How's Your Balance?

NCT07412145 | Active Not Recruiting

• 1 other identifier: CIP 0011
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Balance Assessment; Falls; Plantar Sensation

Keywords

Balance; Falls; Plantar sensation

Outcome Measures

Primary Outcomes (2)

• Monofilament Testing

  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

  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 Outcomes (2)

• 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

Study Arms (1)

State Fair Attendees

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

Other: None AHT

Interventions

None AHT OTHER

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

State Fair Attendees

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults, ages 21 and older
• Able to provide verbal consent

You may not qualify if:

• Individuals, ages 20 and younger
• Inability to provide verbal consent

Sponsors & Collaborators

• RxFunction Inc.: lead

Study Sites (1)

Driven to Discover Research Facility at the Minnesota State Fair

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (15)

• Wood WA, Wood MA, Werter SA, Menn JJ, Hamilton SA, Jacoby R, Dellon AL. Testing for loss of protective sensation in patients with foot ulceration: a cross-sectional study. J Am Podiatr Med Assoc. 2005 Sep-Oct;95(5):469-74. doi: 10.7547/0950469.

  PMID: 16166466 BACKGROUND

• Verghese J, Holtzer R, Lipton RB, Wang C. Quantitative gait markers and incident fall risk in older adults. J Gerontol A Biol Sci Med Sci. 2009 Aug;64(8):896-901. doi: 10.1093/gerona/glp033. Epub 2009 Apr 6.

  PMID: 19349593 BACKGROUND

• Araujo CG, de Souza E Silva CG, Laukkanen JA, Fiatarone Singh M, Kunutsor SK, Myers J, Franca JF, Castro CL. Successful 10-second one-legged stance performance predicts survival in middle-aged and older individuals. Br J Sports Med. 2022 Sep;56(17):975-980. doi: 10.1136/bjsports-2021-105360. Epub 2022 Jun 21.

  PMID: 35728834 BACKGROUND

• Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

  PMID: 21205966 BACKGROUND

• Saltzman CL, Rashid R, Hayes A, Fellner C, Fitzpatrick D, Klapach A, Frantz R, Hillis SL. 4.5-gram monofilament sensation beneath both first metatarsal heads indicates protective foot sensation in diabetic patients. J Bone Joint Surg Am. 2004 Apr;86(4):717-23. doi: 10.2106/00004623-200404000-00008.

  PMID: 15069135 BACKGROUND

• Rothrock NE, Kaat AJ, Vrahas MS, O'Toole RV, Buono SK, Morrison S, Gershon RC. Validation of PROMIS Physical Function Instruments in Patients With an Orthopaedic Trauma to a Lower Extremity. J Orthop Trauma. 2019 Aug;33(8):377-383. doi: 10.1097/BOT.0000000000001493.

  PMID: 31085947 BACKGROUND

• Richardson JK, Hurvitz EA. Peripheral neuropathy: a true risk factor for falls. J Gerontol A Biol Sci Med Sci. 1995 Jul;50(4):M211-5. doi: 10.1093/gerona/50a.4.m211.

  PMID: 7614243 BACKGROUND

• Perry SD. Evaluation of age-related plantar-surface insensitivity and onset age of advanced insensitivity in older adults using vibratory and touch sensation tests. Neurosci Lett. 2006 Jan 9;392(1-2):62-7. doi: 10.1016/j.neulet.2005.08.060. Epub 2005 Sep 23.

  PMID: 16183200 BACKGROUND

• Parsons SL, Mansfield A, Inness EL, Patterson KK. The relationship of plantar cutaneous sensation and standing balance post-stroke. Top Stroke Rehabil. 2016 Oct;23(5):326-32. doi: 10.1080/10749357.2016.1162396. Epub 2016 Mar 31.

  PMID: 27077993 BACKGROUND

• Nakamoto M, Ideguchi N, Iwata S, Tomita S, Morimoto N, Fukuda S, Kudo S. Validity and Reliability of Criteria for Plantar Sensation Assessment Using Semmes-Weinstein Monofilament as a Clinically Usable Index. Int J Environ Res Public Health. 2022 Oct 28;19(21):14092. doi: 10.3390/ijerph192114092.

  PMID: 36360967 BACKGROUND

• Meyer PF, Oddsson LI, De Luca CJ. The role of plantar cutaneous sensation in unperturbed stance. Exp Brain Res. 2004 Jun;156(4):505-12. doi: 10.1007/s00221-003-1804-y. Epub 2004 Feb 14.

  PMID: 14968274 BACKGROUND

• Hicks CW, Wang D, Daya N, Juraschek SP, Matsushita K, Windham BG, Selvin E. The association of peripheral neuropathy detected by monofilament testing with risk of falls and fractures in older adults. J Am Geriatr Soc. 2023 Jun;71(6):1902-1909. doi: 10.1111/jgs.18338. Epub 2023 Mar 21.

  PMID: 36945108 BACKGROUND

• Doi T, Nakakubo S, Tsutsumimoto K, Kurita S, Ishii H, Shimada H. Spatiotemporal gait characteristics and risk of mortality in community-dwelling older adults. Maturitas. 2021 Sep;151:31-35. doi: 10.1016/j.maturitas.2021.06.007. Epub 2021 Jun 24.

  PMID: 34446276 BACKGROUND

• Carrer P, Trevisan C, Curreri C, Giantin V, Maggi S, Crepaldi G, Manzato E, Sergi G. Semmes-Weinstein Monofilament Examination for Predicting Physical Performance and the Risk of Falls in Older People: Results of the Pro.V.A. Longitudinal Study. Arch Phys Med Rehabil. 2018 Jan;99(1):137-143.e1. doi: 10.1016/j.apmr.2017.08.480. Epub 2017 Sep 20.

  PMID: 28939426 BACKGROUND

• Bretan O, Pinheiro RM, Corrente JE. Balance and plantar cutaneous sensitivity functional assessment in community-dwelling elderly. Braz J Otorhinolaryngol. 2010 Mar-Apr;76(2):219-24. doi: 10.1590/S1808-86942010000200012.

  PMID: 20549083 BACKGROUND

Related Links

• Driven to Discover Research Facility at the Minnesota State Fair

Study Officials

• Lars Oddsson, PhD

  RxFunction Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: August 23, 2025
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)