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

NCT03994952 | Completed FDA Device

• 1 other identifier: 0454-19-EP
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Balance, postural; Non-linear dynamics

Outcome Measures

Primary Outcomes (1)

• Bland-Altman Analysis

  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 Outcomes (3)

• Sway Balance Score

  Immediate

• Balance Error Scoring System

  Immediate

• Sample Entropy of the center of pressure

  Immediate

Study Arms (1)

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; Device: Balance Tracking Systems

Interventions

Sway Balance Application 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.

Uninjured Physically Active Young Adults

Balance Tracking Systems 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.

Uninjured Physically Active Young Adults

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

Study Officials

• Christopher J Burcal, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: August 6, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)