NCT07092176 · Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute
Steady Stride Fall Prevention Protocol vs Standard of Care
(SteadyStrides)
What this study is about
Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) .
View original scientific description
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.
Interventions
OTHER
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
Primary outcome measures
Falls
Time frame: Total falls reported after completion of the intervention 6 months after the intervention.
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."
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- No additional exclusion criteria beyond those specified in the inclusion criteria. All individuals who meet the inclusion criteria are eligible to participate in the study.
Where
- Baltimore, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations