relationship?
Read more
To achieve this, participants will take part in the experiment, split into two sessions:
Day 1 (online, about 25 minutes): Practice session. Participants will practice a computer task that will be used to induce mental fatigue in the next session.
Day 2 (in-person, about 1.5 to 2 hours): Participants will wear several wearable sensors: motion sensors on their legs, feet, and back, sensor insoles in their shoes, a cap that measures brain activity, and glasses that track eye movement. After sensor placement, participants will walk in a straight line for 10 meters to measure their normal walking pattern. They will then complete a 32-minute computer task designed to induce mental fatigue. Afterward, participants will walk in a straight line for 10 meters again, rest for 3 minutes, and repeat this walk-and-rest cycle 3 more times. Participants will also answer short questions about how tired, bored, and alert they feel throughout the session.
Read the detailed description
Background:
Most prior research on mental fatigue and gait has examined concurrent dual-task walking, in which a cognitive task and walking occur simultaneously. It remains unclear whether gait is altered following (rather than during) a mentally fatiguing task. This study addresses that gap using TloadDback, an adaptive N-back paradigm (Borragán et al., 2016) that individually calibrates cognitive demand to maintain consistent task difficulty across participants, as the mental fatigue induction method.
Design:
This is a within-subject, repeated-measures design. All primary analyses will be conducted on data collected during the in-person session. Sample size (up to 30 enrolled, target N = 24) was determined via a power analysis using pilot data (N = 5; within-subject design, α = 0.05, power = 0.90).
Mental Fatigue Induction Task:
TloadDback is administered as a single continuous 32-minute block. Participants view a continuous sequence of number-letter-number stimuli and respond via keypress (odd/even number), when seeing a number, or spacebar (letter repeat), when seeing a letter. Stimulus-presentation speed is individually calibrated during the practice session to the maximum speed at which the participant maintains greater than 85% accuracy, ensuring standardized cognitive demand across participants during the main session.
Sensor:
Inertial measurement units (IMUs): 8 units, placed at the shanks (2), thighs (2), feet (2), upper spine (1), and lower back (1), capturing spatiotemporal and kinematic gait parameters.
Pressure-sensing insoles: worn inside participants' shoes to detect gait events (heel strike, toe-off), complementing IMU-derived timing data.
Eye tracker: recording pupil diameter, blink rate, and fixation duration.
EEG cap: records brain's electrical voltage fluctuaction to obtain metrics such as frequency band analysis and neural signals related.
IMUs and insoles are used primarily to obtain gait parameters, whereas eye tracking and EEG are used only during the mental fatigue-inducing computer task, serving as physiological metrics to corroborate fatigue.
Procedures
Practice session (remote, online via PsychoPy/Pavlovia): Participants complete a familiarization run of TloadDback for individual speed calibration
In-person session pipeline:
Demographic questionnaire. Sensor placement: IMUs and insoles Baseline gait trial (10-meter straight-line walk). A 3-minute Psychomotor Vigilance Task (PVT), in which participants respond as quickly as possible by pressing the spacebar each time a visual stimulus (a dot) appears at random inter-stimulus intervals.
Sensor placement: Eye tracker and EEG. TloadDback task (32 minutes continuous). Repeat the 3-minute Psychomotor Vigilance Task (PVT). Take off the Eye Tracker and EEG. Post-task gait and recovery assessment: repeated cycles of a straight-line walk trial followed by a 3-minute rest, for a total of 4 post-task walk assessments.
Visual Analog Scale (VAS) ratings (fatigue, boredom) are collected at multiple points across the session to track the time course of fatigue and alertness.
- Conditions
- Mental Fatigue
- Being tested
- Mental fatigue
- Keywords
- Mental fatigue, Fatigue, Cognitive Fatigue
- Medical subject headings
- Mental Fatigue, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental fatigueOther
Also called Cognitive fatigue
Participants will undergo a mental fatigue induction protocol to examine its effects on gait parameters.
| Study group | Role | What they receive |
|---|---|---|
| Mental fatigue | Experimental | Day 1 (remote): online familiarization session with the TloadDback cognitive task to individually calibrate stimulus speed.
Day 2 (in-person): gait (spatiotemporal parameters and kinematics) is assessed using wearable motion sensors and pressure-sensing insoles, before and repeatedly after a computer task (32-minute TloadDback session), used to induce mental fatigue. Eye tracking and EEG are recorded during the task as physiological fatigue indices. Subjective (VAS) and behavioral (PVT) measures of fatigue and alertness are also collected throughout the session. Receives: Other: Mental fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective fatigue (VAS fatigue rating)
Change in self-reported mental fatigue from baseline (PRE) to immediately after the mental fatigue induction task (POST), measured using the Visual Analog Scale for Fatigue (VAS). The VAS is a single-item, self-report scale ranging from 0 to 10, where 0 indicates "not tired at all" and 10 indicates "extremely tired." Higher scores indicate greater self-reported mental fatigue.
Measured: Right at the beginning of the experiment and right after the 32-minutes TloadDback task
Change in Mean Reaction Time of the Psychomotor Vigilance Task (PVT)
Change in mean reaction time on the Psychomotor Vigilance Task from PRE to POST TloadDback, used as a behavioral indicator of mental fatigue-related vigilance decrement. Slower reaction time in the POST, compared to PRE, means more mentally fatigued.
Measured: Right at the beginning and right after the 32-minute TloadDback cognitive task.
Change in Gait Velocity
Change in gait velocity (meters/second), comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. Here, there is no clear pattern; however, we expect participants to slow their gait spede after the fatigue intervention.
Measured: Right at the beginning and right after the 32-minute TloadDback cognitive task.
Change in Gait Cadence
Change in gait cadence (steps/minute), comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. There is no clear pattern here; however, we are expecting the cadence (steps/minute) to decrease after the fatigue intervention.
Measured: Immediately before and immediately after the 32-minute TloadDback task
Change in Stance and Swing Phase Duration
Change in stance phase duration and swing phase duration, each expressed as a percentage of the gait cycle, comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. Stance phase refers to the portion of the gait cycle when the foot is in contact with the ground, while swing phase refers to the portion when the foot is off the ground and advancing forward. An increase in stance phase duration (with a corresponding decrease in swing phase duration) is generally associated with a more cautious, conservative gait pattern. A decrease in stance phase duration (with a corresponding increase in swing phase) may reflect a faster, less guarded walking pattern.
Measured: Immediately before and immediately after the 32-minute TloadDback task
Change in Lower Extremity Joint Angles (Hip, Knee, Ankle)
Change in peak hip, knee, and ankle joint angles (degrees) during walking, comparing baseline (PRE) walking trials to post-task (Post) walking trials, measured using inertial measurement units. Joint angles reflect the range of motion at each joint during the gait cycle. A reduction in joint angle range (i.e., smaller peak flexion/extension excursions) is commonly interpreted in the literature as a more restricted or cautious movement strategy, sometimes associated with reduced motor control.
Measured: Immediately before and immediately after the 32-minute TloadDback task
Secondary outcomes (8)
Gait Velocity During Post-Task Recovery
Gait velocity (meters/second), measured at 3, 6, 9, and 12 minutes after the TloadDback task, where participants will rest for 3 minutes, walk 10 meters, and repeat this cycle 4 times. The idea is to examine whether and how walking speed changes as participants rest and recover from mental fatigue. Values will be reported separately for each timepoint. We will be expecting the gait velocity to increase after resting.
Measured: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Gait Cadence During Post-Task Recovery
Gait cadence (steps/minute), measured at 3, 6, 9, and 12 minutes after the TloadDback task, where participants will rest for 3 minutes, walk 10 meters, and repeat this cycle 4 times. The idea is to examine whether and how stepping rate changes as participants rest and recover from mental fatigue. Values will be reported separately for each time point.
Measured: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Stance and Swing Phase Duration During Post-Task Recovery
Stance phase duration and swing phase duration, each expressed as a percentage of the gait cycle, measured at 3, 6, 9, and 12 minutes after the TloadDback task, where participants will rest for 3 minutes, walk 10 meters, and repeat this cycle 4 times. The idea is to examine whether and how the distribution of gait phases changes as participants rest and recover from mental fatigue. Values will be reported separately for stance and swing phase at each timepoint. Stance phase is the gait phase where the foot is on the ground, while swing phase is the gait phase where the foot is moving forward (off the ground).
Measured: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Lower Extremity Joint Angles During Post-Task Recovery (Hip/Knee/Ankle)
Peak hip, knee, and ankle joint angles (degrees) during walking, measured at 3, 6, 9, and 12 minutes after the TloadDback task, where participants will rest for 3 minutes, walk 10 meters, and repeat this cycle 4 times. The idea is to examine whether and how the joint range of motion changes as participants rest and recover from mental fatigue. Values will be reported separately for hip, knee, and ankle at each time point.
Measured: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Self-Reported Mental Fatigue During Post-Task Recovery
Self-reported mental fatigue, measured using the Visual Analog Scale for Fatigue (VAS), at 3, 6, 9, and 12 minutes after the TloadDback task, where participants will rest for 3 minutes, walk 10 meters, and repeat this cycle 4 times. The idea is to examine whether and how perceived fatigue changes as participants rest and recover. The VAS ranges from 0 to 10, where 0 indicates "not tired at all" and 10 indicates "extremely tired"; higher scores indicate greater fatigue. Values will be reported separately for each time point.
Measured: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Change in electroencephalography (EEG) Band Spectral Power
Change in relative electroencephalography (EEG) spectral power (%) in theta and alpha frequency bands, recorded during the TloadDback task, providing physiological confirmation of mental fatigue induction. Increases in theta and alpha power, particularly over central and posterior regions, are commonly reported in the literature as indicators of cognitive fatigue accumulation. Values will be reported separately for each frequency band.
Measured: During the 32-minute TloadDback task
Change in Pupil Diameter
Change in pupil diameter (millimeters), recorded during the TloadDback task using eye-tracking, providing physiological confirmation of mental fatigue induction. A decrease in pupil diameter over the course of the task is commonly reported in the literature as an indicator of increasing mental fatigue.
Measured: During the 32-minute TloadDback task
Change in Blink Rate
Change in blink rate (blinks per minute), recorded during the TloadDback task using eye-tracking, providing physiological confirmation of mental fatigue induction. An increase in blink rate over the course of the task is commonly reported in the literature as an indicator of increasing mental fatigue.
Measured: During the 32-minute TloadDback task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Gomez Hernandez, State University of New York at Buffalo
- Investigators
- Lora Cavuoto, PhD, Study chair, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710755
- Sponsor's protocol ID
- STUDY00010729
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on data sharing has not yet been finalized. I intend to complete the IRB review process first, incorporating any feedback or requirements related to data collection, de-identification, and storage. Once IRB approval is obtained, a formal individual participant data (IPD) sharing plan will be developed, taking into account any applicable restrictions on data publication and participant privacy protections.
Publications
Behrens M, Gube M, Chaabene H, Prieske O, Zenon A, Broscheid KC, Schega L, Husmann F, Weippert M. Fatigue and Human Performance: An Updated Framework. Sports Med. 2023 Jan;53(1):7-31. doi: 10.1007/s40279-022-01748-2. Epub 2022 Oct 18.
PubMed 36258141Al-Yahya E, Dawes H, Smith L, Dennis A, Howells K, Cockburn J. Cognitive motor interference while walking: a systematic review and meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):715-28. doi: 10.1016/j.neubiorev.2010.08.008. Epub 2010 Sep 15.
PubMed 20833198Borragan G, Slama H, Destrebecqz A, Peigneux P. Cognitive Fatigue Facilitates Procedural Sequence Learning. Front Hum Neurosci. 2016 Mar 3;10:86. doi: 10.3389/fnhum.2016.00086. eCollection 2016.
PubMed 26973501
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Fatigue on Gait
- ClinicalTrials.gov ID
- NCT07710755
- Acronym / sponsor ID
- STUDY00010729
- Conditions
- Mental Fatigue
- Keywords
- Mental fatigue, Fatigue, Cognitive Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Jul 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 study is to comprehend how mental fatigue could affect human gait. The main questions to answer are:
- Does mental fatigue change how people walk?
- How long does it take for walking patterns to return to normal after mental fatigue sets in?
- What role do constructs like boredom, sleepiness, and motivation play in this relationship?
To achieve this, participants will take part in the experiment, split into two sessions:
Day 1 (online, about 25 minutes): Practice session. Participants will practice a computer task that will be used to induce mental fatigue in the next session.
Day 2 (in-person, about 1.5 to 2 hours): Participants will wear several wearable sensors: motion sensors on their legs, feet, and back, sensor insoles in their shoes, a cap that measures brain activity, and glasses that track eye movement. After sensor placement, participants will walk in a straight line for 10 meters to measure their normal walking pattern. They will then complete a 32-minute computer task designed to induce mental fatigue. Afterward, participants will walk in a straight line for 10 meters again, rest for 3 minutes, and repeat this walk-and-rest cycle 3 more times. Participants will also answer short questions about how tired, bored, and alert they feel throughout the session.
Detailed description
Background:
Most prior research on mental fatigue and gait has examined concurrent dual-task walking, in which a cognitive task and walking occur simultaneously. It remains unclear whether gait is altered following (rather than during) a mentally fatiguing task. This study addresses that gap using TloadDback, an adaptive N-back paradigm (Borragán et al., 2016) that individually calibrates cognitive demand to maintain consistent task difficulty across participants, as the mental fatigue induction method.
Design:
This is a within-subject, repeated-measures design. All primary analyses will be conducted on data collected during the in-person session. Sample size (up to 30 enrolled, target N = 24) was determined via a power analysis using pilot data (N = 5; within-subject design, α = 0.05, power = 0.90).
Mental Fatigue Induction Task:
TloadDback is administered as a single continuous 32-minute block. Participants view a continuous sequence of number-letter-number stimuli and respond via keypress (odd/even number), when seeing a number, or spacebar (letter repeat), when seeing a letter. Stimulus-presentation speed is individually calibrated during the practice session to the maximum speed at which the participant maintains greater than 85% accuracy, ensuring standardized cognitive demand across participants during the main session.
Sensor:
Inertial measurement units (IMUs): 8 units, placed at the shanks (2), thighs (2), feet (2), upper spine (1), and lower back (1), capturing spatiotemporal and kinematic gait parameters.
Pressure-sensing insoles: worn inside participants' shoes to detect gait events (heel strike, toe-off), complementing IMU-derived timing data.
Eye tracker: recording pupil diameter, blink rate, and fixation duration.
EEG cap: records brain's electrical voltage fluctuaction to obtain metrics such as frequency band analysis and neural signals related.
IMUs and insoles are used primarily to obtain gait parameters, whereas eye tracking and EEG are used only during the mental fatigue-inducing computer task, serving as physiological metrics to corroborate fatigue.
Procedures
Practice session (remote, online via PsychoPy/Pavlovia): Participants complete a familiarization run of TloadDback for individual speed calibration
In-person session pipeline:
Demographic questionnaire. Sensor placement: IMUs and insoles Baseline gait trial (10-meter straight-line walk). A 3-minute Psychomotor Vigilance Task (PVT), in which participants respond as quickly as possible by pressing the spacebar each time a visual stimulus (a dot) appears at random inter-stimulus intervals.
Sensor placement: Eye tracker and EEG. TloadDback task (32 minutes continuous). Repeat the 3-minute Psychomotor Vigilance Task (PVT). Take off the Eye Tracker and EEG. Post-task gait and recovery assessment: repeated cycles of a straight-line walk trial followed by a 3-minute rest, for a total of 4 post-task walk assessments.
Visual Analog Scale (VAS) ratings (fatigue, boredom) are collected at multiple points across the session to track the time course of fatigue and alertness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental fatigue | Experimental | Other: Mental fatigueDay 1 (remote): online familiarization session with the TloadDback cognitive task to individually calibrate stimulus speed. Day 2 (in-person): gait (spatiotemporal parameters and kinematics) is assessed using wearable motion sensors and pressure-sensing insoles, before and repeatedly after a computer task (32-minute TloadDback session), used to induce mental fatigue. Eye tracking and EEG are recorded during the task as physiological fatigue indices. Subjective (VAS) and behavioral (PVT) measures of fatigue and alertness are also collected throughout the session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-60 years.
- Neurotypical individuals with no self-reported history of neurological or cognitive disorders.
- Able to walk independently, without an assistive device.
- Fluent in English.
- Recruitment will aim for gender balance across the sample.
Key exclusion criteria (7 listed)
- Outside the age range of 18-60 years.
- Self-reported history of neurological or cognitive disorders (e.g., epilepsy, multiple sclerosis, stroke/traumatic brain injury).
- Any musculoskeletal condition or injury affecting normal gait.
- Use of an assistive device for walking (e.g., cane, walker, brace).
- Self-reported photosensitive epilepsy or seizure disorder triggered by screen/visual stimuli.
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 fatigueAlso: Cognitive fatigueParticipants will undergo a mental fatigue induction protocol to examine its effects on gait parameters. | Other | Mental fatigue |
Primary outcome
Subjective fatigue (VAS fatigue rating)
Time frame: Right at the beginning of the experiment and right after the 32-minutes TloadDback task
Change in self-reported mental fatigue from baseline (PRE) to immediately after the mental fatigue induction task (POST), measured using the Visual Analog Scale for Fatigue (VAS). The VAS is a single-item, self-report scale ranging from 0 to 10, where 0 indicates "not tired at all" and 10 indicates "extremely tired." Higher scores indicate greater self-reported mental fatigue.
Change in Mean Reaction Time of the Psychomotor Vigilance Task (PVT)
Time frame: Right at the beginning and right after the 32-minute TloadDback cognitive task.
Change in mean reaction time on the Psychomotor Vigilance Task from PRE to POST TloadDback, used as a behavioral indicator of mental fatigue-related vigilance decrement. Slower reaction time in the POST, compared to PRE, means more mentally fatigued.
Change in Gait Velocity
Time frame: Right at the beginning and right after the 32-minute TloadDback cognitive task.
Change in gait velocity (meters/second), comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. Here, there is no clear pattern; however, we expect participants to slow their gait spede after the fatigue intervention.
Change in Gait Cadence
Time frame: Immediately before and immediately after the 32-minute TloadDback task
Change in gait cadence (steps/minute), comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. There is no clear pattern here; however, we are expecting the cadence (steps/minute) to decrease after the fatigue intervention.
Change in Stance and Swing Phase Duration
Time frame: Immediately before and immediately after the 32-minute TloadDback task
Change in stance phase duration and swing phase duration, each expressed as a percentage of the gait cycle, comparing baseline (PRE) walking trials to post-task (POST) walking trials, measured using inertial measurement units and pressure-sensing insoles. Stance phase refers to the portion of the gait cycle when the foot is in contact with the ground, while swing phase refers to the portion when the foot is off the ground and advancing forward. An increase in stance phase duration (with a corresponding decrease in swing phase duration) is generally associated with a more cautious, conservative gait pattern. A decrease in stance phase duration (with a corresponding increase in swing phase) may reflect a faster, less guarded walking pattern.
Change in Lower Extremity Joint Angles (Hip, Knee, Ankle)
Time frame: Immediately before and immediately after the 32-minute TloadDback task
Change in peak hip, knee, and ankle joint angles (degrees) during walking, comparing baseline (PRE) walking trials to post-task (Post) walking trials, measured using inertial measurement units. Joint angles reflect the range of motion at each joint during the gait cycle. A reduction in joint angle range (i.e., smaller peak flexion/extension excursions) is commonly interpreted in the literature as a more restricted or cautious movement strategy, sometimes associated with reduced motor control.
8 secondary outcomes
Gait Velocity During Post-Task Recovery
Time frame: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Gait Cadence During Post-Task Recovery
Time frame: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Stance and Swing Phase Duration During Post-Task Recovery
Time frame: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Lower Extremity Joint Angles During Post-Task Recovery (Hip/Knee/Ankle)
Time frame: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Self-Reported Mental Fatigue During Post-Task Recovery
Time frame: 3, 6, 9, and 12 minutes after the 32-minute TloadDback task
Change in electroencephalography (EEG) Band Spectral Power
Time frame: During the 32-minute TloadDback task
Change in Pupil Diameter
Time frame: During the 32-minute TloadDback task
Change in Blink Rate
Time frame: During the 32-minute TloadDback task
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 17 Jul 2026.
- Background: PubMed 36258141Behrens M, Gube M, Chaabene H, Prieske O, Zenon A, Broscheid KC, Schega L, Husmann F, Weippert M. Fatigue and Human Performance: An Updated Framework. Sports Med. 2023 Jan;53(1):7-31. doi: 10.1007/s40279-022-01748-2. Epub 2022 Oct 18.
- Background: PubMed 20833198Al-Yahya E, Dawes H, Smith L, Dennis A, Howells K, Cockburn J. Cognitive motor interference while walking: a systematic review and meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):715-28. doi: 10.1016/j.neubiorev.2010.08.008. Epub 2010 Sep 15.
- Background: PubMed 26973501Borragan G, Slama H, Destrebecqz A, Peigneux P. Cognitive Fatigue Facilitates Procedural Sequence Learning. Front Hum Neurosci. 2016 Mar 3;10:86. doi: 10.3389/fnhum.2016.00086. eCollection 2016.
- Individual participant dataSharing planned: Undecided. A decision on data sharing has not yet been finalized. I intend to complete the IRB review process first, incorporating any feedback or requirements related to data collection, de-identification, and storage. Once IRB approval is obtained, a formal individual participant data (IPD) sharing plan will be developed, taking into account any applicable restrictions on data publication and participant privacy protections.
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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.
Lora Cavuoto, PhD study chair
University at Buffalo
Questions about this trial
What is this clinical trial studying?
A study testing Mental fatigue in people with Mental Fatigue, run by State University of New York at Buffalo.
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 6 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: opening soon, as of the sponsor's last update on 17 Jul 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?
Contact Alexis M Gomez Hernandez (330-554-0868 ext. PhD Candidate, agomezhe@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective fatigue (VAS fatigue rating) (time frame: Right at the beginning of the experiment and right after the 32-minutes TloadDback task). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07710755, which also lists 3 linked publications.
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 17 Jul 2026.