Steady Stride Fall Prevention Protocol vs Standard of Care

NCT07092176 | Recruiting DMC

• 1 other identifier: SSRCT1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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 provided by primary care providers in preventing falls in community-dwelling older adults.

Conditions

Fall Prevention; Falls

Keywords

Falls; Fall Risk; Physiatry; Physical Therapy; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Falls

  The primary outcome is self-reported total number of falls during the 6 months of the follow up period after the 2 month intervention. Values 0-100. Lower number are better functioning. Falls were defined as "unintentionally coming to the ground or some lower level and other than as a consequence of sustaining a violent blow, loss of consciousness, sudden onset of paralysis as in stroke or an epileptic seizure."

  Total falls reported after completion of the intervention 6 months after the intervention.

Secondary Outcomes (17)

• Fall-Related Morbidity-number of hospitalizations or ED visits

  assessed monthly at months 1-8

• Fall Risk

  Assessed at the completion of the intervention (2 months after the first visit)

• Fall-Related Healthcare Utilization

  baseline and monthly for 8 months

• Fear of Falls

  Assessed at the completion of the intervention (2 months after the first visit)

• iADLs

  Assessed at the completion of the intervention (2 months after the first visit)

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Steady Strides

EXPERIMENTAL

Steady Strides Fall Prevention Protocol. See below for more detail.

Other: Steady Strides

Interventions

Steady Strides OTHER

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

Steady Strides

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: Participants must be community-dwelling older adults aged 65 years or older.
• 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.

Sponsors & Collaborators

• Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute: lead

Study Sites (1)

Steady Strides

Baltimore, Maryland, 21215, United States

RECRUITING

Related Publications (24)

• 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.

  PMID: 33921355 BACKGROUND

• 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.

  PMID: 37651272 BACKGROUND

• 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.

  PMID: 11380764 BACKGROUND

• 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.

  PMID: 3595217 BACKGROUND

• 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.

  PMID: 25700584 BACKGROUND

• 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.

  PMID: 31903086 BACKGROUND

• 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.

  PMID: 30239774 BACKGROUND

• 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.

  PMID: 29114830 BACKGROUND

• 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.

  PMID: 22972103 BACKGROUND

• 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.

  PMID: 29710140 BACKGROUND

• 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.

  PMID: 32074420 BACKGROUND

• 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.

  PMID: 27858951 BACKGROUND

• 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.

  PMID: 32951215 BACKGROUND

• 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.

  PMID: 37107780 BACKGROUND

• 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.

  PMID: 30571419 BACKGROUND

• 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.

  PMID: 28440888 BACKGROUND

• 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.

  PMID: 34844015 BACKGROUND

• 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.

  PMID: 35509040 BACKGROUND

• 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.

  PMID: 21045097 BACKGROUND

• 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.

  PMID: 12180240 BACKGROUND

• 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.

  PMID: 23581923 BACKGROUND

• 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.

  PMID: 26795891 BACKGROUND

• 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.

  PMID: 8286498 BACKGROUND

• 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.

  PMID: 16926210 BACKGROUND

Related Links

• 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

Central Study Contacts

Levan Atanelov, MD

CONTACT

(443) 898-8160; hello@steadystridesmd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Baseline assessment is masked, and outcomes assessment is if not fully, at least partially masked. Full masking can't be ensured for outcomes assessor and care providers as participants are not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO and Practice Owner

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: July 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)