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Effects of Cognitive Fatigue on Gait

No phase Interventional Mental Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mental fatigue.
Who it may be relevant to
Registry conditions: Mental Fatigue. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Subjective fatigue (VAS fatigue rating) [Time frame: 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) [Time frame: Right at the beginning and right after the 32-minute TloadDback cognitive task.]
  • Change in Gait Velocity [Time frame: Right at the beginning and right after the 32-minute TloadDback cognitive task.]
  • Change in Gait Cadence [Time frame: Immediately before and immediately after the 32-minute TloadDback task]
  • Change in Stance and Swing Phase Duration [Time frame: Immediately before and immediately after the 32-minute TloadDback task]
  • Change in Lower Extremity Joint Angles (Hip, Knee, Ankle) [Time frame: Immediately before and immediately after the 32-minute TloadDback task]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 36258141
  • 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 20833198
  • 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 26973501

Identifiers

NCT: NCT07710755 · STUDY00010729

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗