[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07412145":3,"trial-entities:NCT07412145":150,"trial-summary:NCT07412145":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":61,"minimum_age":62,"maximum_age":25,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":72,"locations":75,"central_contacts":93,"overall_officials":96,"references":100,"see_also_links":147},"NCT07412145","CIP 0011","How's Your Balance?","RECRUITING","2028-12","2026-02","2026-06-25","2025-08-23","RxFunction Inc.","INDUSTRY",false,"The goals of this observational study are to investigate the following:\n\n* If there is a relationship between prior falls, single leg stance time, and plantar cutaneous sensitivity as measured by monofilaments.\n* Plantar sensitivity across a broad range of ages.\n* 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).\n\nParticipants 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.","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.\n\nIn 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.\n\nPrimary Research Question\u002FHypothesis 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.\n\nSecondary Research Question(s)\u002FHypothesis\n\n* 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.\n* 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.\n* 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.",[18,19,20],"Balance Assessment","Falls","Plantar Sensation",[22,19,23],"Balance","Plantar sensation","OBSERVATIONAL",null,[],{"count":28,"type":29},1000,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"OTHER","None AHT","This is an observational study that does not involve any intervention.",[36],"State Fair Attendees",[38],{"measure":39,"description":40,"timeFrame":41},"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",[43,46,50,54,57],{"measure":44,"description":45,"timeFrame":41},"Anthropometric Information","We will collect information about the participants: age, sex, race, ethnicity, fall history, diagnosis of prediabetes or diabetes, diagnosis of peripheral neuropathy, etc. No Protected Health Information (PHI) will be collected.",{"measure":47,"description":48,"timeFrame":49},"PROMIS® Physical Function v2.0 PROWalk","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.","About 2-3 minutes of a single 20-minute session",{"measure":51,"description":52,"timeFrame":53},"Activities-specific Balance Confidence Scale-6 (ABC-6)","Powell and Myers developed the 16-item Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in older adults. Schepens et al. (2009) validated a 6-item version of the ABC, using the six most challenging activities from the 16-item scale. The six tasks are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (6). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance.","2-3 minutes of a single 20-minute session",{"measure":55,"description":56,"timeFrame":49},"International Physical Activity Questionnaire (IPAQ)-Short Form","The International Physical Activity Questionnaire (IPAQ) is a standardized self-report instrument used to assess physical activity across populations. It captures time spent walking, performing moderate and vigorous physical activity, and sitting, typically over the previous 7 days. The IPAQ is available in short and long forms; the short form is commonly used for surveillance and prevalence studies. Responses can be scored to estimate total physical activity, often expressed as MET (Metabolic Equivalent of Task)-minutes per week, and to classify activity levels as low, moderate, or high.",{"measure":58,"description":59,"timeFrame":60},"Monofilament Testing","The Centers for Medicare \\& Medicaid Services (CMS) identifies the monofilament test as the means of diagnosing loss of protective sensation (https:\u002F\u002Fwww.cms.gov\u002Fmedicare-coverage-database\u002Fview\u002Fncd.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\u002Fshe feels the filament. 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).","About 2 minutes of a single 20-minute session","ALL","20 Years",true,{"inclusion":65,"exclusion":68,"raw_text":71},[66,67],"Adults, ages 20 and older","Able to provide verbal consent",[69,70],"Individuals, ages 19 and younger","Inability to provide verbal consent","Inclusion Criteria:\n\n* Adults, ages 20 and older\n* Able to provide verbal consent\n\nExclusion Criteria:\n\n* Individuals, ages 19 and younger\n* Inability to provide verbal consent",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":90},"Driven to Discover Research Facility at the Minnesota State Fair","Saint Paul","Minnesota","55108","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Clinical Research Project Manager","CONTACT","6123582141","research@rxfunction.com",{"name":89,"role":85,"phone":86,"email":87},"Senior Clinical Scientist",{"lat":91,"lon":92},44.94441,-93.09327,[94,95],{"name":84,"role":85,"phone":86,"email":87},{"name":89,"role":85,"phone":86,"email":87},[97],{"name":98,"affiliation":12,"role":99},"Lars Oddsson, PhD","PRINCIPAL_INVESTIGATOR",[101,105,108,111,114,117,120,123,126,129,132,135,138,141,144],{"pmid":102,"type":103,"citation":104},"16166466","BACKGROUND","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\u002F0950469.",{"pmid":106,"type":103,"citation":107},"19349593","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\u002Fgerona\u002Fglp033. Epub 2009 Apr 6.",{"pmid":109,"type":103,"citation":110},"35728834","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\u002Fbjsports-2021-105360. Epub 2022 Jun 21.",{"pmid":112,"type":103,"citation":113},"21205966","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\u002Fjama.2010.1923.",{"pmid":115,"type":103,"citation":116},"15069135","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\u002F00004623-200404000-00008.",{"pmid":118,"type":103,"citation":119},"31085947","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\u002FBOT.0000000000001493.",{"pmid":121,"type":103,"citation":122},"7614243","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\u002Fgerona\u002F50a.4.m211.",{"pmid":124,"type":103,"citation":125},"16183200","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\u002Fj.neulet.2005.08.060. Epub 2005 Sep 23.",{"pmid":127,"type":103,"citation":128},"27077993","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\u002F10749357.2016.1162396. Epub 2016 Mar 31.",{"pmid":130,"type":103,"citation":131},"36360967","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\u002Fijerph192114092.",{"pmid":133,"type":103,"citation":134},"14968274","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\u002Fs00221-003-1804-y. Epub 2004 Feb 14.",{"pmid":136,"type":103,"citation":137},"36945108","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\u002Fjgs.18338. Epub 2023 Mar 21.",{"pmid":139,"type":103,"citation":140},"34446276","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\u002Fj.maturitas.2021.06.007. Epub 2021 Jun 24.",{"pmid":142,"type":103,"citation":143},"28939426","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\u002Fj.apmr.2017.08.480. Epub 2017 Sep 20.",{"pmid":145,"type":103,"citation":146},"20549083","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\u002FS1808-86942010000200012.",[148],{"label":77,"url":149},"https:\u002F\u002Fd2d.umn.edu\u002F",{"nct_id":4,"conditions":151,"biomarkers":154},[152,153],"Fall","Impaired Balance",[],{"nct_id":4,"found":63,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is an observational study, meaning there are no interventions or treatments. It aims to enroll 1000 participants.","completed","Observational Study: How's Your Balance?","This observational study, called \"How's Your Balance?\", is looking at how balance is related to past falls and the feeling in the bottom of your feet (plantar sensation). Researchers also want to understand how foot sensation changes with age and how people describe their own balance and movement. You would answer questions about your balance and falls, have the sensation in your feet tested with monofilaments (small, flexible wires), and stand on a special plate with your eyes open and closed for a short time. The study aims to enroll 1000 adults, aged 20 and older, who can give verbal consent. The main goal is to measure your balance using dual- and single-leg standing tests during a single 20-minute session.","Not specified.",120,"You would participate in a single 20-minute session. During this session, you will answer questions, have your foot sensation tested, and perform standing balance tests.","Not stated in the trial record.",[],"v2"]