NCT07412145

How's Your Balance?

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: RxFunction Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Balance Assessment
• Falls
• Plantar Sensation

Interventions

Type	Name	Description
OTHER	None AHT	This is an observational study that does not involve any intervention.

Timeline

• Start date: 2025-08-23
• Primary completion: 2028-09-10
• Completion: 2028-12-01
• First posted: 2026-02-17
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States