NCT07710755

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

July 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 6, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

Mental fatigueFatigueCognitive Fatigue

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Immediately before and immediately after the 32-minute TloadDback task

Secondary Outcomes (8)

  • Gait Velocity During Post-Task Recovery

    3, 6, 9, and 12 minutes after the 32-minute TloadDback task

  • Gait Cadence During Post-Task Recovery

    3, 6, 9, and 12 minutes after the 32-minute TloadDback task

  • Stance and Swing Phase Duration During Post-Task Recovery

    3, 6, 9, and 12 minutes after the 32-minute TloadDback task

  • Lower Extremity Joint Angles During Post-Task Recovery (Hip/Knee/Ankle)

    3, 6, 9, and 12 minutes after the 32-minute TloadDback task

  • Self-Reported Mental Fatigue During Post-Task Recovery

    3, 6, 9, and 12 minutes after the 32-minute TloadDback task

  • +3 more secondary outcomes

Study Arms (1)

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.

Other: Mental fatigue

Interventions

Participants will undergo a mental fatigue induction protocol to examine its effects on gait parameters.

Also known as: Cognitive fatigue
Mental fatigue

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 36258141BACKGROUND
  • Al-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.

    PMID: 20833198BACKGROUND
  • Borragan 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.

    PMID: 26973501BACKGROUND

MeSH Terms

Conditions

Mental FatigueFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Lora Cavuoto, PhD

    University at Buffalo

    STUDY CHAIR

Central Study Contacts

Alexis M Gomez Hernandez

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 17, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07