Balance Assessment, Falls, Plantar Sensation
Conditions
Keywords
Balance, Falls, Plantar sensation
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.
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.
Interventions
OTHERNone AHT
This is an observational study that does not involve any intervention.
Sponsors
RxFunction Inc.
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults, ages 21 and older * Able to provide verbal consent
Exclusion criteria
* Individuals, ages 20 and younger * Inability to provide verbal consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monofilament Testing | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS® Physical Function v2.0 PROWalk | 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. |
| Demographic Information | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLars Oddsson, PhD
RxFunction Inc.
Outcome results
None listed