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临床试验/NCT07412145
NCT07412145
进行中(未招募)
不适用

How's Your Balance?

RxFunction Inc.1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年8月23日最近更新:
干预措施None AHT

概览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Monofilament Testing

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

State Fair Attendees

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

干预措施: None AHT (Other)

结局指标

主要结局

Monofilament Testing

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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