Comparison of a Non-linear Analysis of Balance During the mBESS to the Sway Balance Application

October 1, 2024 updated by: University of Nebraska
In order to determine equivalency of the Avert Sample Entropy algorithm's ability to be sensitive to different balance conditions, participants will complete the modified balance error scoring system (mBESS) while standing on a portable force platform. Human-rated errors during the mBESS conditions will be recorded, in addition to measuring balance using the Sway app. These will be compared for levels of agreement and direction of bias using Bland-Altman analyses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This investigation will utilize a single session of data collection, which should last no longer than 10 minutes per participant. During this session, the investigators will obtain informed consent, and then the participant will complete a balance test comprised of five, 20-second trials.

The testing procedures are as follows. All participants will perform the mBESS protocol as outlined by the Sway Balance Application. This protocol consists of a total of 5 balance trials, each being 20 seconds in duration. Every balance trial is completed with the eyes closed. Each trial has a different stance configuration: eyes closed feet together, eyes closed right tandem stance (one foot in front of the other, touching the toe to the heel), eyes closed left tandem stance, eyes closed right foot balance, eyes closed left foot balance.

During the test, the participant will hold an iPad mini to their torso, right in front of their sternum and follow the audio prompts to begin balancing and when the balance trial is over. The participant will be given instructions that they can change their stance if they lose their balance, and take a compensatory step if they need it to catch their balance. The participant will be standing on a Balance Tracking Systems force platform for each test, in order to capture an additional objective measurement of their balance. The participant will be asked to ensure they have at least one foot in contact with the plate during each trial.

If a participant should step off of the force platform during an individual trial, the participant will re-do that balance condition to ensure that each participant has one complete 20-second trial that has a score from the Sway app, as well as a full 20-second dataset from the force platform.

The PI will also perform BESS scoring during each trial, and count errors during the testing session. An error is defined as a participant meeting one of the following criteria: moving the hands from the iPad, opening the eyes, step stumble or fall, abduction or flexion of the hip beyond 30°, lifting the forefoot or heel off of the testing surface, remaining out of the proper testing position for greater than 5 seconds. Each trial, or condition can have a maximum of 10 errors. If a subject commits multiple errors simultaneously, only one error is recorded. For example, if an individual steps or stumbles, opens their eyes, and removes their hands from their hips simultaneously, then they are credited with only one error.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68182
        • University of Nebraska at Omaha

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Volunteers will be recruited from the University of Nebraska at Omaha campus community, and we aim to include both undergraduate and graduate students. The sample aims to reflect a young, uninjured, and physically active population.

Description

Inclusion Criteria:

  • Must participate in at least 120 minutes of self-reported leisure-time physical activity.

Exclusion Criteria:

  • Individual has had a concussion within the past 3 months
  • Individual is currently going through rehabilitation for a musculoskeletal injury
  • Individual has a known neurological disorder that would affect their balance (e.g. vertigo, meniere's disease)
  • A female volunteer reports they are pregnant

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Uninjured Physically Active Young Adults

This is a group of physically active, and currently uninjured young adults. They will complete a single balance assessment, the modified balance error scoring system protocol, as outlined by the Sway Balance application.

There is no comparison group for this investigation.
Device: Sway Balance Application
Participants complete the modified Balance Error Scoring System as prompted on and iPad mini. It has 5 balance stances, double limb stance, right tandem, left tandem, right single, and left single leg balance for 20 seconds each. This will only be used as measurement, not an intervention.
Device: Balance Tracking Systems
This is a force platform. Center of pressure data will be measured and recorded while participants are completing the modified Balance Error Scoring System. This will only be used as measurement, not an intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bland-Altman Analysis
Time Frame: through study completion, approximately 6 months
Limits of agreement between measures and bias estimates will be calculated to determine the agreement between the 3 different balance measurement techniques.
through study completion, approximately 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sway Balance Score
Time Frame: Immediate
Score between 0 and 100 from a proprietary algorithm. A score of 0 indicates poor balance based off of measured sway. A score of 100 indicates excellent balance based off of the measurement of postural sway from a smart phone.
Immediate
Balance Error Scoring System
Time Frame: Immediate
The Balance Error Scoring System is a subjective rating of errors during standing balance. Errors are marked when: moving the hands from the iPad, opening the eyes, step stumble or fall, abduction or hip flexion beyond 30°, lifting the forefoot or heel off the ground, being out of testing position for greater than 5 seconds.
Immediate
Sample Entropy of the center of pressure
Time Frame: Immediate
Non-linear measure of the tendency of a pattern of a given data length will repeat. Values range between 0 and 2. Values closer to 0 indicate highly regular and predictable signals with patterns. Values closer to 2 indicate less regular signals, with less predictability and more randomness. Analysis performed in MATLAB from the center of pressure data recorded from the Balance Tracking Systems force platform.
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher J Burcal, 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0454-19-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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