Clinical trial NCT03994952: Comparison of a Non-linear Analysis of Balance During the mBESS to the Sway Balance Application
Official title: Comparison of a Non-linear Analysis of Balance During the mBESS to the Sway Balance Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Balance, postural
Non-linear dynamics
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Bland-Altman Analysis
timeFrame: through study completion, approximately 6 months
Secondary outcomes:
measure: Sway Balance Score
timeFrame: Immediate
measure: Balance Error Scoring System
timeFrame: Immediate
measure: Sample Entropy of the center of pressure
timeFrame: Immediate
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska at Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Christopher J Burcal, PhD
role: PRINCIPAL_INVESTIGATOR
References: