NCT07412145

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Aug 2025Dec 2028

Study Start

First participant enrolled

August 23, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

February 9, 2026

Last Update Submit

June 22, 2026

Conditions

Balance AssessmentFallsPlantar Sensation

Keywords

BalanceFallsPlantar sensation

Outcome Measures

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.

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

Secondary Outcomes (5)

  • Anthropometric Information

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

  • PROMIS® Physical Function v2.0 PROWalk

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

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

    2-3 minutes of a single 20-minute session

  • International Physical Activity Questionnaire (IPAQ)-Short Form

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

  • Monofilament Testing

    About 2 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 AHTOTHER

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

State Fair Attendees

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 20 and older
  • Able to provide verbal consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Driven to Discover Research Facility at the Minnesota State Fair

Saint Paul, Minnesota, 55108, United States

RECRUITING

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: 16166466BACKGROUND

  • 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: 19349593BACKGROUND

  • 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: 35728834BACKGROUND

  • 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: 21205966BACKGROUND

  • 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: 15069135BACKGROUND

  • 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: 31085947BACKGROUND

  • 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: 7614243BACKGROUND

  • 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: 16183200BACKGROUND

  • 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: 27077993BACKGROUND

  • 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: 36360967BACKGROUND

  • 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: 14968274BACKGROUND

  • 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: 36945108BACKGROUND

  • 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: 34446276BACKGROUND

  • 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: 28939426BACKGROUND

  • 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: 20549083BACKGROUND

Related Links

Study Officials

  • Lars Oddsson, PhD

    RxFunction Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Project Manager

CONTACT

6123582141research@rxfunction.com

Senior Clinical Scientist

CONTACT

6123582141research@rxfunction.com

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

June 25, 2026

Record last verified: 2026-02

Locations

US(1)