Recruiting

Steady Strides vs. Standard Care

Sponsor:

Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute

Code:

NCT07092176

Conditions

Fall Prevention

Falls

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Steady Strides

Study Details

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

Study ID

NCT07092176

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: Steady Strides

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

Interventions

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 measure

  • Falls [ Time Frame: Total falls reported after completion of the intervention 6 months after the intervention. ]

Central Contacts and Locations

Central contacts

Locations

Steady Strides

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Principal Investigator:

Levan Atanelov, MD

More Information

Sponsor

Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Falls
  • Fall Risk
  • Physiatry
  • Physical Therapy
  • Occupational Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Steady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute on 2026-04-29.