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Clinical Trials/NCT07412145
NCT07412145RecruitingNot Applicable

How's Your Balance?

RxFunction Inc.1 site in 1 country1,000 target enrollmentStarted: August 23, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
Monofilament Testing

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

State Fair Attendees

Adults (age 20+) attending the Minnesota State Fair who agree to participate comprise the study group.

Intervention: None AHT (Other)

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

  • PROMIS® Physical Function v2.0 PROWalk(About 5 minutes of a single 20-minute session)
  • Demographic Information(About 5 minutes of a single 20-minute session)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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