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

NCT ID: NCT03994952

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2020-03-02

Brief Summary

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.

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Sway Balance Application

Intervention Type: DEVICE

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.

Balance Tracking Systems

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Burcal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska at Omaha

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0454-19-EP

Identifier Type: -

Identifier Source: org_study_id