Steady Stride Fall Prevention Protocol vs Standard of Care
NCT ID: NCT07092176
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-10-15
2029-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fall Recovery Training for Older Adults in Continuous Care Facilities
NCT02173015
A Trial of an Improved Fall Risk Assessment and Activity Test to Prevent Falls in Elderly Inpatients
NCT07126925
Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program
NCT00187317
A Community-Based Falls Prevention Program for Adults At-Risk for Falls
NCT05771818
Stroll Safe Outdoor Fall Prevention Program
NCT02946593
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Rationale/Significance/Problem Statement
2.1 Rationale While the role of primary care providers in managing falls in older adults is crucial, investigators believe that fall prevention should primarily be managed by physicians trained in functional medicine, given that "medical reasons" are not the most common causes of falls. For example, one commonly thought of "medical reason" for falls, syncope, accounts for no more than 5% of falls in this population . Similarly, there is no strong association between falls and urinary tract infection, another commonly considered "medical reason" for falls in the elderly population. Whereas, by some estimates "mechanical falls," a term often used for "non-medical" causes, represent over 62% of falls among older adults presenting to emergency departments. Frequently reported causes of falls include slips, trips, and loss of balance, while factors often associated with falls include poor balance and difficulties with activities of daily living. Systematic reviews have consistently shown that functional, multifactorial interventions-such as exercise and environmental assessment and modification-are effective in preventing falls . It has been described that functional deficits, which serve as the final common pathway for various medical conditions, frequently constitute the majority of chronic predisposing risk factors for falls. These predisposing factors, such as gait and balance deficits, impaired vision, orthostatic hypotension, and impairments in cognitive function, Activity of Daily Living (ADLs), and Instrumental Activity of Daily Living (iADLs ), often play a significant role in increasing fall risk, with gait and balance problems frequently being the primary contributors. It therefore appears that functional deficits making up the final common pathway for different medical conditions often comprise the bulk of the chronic predisposing fall risk factors for falls . Given the strong evidence supporting functional medicine in fall prevention and the complexity of the neurological systems involved in balance and gait control , a biomechanical and functional assessment and treatment approach is preferred for managing older patients at risk of falls. Therefore, investigators advocate for a physiatrist-based approach for older adults at risk, as physiatrists specialize in functional medicine and the management of biomechanical impairments that affect human function, bridging functional and traditional medical approaches. Steady Strides is a structured, physiatrist-led, multifactorial functional assessment and management intervention. It combines a biomechanics-based functional physiatrist approach with comprehensive orthopedic, vestibular, podiatric, psychological, and neurological assessments to identify and treat the specific underlying biomechanical conditions that increase the risk of falls in older adults.
2.2 Significance Steady Strides protocol efficacy was demonstrated in a retrospective chart review observational cohort study , but there are no previously published physiatry-based randomized controlled studies of structured fall prevention interventions. This is the first structured physiatry-based randomized controlled study for preventing falls in community dwelling older adults.
3. Study Purpose and Objectives 3.1 Purpose Aim: Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) . This is a research study to evaluate the comparative effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard of care treatment in preventing falls in community-dwelling older adults. Current standard of care is for the primary care physicians to evaluate patients at risk of falls, order medical work up, specialist physician consultation(s), medication changes and other interventions as needed, and prescribe physical and/or occupational therapy. Widely publicized guidelines for primary care physicians managing older adults at risk of falls include the American Geriatrics Society and/or the Center for Disease Control and Prevention Stopping Elderly Accidents Deaths and Injuries (STEADI) guidelines. The intervention arm of the Steady Strides Protocol includes both standard care, that is follow up with the primary care and a structured physiatrist-led fall prevention program administered by licensed physical and occupational therapist providers with additional certification in utilizing the Steady Strides Fall Prevention Protocol. Physiatrist and therapist providers are trained using standardized hybrid in-person and online educational materials available at www.steadystridesacademy.com. This training is to standardize education and delivery of service of the Steady Strides Fall Prevention Protocol. Steady Strides Fall Prevention Protocol is not an experimental treatment and preliminary evidence from observational study with the protocol has shown good clinical outcomes.
3.2 Hypothesis: investigators hypothesize that participation in Steady Strides Fall Prevention Program will significantly reduce the number of falls compared to management by primary care providers as per standard of care.
3.3 Objectives
Primary Objective:
To evaluate the effectiveness of the Steady Strides protocol in reducing falls among community dwelling older adults six months after the intervention, specifically targeting individuals who have reported at least two falls in the previous six months.
Secondary Objectives: To evaluate the impact of the intervention on fall-related morbidity and mortality, the rate of hospitalizations, emergency department (ED) visits and other health-care utilization. To assess the impact of the intervention on reduction in fall rates from baseline; fall risk, ADLs, frailty, fear of falls, community integration, cognitive function, sleep and emotional well-being.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
Participants in the control arm will receive a one-time assessment by a trained research assistant at baseline and once more at 2 month follow up. Research assistant will measure and document the specified demographic and clinical variables to be compared between the control and intervention groups.
The usual care will be provided as per the primary care provider's discretion. Providers will be advised to complete the CDC's STEADI (Stopping Elderly Accidents, Deaths, and Injuries) tool via CDC's training portal.
No interventions assigned to this group
Steady Strides
Steady Strides Fall Prevention Protocol. See below for more detail.
Steady Strides
Participants in the control arm will receive a one-time assessment by a trained research assistant at baseline and once more at 2 month follow up. Research assistant will measure and document the specified demographic and clinical variables to be compared between the control and intervention groups.
Participants in the intervention arm will receive a multifactorial intervention, including: Medical Intervention: Provided by physician(s) and/or nurse practitioners (NPs) or physician assistants (PAs) trained in the Steady Strides fall prevention protocol via the hybrid online and in person course on the Steady Strides fall prevention protocol . Rehabilitation Intervention: Provided by occupational therapists (OTs) and physical therapists (PTs) trained through a hybrid online and in person course on the Steady Strides fall prevention protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Steady Strides
Participants in the control arm will receive a one-time assessment by a trained research assistant at baseline and once more at 2 month follow up. Research assistant will measure and document the specified demographic and clinical variables to be compared between the control and intervention groups.
Participants in the intervention arm will receive a multifactorial intervention, including: Medical Intervention: Provided by physician(s) and/or nurse practitioners (NPs) or physician assistants (PAs) trained in the Steady Strides fall prevention protocol via the hybrid online and in person course on the Steady Strides fall prevention protocol . Rehabilitation Intervention: Provided by occupational therapists (OTs) and physical therapists (PTs) trained through a hybrid online and in person course on the Steady Strides fall prevention protocol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Fall History: Participants must have reported experiencing at least two falls in the six months prior to the intake visit.
Independence: Participants must report the ability to drive independently at the time of the intake visit and ambulate at least 10 feet with or without an assistive device (e.g. cane or walker, wheelchair ambulators are not included). Participants must report their ability to independently make medical decisions and sign their medical paperwork, including consent to participate in the study.
Setting: Participants must reside in a community setting, not in a long-term care facility or hospital.
Language: Participants must report ability to speak, read and comprehend English fluently.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Levan Atanelov
CEO and Practice Owner
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Steady Strides
Owings Mills, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ha VT, Nguyen TN, Nguyen TX, Nguyen HTT, Nguyen TTH, Nguyen AT, Pham T, Vu HTT. Prevalence and Factors Associated with Falls among Older Outpatients. Int J Environ Res Public Health. 2021 Apr 12;18(8):4041. doi: 10.3390/ijerph18084041.
Kakara R, Bergen G, Burns E, Stevens M. Nonfatal and Fatal Falls Among Adults Aged >/=65 Years - United States, 2020-2021. MMWR Morb Mortal Wkly Rep. 2023 Sep 1;72(35):938-943. doi: 10.15585/mmwr.mm7235a1.
Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
The prevention of falls in later life. A report of the Kellogg International Work Group on the Prevention of Falls by the Elderly. Dan Med Bull. 1987 Apr;34 Suppl 4:1-24.
Phelan EA, Mahoney JE, Voit JC, Stevens JA. Assessment and management of fall risk in primary care settings. Med Clin North Am. 2015 Mar;99(2):281-93. doi: 10.1016/j.mcna.2014.11.004.
Stevens JA, Smith ML, Parker EM, Jiang L, Floyd FD. Implementing a Clinically Based Fall Prevention Program. Am J Lifestyle Med. 2017 Jul 5;14(1):71-77. doi: 10.1177/1559827617716085. eCollection 2020 Jan-Feb.
Johnston YA, Bergen G, Bauer M, Parker EM, Wentworth L, McFadden M, Reome C, Garnett M. Implementation of the Stopping Elderly Accidents, Deaths, and Injuries Initiative in Primary Care: An Outcome Evaluation. Gerontologist. 2019 Nov 16;59(6):1182-1191. doi: 10.1093/geront/gny101.
Tricco AC, Thomas SM, Veroniki AA, Hamid JS, Cogo E, Strifler L, Khan PA, Robson R, Sibley KM, MacDonald H, Riva JJ, Thavorn K, Wilson C, Holroyd-Leduc J, Kerr GD, Feldman F, Majumdar SR, Jaglal SB, Hui W, Straus SE. Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis. JAMA. 2017 Nov 7;318(17):1687-1699. doi: 10.1001/jama.2017.15006.
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
Guirguis-Blake JM, Michael YL, Perdue LA, Coppola EL, Beil TL. Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Apr 24;319(16):1705-1716. doi: 10.1001/jama.2017.21962.
Ganz DA, Latham NK. Prevention of Falls in Community-Dwelling Older Adults. N Engl J Med. 2020 Feb 20;382(8):734-743. doi: 10.1056/NEJMcp1903252. No abstract available.
Chu MM, Fong KN, Lit AC, Rainer TH, Cheng SW, Au FL, Fung HK, Wong CM, Tong HK. An Occupational Therapy Fall Reduction Home Visit Program for Community-Dwelling Older Adults in Hong Kong After an Emergency Department Visit for a Fall. J Am Geriatr Soc. 2017 Feb;65(2):364-372. doi: 10.1111/jgs.14527. Epub 2016 Nov 17.
Liu M, Xue QL, Gitlin LN, Wolff JL, Guralnik J, Leff B, Szanton SL. Disability Prevention Program Improves Life-Space and Falls Efficacy: A Randomized Controlled Trial. J Am Geriatr Soc. 2021 Jan;69(1):85-90. doi: 10.1111/jgs.16808. Epub 2020 Sep 20.
Nascimento MM, Maduro PA, Rios PMB, Nascimento LDS, Silva CN, Kliegel M, Ihle A. The Effects of 12-Week Dual-Task Physical-Cognitive Training on Gait, Balance, Lower Extremity Muscle Strength, and Cognition in Older Adult Women: A Randomized Study. Int J Environ Res Public Health. 2023 Apr 13;20(8):5498. doi: 10.3390/ijerph20085498.
Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.
Strouwen C, Molenaar EALM, Munks L, Keus SHJ, Zijlmans JCM, Vandenberghe W, Bloem BR, Nieuwboer A. Training dual tasks together or apart in Parkinson's disease: Results from the DUALITY trial. Mov Disord. 2017 Aug;32(8):1201-1210. doi: 10.1002/mds.27014. Epub 2017 Apr 25.
Gambaro E, Gramaglia C, Azzolina D, Campani D, Molin AD, Zeppegno P. The complex associations between late life depression, fear of falling and risk of falls. A systematic review and meta-analysis. Ageing Res Rev. 2022 Jan;73:101532. doi: 10.1016/j.arr.2021.101532. Epub 2021 Nov 27.
Asai T, Oshima K, Fukumoto Y, Yonezawa Y, Matsuo A, Misu S. The association between fear of falling and occurrence of falls: a one-year cohort study. BMC Geriatr. 2022 May 5;22(1):393. doi: 10.1186/s12877-022-03018-2.
Dykes PC, Carroll DL, Hurley A, Lipsitz S, Benoit A, Chang F, Meltzer S, Tsurikova R, Zuyov L, Middleton B. Fall prevention in acute care hospitals: a randomized trial. JAMA. 2010 Nov 3;304(17):1912-8. doi: 10.1001/jama.2010.1567.
Rubenstein LZ, Josephson KR. The epidemiology of falls and syncope. Clin Geriatr Med. 2002 May;18(2):141-58. doi: 10.1016/s0749-0690(02)00002-2.
Rowe T, Towle V, Van Ness PH, Juthani-Mehta M. Lack of positive association between falls and bacteriuria plus pyuria in older nursing home residents. J Am Geriatr Soc. 2013 Apr;61(4):653-4. doi: 10.1111/jgs.12177. No abstract available.
Sri-on J, Tirrell GP, Lipsitz LA, Liu SW. Is there such a thing as a mechanical fall? Am J Emerg Med. 2016 Mar;34(3):582-5. doi: 10.1016/j.ajem.2015.12.009. Epub 2015 Dec 12.
Lord SR, Ward JA, Williams P, Anstey KJ. An epidemiological study of falls in older community-dwelling women: the Randwick falls and fractures study. Aust J Public Health. 1993 Sep;17(3):240-5. doi: 10.1111/j.1753-6405.1993.tb00143.x.
Horak FB. Postural orientation and equilibrium: what do we need to know about neural control of balance to prevent falls? Age Ageing. 2006 Sep;35 Suppl 2:ii7-ii11. doi: 10.1093/ageing/afl077.
Related Links
Access external resources that provide additional context or updates about the study.
Centers for Disease Control and Prevention. STEADI: Provider Training \& Continuing Education
Aaron David Abrishami, Aviel Hanasab, Eliot Sadik, et al. Efficacy of Steady Strides: A Structured Physiatrist-Led Intervention for Reducing Falls in High-Risk Ambulatory Community Dwelling Older Adults: An Observational Cohort Study. . J Med - Clin Res
Centers for Medicare \& Medicaid Services (CMS). Medicare wellness visits
Centers for Disease Control and Prevention. Algorithm for Fall Risk Screening, Assessment, and Intervention. Centers for Disease Control and Prevention 2012
Atanelov L. Steady Strides Fall Prevention Training Course. 2025
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SSRCT1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.