NCT07519096

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026May 2028

First Submitted

Initial submission to the registry

April 2, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

Fall PreventionHome Safety

Outcome Measures

Primary Outcomes (3)

  • Personal Safety Rating

    Participants rate how safe they feel in each room

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

  • Accessibility Rating

    Rating of accessibility of each room or space in home

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

  • Fall frequency

    Number of falls or near falls

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

Secondary Outcomes (3)

  • Overall safety rating performing daily activities

    Ratings are collected one year after interventions are completed.

  • Risk of falling

    Information is collected one year after interventions are completed

  • Overall compliance with action plan

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

Study Arms (1)

Steady Together Fall Prevention Program in the Home

OTHER
Other: Steady Together at home fall prevention program

Interventions

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.

Also known as: 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
Steady Together Fall Prevention Program in the Home

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to make own medical decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InMotion Wellness Center

Beachwood, Ohio, 44122, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Self-Help Devices

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Joanna DeMarco, DHSc

    Cleveland State University

    PRINCIPAL INVESTIGATOR
  • Stephen Slane, PhD

    Cleveland State University

    STUDY DIRECTOR
  • Beth Ekelman, PhD

    Cleveland State University and Beth A Ekelman, PhD, JD, OTR/L LLC

    STUDY DIRECTOR
  • Susan Wayne, MEd

    SLW Therapy Services, LLC

    STUDY DIRECTOR
  • Cathe Schwartz

    InMotion Orthopaedic Research Center

    STUDY DIRECTOR
  • Ben Rossi, ACE-CPT

    InMotion Orthopaedic Research Center

    STUDY DIRECTOR

Central Study Contacts

Joanna DeMarco, DHSc

CONTACT

Beth Ekelman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Participants are members of InMotion, a community wellness center for persons with Parkinson's Disease. They will participate in a fall prevention home program that has 4 main phases: initial assessment, action plan and implementation of plan, reassessment, and a one year follow up interview.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor, Department Chair

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

All data reported will be deidentified. Only participants and occupational therapists providing intervention will have access to individualized data. This is required to adhere to HIPAA.

Locations