Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07092176

Randomized Controlled Study Comparing the Physiatry-Based Steady Strides Fall Prevention Protocol to Standard Primary Care in Community-Dwelling Older Adults

Led by Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute · Updated on 2026-04-29

102

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Falls are a major cause of preventable injury and death among community-dwelling older adults aged 65 and older in the US. The trial evaluates the effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard care provided by primary care providers. The study aims to reduce falls and related complications by focusing on functional and biomechanical factors that contribute to fall risk, involving a multidisciplinary approach led by specialists trained in functional medicine and rehabilitation. Participants are randomly assigned to one of two groups: the Steady Strides intervention or standard care. The Steady Strides group receives a multifactorial program led by physiatrists and rehabilitation therapists trained in the protocol, combining medical and rehabilitation interventions. The control group receives usual care coordinated by their primary care provider, including evaluation and management according to CDC's STEADI guidelines. Assessments occur at baseline, 2 months, and follow-ups up to 8 months. Participants will be involved in evaluations including physical and cognitive assessments, fall risk and fear of falling measures, functional reach tests, frailty and emotional wellbeing assessments, and monitoring of fall-related hospitalizations and healthcare use. Data are collected at baseline, during intervention completion at 2 months, and monthly up to 8 months. The primary outcome is the total number of falls six months after completing the intervention. Safety and side effects are also tracked throughout the study duration.

CONDITIONS

Brief Title

Steady Stride Fall Prevention Protocol vs Standard of Care

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be community-dwelling adults aged 65 years or older.
  • Participants must have experienced at least two falls in the six months before the intake visit.
  • Participants must be able to drive independently at the time of intake.
  • Participants must be able to walk at least 10 feet with or without an assistive device (wheelchair users are excluded).
  • Participants must be able to independently make medical decisions and provide consent.
  • Participants must live in a community setting, not in a hospital or long-term care facility.
  • Participants must be able to speak, read, and understand English fluently.
Not Eligible

You will not qualify if you...

  • No additional exclusion criteria beyond those specified in the inclusion criteria; all who meet inclusion criteria are eligible.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 months

Participants receive either the structured physiatrist-led Steady Strides Fall Prevention Protocol involving multifactorial interventions by trained providers or standard care managed by primary care providers following CDC's STEADI guidelines.

1 baseline visit and 1 follow-up visit at 2 months

Follow-up

Duration - 6 months

Participants are monitored for falls, fall-related morbidity, healthcare utilization, and other health outcomes after completion of the intervention.

Monthly visits or contacts for up to 6 months after treatment

Trial Site Locations

Total: 1 location

1

Steady Strides

Baltimore, Maryland, United States, 21215

Actively Recruiting

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Research Team

L

Levan Atanelov, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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.

https://pubmed.ncbi.nlm.nih.gov/11380764

Implementation of the Stopping Elderly Accidents, Deaths, and Injuries Initiative in Primary Care: An Outcome Evaluation.

Yvonne A Johnston, Gwen Bergen, Michael Bauer...

https://pubmed.ncbi.nlm.nih.gov/30239774

Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis.

Andrea C Tricco, Sonia M Thomas, Areti Angeliki Veroniki...

https://pubmed.ncbi.nlm.nih.gov/29114830

Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Janelle M Guirguis-Blake, Yvonne L Michael, Leslie A Perdue...

https://pubmed.ncbi.nlm.nih.gov/29710140