How's Your Balance?

June 22, 2026 updated by: RxFunction Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preserving sensory function, particularly in the feet, is essential for preventing falls and maintaining autonomy and health across the human lifespan. Monofilament testing is a widely used clinical tool for assessing foot sensation. In older adults, this test typically involves applying a standardized nylon filament (commonly the 10g monofilament) to specific sites on the plantar surface of the foot. Loss of sensation detected through monofilament testing often indicates peripheral neuropathy, which can be caused by aging, diabetes, or other conditions affecting nerve function. This sensory impairment significantly impacts postural control by reducing the afferent feedback needed for postural adjustments. Thus, monofilament testing serves as a diagnostic tool and a predictor of fall risk, emphasizing the critical role of sensory feedback in maintaining stability and preventing injury in aging populations.

In addition to monofilament testing, single leg stance time is a strong indicator of balance, functional, and neurological health, with shorter times signaling higher fall risks, particularly in older adults. The unipedal or single leg (limb) stance test measures static postural control and is a valuable, quick screening tool in clinical settings to identify individuals in need of further evaluation or rehabilitation. Inability to hold a one-leg stand for at least 5 seconds is a red flag for potential balance issues, while a 30-second hold indicates good stability. We will expand on existing research by examining plantar sensitivity across ages and exploring links between fall history, unipedal stance time, and plantar cutaneous sensation.

Primary Research Question/Hypothesis What is the relationship between physiological aging and Romberg ratio values during standing balance, and how well can age and somatosensory function explain variation in Romberg ratio values? We hypothesize that older age and reduced somatosensory function will be associated with higher Romberg ratio values (i.e., stronger dependence on vision, suggestive of somatosensory deficits) during standing balance.

Secondary Research Question(s)/Hypothesis

  • To what extent does plantar cutaneous sensitivity at different foot sites relate to Romberg ratio values during standing balance, and which site(s) remain significant predictors after controlling for age? We believe that reduced plantar cutaneous sensitivity (higher monofilament thresholds) at medial foot sites will be associated with higher Romberg ratio values, independent of age.
  • How are standing Romberg ratio values related to self-reported physical function (PROMIS® PROWalk™) and balance confidence (ABC-6) across different ages? We hypothesize that self-reported physical function and balance confidence will be significant predictors of standing Romberg ratio values, such that lower PROMIS® PROWalk™ scores and lower ABC-6 scores are associated with higher Romberg ratio values, independent of age.
  • We will continue to evaluate whether the threshold for loss of balance sensation is lower than that for loss of protective sensation (i.e., inability to feel a 10g monofilament at 2 of 5 sites on the plantar surface of the foot). We hypothesize that impaired balance will be associated with reduced or absent plantar cutaneous sensation, regardless of age.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55108
        • Recruiting
        • Driven to Discover Research Facility at the Minnesota State Fair
        • Contact:
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Adults, ages 20 and older
  • Able to provide verbal consent

Exclusion Criteria:

  • Individuals, ages 19 and younger
  • Inability to provide verbal consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
State Fair Attendees
Adults (age 20+) attending the Minnesota State Fair who agree to participate comprise the study group.
Other: None AHT
This is an observational study that does not involve any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual- and Single-Leg Quiet Standing Tests
Time Frame: About 4-5 minutes of a single 20-minute session
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.
About 4-5 minutes of a single 20-minute session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric Information
Time Frame: About 4-5 minutes of a single 20-minute session
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.
About 4-5 minutes of a single 20-minute session
PROMIS® Physical Function v2.0 PROWalk
Time Frame: About 2-3 minutes of a single 20-minute session
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.
About 2-3 minutes of a single 20-minute session
Activities-specific Balance Confidence Scale-6 (ABC-6)
Time Frame: 2-3 minutes of a single 20-minute session
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.
2-3 minutes of a single 20-minute session
International Physical Activity Questionnaire (IPAQ)-Short Form
Time Frame: About 2-3 minutes of a single 20-minute session
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.
About 2-3 minutes of a single 20-minute session
Monofilament Testing
Time Frame: About 2 minutes of a single 20-minute session
The Centers for Medicare & Medicaid Services (CMS) identifies the monofilament test as the means of diagnosing loss of protective sensation (https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=171). To conduct the test, a clinician applies pressure with various sizes of monofilament to selected parts of the foot and asks the participant to indicate when he/she feels the filament. Per CMS, inability to feel a 10-gram monofilament on at least two of five test sites on either foot indicates loss of protective sensation (LOPS).
About 2 minutes of a single 20-minute session

Collaborators and Investigators

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

Sponsor

RxFunction Inc.

Investigators

  • Principal Investigator: Lars Oddsson, PhD, RxFunction Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 23, 2025

Primary Completion (Estimated)

September 10, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIP 0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sponsor will make a determination on data sharing prior to publication of the results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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