How's Your Balance?

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorRxFunction Inc.

About this trial

The goals of this observational study are to investigate the following:

* If there is a relationship between prior falls, single leg stance time, and plantar cutaneous sensitivity as measured by monofilaments. * Plantar sensitivity across a broad range of ages. * Self-reported physical function related to balance and mobility using the PROMIS® PROWalk™ questionnaire and balance confidence using the Activities-specific Balance Confidence Scale-6 (ABC-6).

Participants will answer questions about themselves and their balance and falls. Their plantar (bottom of their feet) sensation will also be tested using monofilaments. And they will stand on a force plate with their eyes open and closed in dual and single leg stances for up to 30 seconds.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults, ages 20 and older

Able to provide verbal consent

Disqualifiers

Individuals, ages 19 and younger

Inability to provide verbal consent

Trial population

The study population is a convenience sample of individuals who agree to participate in research conducted at the Driven to Discover Research Facility at the Fair.

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

  • None AHT

    Other intervention

    This is an observational study that does not involve any intervention.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: State Fair Attendees1 intervention

Trial outcomes

Primary outcomes

1

Dual- and Single-Leg Quiet Standing Tests

The dual- and single-leg quiet standing tests are static balance assessments used to quantify postural sway under eyes-open and eyes-closed conditions. These tests will be performed on a force plate to determine Romberg ratios. The Romberg ratio compares sway when visual input is removed to sway when visual input is available, providing an index of visual dependence and sensory contribution to upright balance.

Time frame
About 4-5 minutes of a single 20-minute session

Secondary outcomes

1

Anthropometric Information

We will collect information about the participants: age, sex, race, ethnicity, fall history, diagnosis of prediabetes or diabetes, diagnosis of peripheral neuropathy, etc. No Protected Health Information (PHI) will be collected.

Time frame
About 4-5 minutes of a single 20-minute session
2

PROMIS® Physical Function v2.0 PROWalk

Nine items were selected from the 165 items comprising the PROMIS Item Bank v2.0 - Physical Function. Specifically, the selected items measure an individual's ability to perform various activities that involve upright mobility (balance, standing, and walking). Participants rate the nine items on a scale of 1 to 5; the raw scores are converted to T-scores for comparison to national norms.

Time frame
About 2-3 minutes of a single 20-minute session
3

Activities-specific Balance Confidence Scale-6 (ABC-6)

Powell and Myers developed the 16-item Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in older adults. Schepens et al. (2009) validated a 6-item version of the ABC, using the six most challenging activities from the 16-item scale. The six tasks are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (6). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance.

Time frame
2-3 minutes of a single 20-minute session
4

International Physical Activity Questionnaire (IPAQ)-Short Form

The International Physical Activity Questionnaire (IPAQ) is a standardized self-report instrument used to assess physical activity across populations. It captures time spent walking, performing moderate and vigorous physical activity, and sitting, typically over the previous 7 days. The IPAQ is available in short and long forms; the short form is commonly used for surveillance and prevalence studies. Responses can be scored to estimate total physical activity, often expressed as MET (Metabolic Equivalent of Task)-minutes per week, and to classify activity levels as low, moderate, or high.

Time frame
About 2-3 minutes of a single 20-minute session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.