NCT05713383

Brief Summary

As people walk and interact with objects such as when opening a door, their movements make sounds. It is possible that these sounds are also used as feedback to stabilize and adapt movement. There is some evidence for such a connection between the auditory and motor systems in activities of daily living, yet the empirical work is insufficient because the role of the auditory system in movement is a relatively neglected topic. The objective of this study is to address this gap. The study will also evaluate the potential for improvements in movement stability and variability by restricting or augmenting the auditory feedback from the participants' footstep sounds.

Trial Health

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Trial Health Score

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

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

January 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 16, 2026

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

January 6, 2023

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gait instability measured with the maximum Lyapunov exponent (MLE)

    The MLE is sensitive to the degree to which the gait cycle tends to diverge from its average repeated pattern. It is typically computed with the Rosenstein algorithm applied to motion-tracking data recorded while the participant is walking. More specifically, the marker is placed on the participant's upper body close to the center-of-mass. MLE equal to zero indicates a neutrally stable dynamic with perfectly repeatable oscillation. Paradoxically, this is maladaptive. Very low values of MLE close to zero tend to be associated with motor disorders. Increasingly positive values of MLE correspond to higher tolerance for dynamic instability and are associated with a healthy gait pattern. There are also exceptions, not relevant to the present study, where very high instability corresponds to specific motor disorders.

    The time frame to measure changes in the outcome variable is two weeks, from the first to last measurement. The time frame to obtain one sample is a few minutes of walking.

Study Arms (2)

Walking

NO INTERVENTION

Walking normally without restriction

Walking Quietly

EXPERIMENTAL

Participants instructed to make little noise while walking.

Behavioral: Auditory Feedback

Interventions

Sound amplification is used to accentuate participants' footsteps, while asking them to step softly so as to reduce this sound.

Walking Quietly

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self-reported tolerance to 30 minute exercise
  • self-reported ability to walk comfortably for half an hour

You may not qualify if:

  • known hearing or visual impairment
  • currently being pregnant
  • history of back or lower extremity injury, surgery that affects mobility, and neurological disease or impairment that limit the ability to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Omaha, Department of Biomechanics,

Omaha, Nebraska, 68182, United States

Location

Study Officials

  • Dobromir Dotov, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 6, 2023

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 16, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations