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Идёт набор NCT07412145

How's Your Balance?

Наблюдательное Balance Assessment Falls Plantar Sensation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: None AHT.
Кому может быть актуально
Состояния в реестре: Balance Assessment, Falls, Plantar Sensation. Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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, single leg 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.

Primary Research Question/Hypothesis What is the relationship between physiological aging and Romberg ratio values during standing balance, and how well can age and somatosensory function explain variation in Romberg ratio values? We hypothesize that older age and reduced somatosensory function will be associated with higher Romberg ratio values (i.e., stronger dependence on vision, suggestive of somatosensory deficits) during standing balance.

Secondary Research Question(s)/Hypothesis

* To what extent does plantar cutaneous sensitivity at different foot sites relate to Romberg ratio values during standing balance, and which site(s) remain significant predictors after controlling for age? We believe that reduced plantar cutaneous sensitivity (higher monofilament thresholds) at medial foot sites will be associated with higher Romberg ratio values, independent of age. * How are standing Romberg ratio values related to self-reported physical function (PROMIS® PROWalk™) and balance confidence (ABC-6) across different ages? We hypothesize that self-reported physical function and balance confidence will be significant predictors of standing Romberg ratio values, such that lower PROMIS® PROWalk™ scores and lower ABC-6 scores are associated with higher Romberg ratio values, independent of age. * We will continue to evaluate whether the threshold for loss of balance sensation is lower than that for loss of protective sensation (i.e., inability to feel a 10g monofilament at 2 of 5 sites on the plantar surface of the foot). We hypothesize that impaired balance will be associated with reduced or absent plantar cutaneous sensation, regardless of age.

Вмешательства

  • Другое None AHT
    This is an observational study that does not involve any intervention.

Первичные конечные точки

  • Dual- and Single-Leg Quiet Standing Tests [Срок оценки: About 4-5 minutes of a single 20-minute session]
Вторичные конечные точки (5)
  • Anthropometric Information [Срок оценки: About 4-5 minutes of a single 20-minute session]
  • PROMIS® Physical Function v2.0 PROWalk [Срок оценки: About 2-3 minutes of a single 20-minute session]
  • Activities-specific Balance Confidence Scale-6 (ABC-6) [Срок оценки: 2-3 minutes of a single 20-minute session]
  • International Physical Activity Questionnaire (IPAQ)-Short Form [Срок оценки: About 2-3 minutes of a single 20-minute session]
  • Monofilament Testing [Срок оценки: About 2 minutes of a single 20-minute session]

Критерии участия

Критерии включения

  • Adults, ages 20 and older
  • Able to provide verbal consent

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

США · 1 центр
  • Driven to Discover Research Facility at the Minnesota State Fair — Saint Paul

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT07412145 · CIP 0011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗