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NCT Number: NCT07519096

Steady Together Fall Prevention Program in the Home

The purpose of the research study is to assess the efficacy of the occupational therapy Steady Together Fall Prevention Program in the Home for persons with Parkinson's Disease (PwP) who are members of InMotion. InMotion is a community wellness center that offers a variety of programs for PwP. The goal of the program is to prolong safe and independent living of PwP within their homes through fall prevention. Objectives are: 1) to identify areas in the home that are barriers to safe and accessible functioning for PwP with a focus on fall prevention; 2) To recommend assistive equipment, performance strategies, and home modifications as well as helpful resources to enhance safety and accessibility within the home. 3) to improve accessibility of the home; 4) to improve the PwP's safety confidence within their home.

Research questions are:

1. Do participants have improved safety confidence in their homes as relates to falls after completing the program 2. Is home more accessible after completing program 3. What areas of the home pose the most fall risk among this population 4. What types of modifications and assistive devices help to reduce falls among this population 5. Does the program help to reduce falls among this population

Participants will complete an initial intake form (30 minutes); they will participate in a 2 hour home assessment performed by occupational therapists using the Home for Life Design (HfLD platform in which they will be asked to identify areas of their home they have fall safety concerns; they will rate the safety of these spaces; they will demonstrate activities of daily living done in spaces and the occupational therapist will rate accessibility of these spaces; they will participate in a 30 minute meeting with the occupational therapist to review report with recommendations and resources and develop an agreed upon action plan; they will implement action plan; they will participate in a one hour reassessment; participate in a follow up 30 minute phone interview one year later. Total time commitment is 4 hours.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Using the HfLD platform, the OT will work collaboratively with the client and care partner/family member(s) during the delivery of the Steady Together program. The program includes the following (after obtaining informed consent):

  • Initial intake questionnaire. 30 minutes. Participants (members) will be asked to complete an initial online intake survey that will be located on qualtrics.
  • First 2 hour session in home:
  • Interview questions will include questions about fall history, places in the home and/or daily activities that are of concern to the client and/or care partner, and client's relevant medical history. OT will ask the client to identify up to 5 areas/rooms within the home that are of most concern and rank them as most important to address (most important to least important).
  • Rate Personal Safety for each room assessed: For each room identified as of concern, the OT will ask the client to rate their personal safety (Personal Safety Rating- PSR) using a 10 point Likert Scale (0=do not feel safe; 10= feels safe). The HfLD application will automatically convert scaled scores for each room to percentages.
  • For each room identified as of concern, the OT will observe the client perform their typical daily activities within the room to assess the accessibility of each room using the HfLD tool. The OT will use the Accessibility Rating (AR) scale: 0= not accessible; 5= partially accessible; 10=fully accessible (see attached scale). The HfLD application will automatically convert the scaled scores for each room to percentages.
  • During the home assessment, the OT, using clinical expertise, will discuss options with client and care partner, such as assistive equipment, alternative performance strategies, and/or home modifications that can be made to support the client's continued safety and independence at home.
  • Meet with OT to review report via zoom or phone: 30 minutes.
  • The OT will prepare a report using the HfLD platform. Based on the findings and their clinical expertise, the OT report will provide a summary of findings, including Personal Safety Ratings and Accessibility Ratings for each room. It will identify barriers interfering with performance and provide environmental, equipment, or performance strategy recommendations, and useful resources to promote safety and accessibility within the home. The OT will provide client-centered recommendations. The report will include photographs of areas within the various rooms that identify areas of concern allowing the OT to illustrate directly on the photos where equipment should be installed, furniture moved, etc. Photos will not have people in them. The OT will send a link to the report to the client. The client can then download the report if they choose to do so. (See attached report sample).
  • The OT will meet for 30 minutes with the client via zoom or telephone to review the report, answer any questions, and discuss an action plan that is practical for the client.
  • Client will implement agreed upon recommendations within approximately 1-2 months from time of report review. This is done independently or with assistance of care partner/family. Resources will be provided to members to assist them in finding a handyman or community resources that may provide financial assistance or access to assistive equipment.
  • Follow-up re-assessment in home by OT after recommendations are implemented by client: 1 hour The client will need to provide new PSRs for designated rooms and demonstrate performance within rooms again so the OT can reassess accessibility ratings of the specified rooms. The OT will rate overall compliance
  • One year follow-up phone call interview by OT to answer questions about fall experiences/frequencies. 30 minutes.
  • Occupational therapy services provided will fall within the occupational therapy scope of practice of the State of Ohio.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older Parkinson's disease Member of InMotion Care Partner of member Participating in InMotion Fall Prevention program Has completed the MoCA

Exclusion criteria

  • Unable to make own medical decisions

Treatment and study plan

Steady Together at home fall prevention program

Other

Interventions focus on fall prevention in the home for people with Parkinsons disease. Collaborative action plan developed based on initial assessment. Interventions address issues that may be more relevant for this population.

Other names: Recommendations for assistive equipment, Recommendations for home modifications, Recommendations for behavioral changes to prevent falls, Recommendations for strategies to perform activities of daily living to prevent falls, action plan

Primary outcomes

  1. Personal Safety Rating

    Time frame: From initial assessment to reassessment at one month after implementation of action plan

    Participants rate how safe they feel in each room

  2. Accessibility Rating

    Time frame: From initial assessment to reassessment at one month after implementation of action plan

    Rating of accessibility of each room or space in home

  3. Fall frequency

    Time frame: From initial assessment to reassessment at one month after action plan implemented, in addition to one year follow up.

    Number of falls or near falls

Secondary outcomes

  1. Overall safety rating performing daily activities

    Time frame: Ratings are collected one year after interventions are completed.

    One year follow up includes asking participants their overall safety rating performing daily activities on scale of 0-10. This includes asking them to compare if they feel safer doing activities compared on one year ago.

  2. Risk of falling

    Time frame: Information is collected one year after interventions are completed

    Asks participants to report whether they perceive changes in their risk of falling

  3. Overall compliance with action plan

    Time frame: From action plan meeting and implementation of plan to reassessment one month later.

    Rates compliance of participants specific to action plan

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Ekelman, PhD

CONTACT

[email protected]

216-544-3109

Joanna DeMarco, DHSc

CONTACT

[email protected]

216-687-3553

Sponsors and collaborators

Lead sponsor

Cleveland State University

Other

Collaborators

  • Beth A Ekelman, PhD, JD, OTR/L LLC
  • InMotion Wellness Center
  • Mpb Charitable Foundation
  • SLW Therapy Services, LLC

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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