- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713383
The Role of Perturbed Auditory Information for Self-motion in Gait
September 28, 2023 updated by: University of Nebraska
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.
Study Overview
Detailed Description
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.
Eligibility is based on inclusion and exclusion criteria determined via a self-report questionnaire.
The inclusion criteria are age and overall health status (young healthy adults, 19-35) and self-reported ability to walk comfortably for half an hour.
Exclusion criteria include known hearing impairment, history of back or lower extremity injury, surgery that affects mobility, neurological disease or impairment that limits the ability to walk (Cerebral palsy).
The study will randomly split the participants in a control and experimental group.
Participants will perform trials in one condition only, quiet walking or control.
Participants will visit the lab five times in the span of two weeks.
The first and last sessions will serve for pre-post comparisons.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dobromir Dotov, PhD
- Phone Number: (531) 263-0732
- Email: ddotov@unomaha.edu
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68182
- University of Nebraska-Omaha, Department of Biomechanics,
-
Contact:
- Dobromir Dotov, PhD
- Phone Number: 402-554-4194
- Email: ddotov@unomaha.edu
-
Contact:
- Jessica Hilt
- Phone Number: 402-554-3228
- Email: jessicahilt@unomaha.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- self-reported tolerance to 30 minute exercise
- self-reported ability to walk comfortably for half an hour
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Walking
Walking normally without restriction
|
|
Experimental: Walking Quietly
Participants instructed to make little noise while walking.
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Sound amplification is used to accentuate participants' footsteps, while asking them to step softly so as to reduce this sound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait instability measured with the maximum Lyapunov exponent (MLE)
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dobromir Dotov, PhD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
August 30, 2025
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 26, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0794-22-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share personal data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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