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Clinical Trials/NCT07710755
NCT07710755Not yet recruitingNot Applicable

Effects of Cognitive Fatigue on Gait

State University of New York at Buffalo0 sites30 target enrollmentStarted: September 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Subjective fatigue (VAS fatigue rating)

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Change in electroencephalography (EEG) Band Spectral Power(During the 32-minute TloadDback task)
  • Change in Pupil Diameter(During the 32-minute TloadDback task)
  • Change in Blink Rate(During the 32-minute TloadDback task)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexis Gomez Hernandez

Principal Investigator

State University of New York at Buffalo

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