How's Your Balance?

February 16, 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.

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 attempt to stand on one leg as long as they can up to 30 or 60 seconds.

Study Overview

Status

Active, not 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, unipedal 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.

Last, this investigation will evaluate how well the PROMIS PROWalk questionnaire reflects or relates to an individual's balance and mobility capabilities in a general population. The PROMIS PROWalk questionnaire is a subset of questions from the PROMIS databank, focused on a person's self-reported ability to walk and perform lower body tasks, including walking various distances, climbing stairs, and navigating different terrains.

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 Locations

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

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 21 and older
  • Able to provide verbal consent

Exclusion Criteria:

  • Individuals, ages 20 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
Monofilament Testing
Time Frame: About 5 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. Including catch trials helps to ensure accurate test results. 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 5 minutes of a single 20-minute session
Single Leg Stance
Time Frame: About 5 minutes of a single 20-minute session
The Single Leg Stance Test (also called the unipedal stance test) "is a simple test for measuring static aspects of balance." It "is related to conditions such as peripheral neuropathy and intermittent claudication" and "is also associated with an increased risk for falls" (Spring et al., 2007) Participants stand unassisted on one leg with their hands on their hips. Timing begins when they lift one leg off the floor and ends when it touches the ground or the standing leg or an arm leaves the hips
About 5 minutes of a single 20-minute session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS® Physical Function v2.0 PROWalk
Time Frame: About 5 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 5 minutes of a single 20-minute session
Demographic Information
Time Frame: About 5 minutes of a single 20-minute session
We will continue to collect information about the participants: age, sex, race, ethnicity, fall history, diagnosis of diabetes, diagnosis of peripheral neuropathy, etc. No Protected Health Information (PHI) will be collected.
About 5 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)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 16, 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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