PARKINSON DISEASE (Disorder)NCT07519096
Steady Together Fall Prevention Program in the Home
A study testing Steady Together at home fall prevention program in people with PARKINSON DISEASE (Disorder), run by Cleveland State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Steady Together at home fall prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older Parkinson's disease Member of InMotion Care Partner of member Participating in InMotion Fall Prevention program Has completed the MoCA
Who cannot join
- Unable to make own medical decisions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
InMotion Wellness Center
Beachwood, Ohio, 44122
Cathe Schwartz, 216-342-4417, cschwartz@beinmotion.org
Ben Rossi, 216-342-4417, brossi@beinmotion.org
About this study
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:
Read more
- Do participants have improved safety confidence in their homes as relates to falls after completing the program
- Is home more accessible after completing program
- What areas of the home pose the most fall risk among this population
- What types of modifications and assistive devices help to reduce falls among this population
- 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.
Read the detailed description
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Steady Together at home fall prevention program
- Keywords
- Fall Prevention, Home Safety
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steady Together at home fall prevention programOther
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Steady Together Fall Prevention Program in the Home | Other | Not described Receives: Other: Steady Together at home fall prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Safety Rating
Participants rate how safe they feel in each room
Measured: 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
Measured: From initial assessment to reassessment at one month after implementation of action plan
Fall frequency
Number of falls or near falls
Measured: 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
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.
Measured: Ratings are collected one year after interventions are completed.
Risk of falling
Asks participants to report whether they perceive changes in their risk of falling
Measured: Information is collected one year after interventions are completed
Overall compliance with action plan
Rates compliance of participants specific to action plan
Measured: From action plan meeting and implementation of plan to reassessment one month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start6 Apr 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mpb Charitable Foundation, InMotion Wellness Center, Beth A Ekelman, PhD, JD, OTR/L LLC, SLW Therapy Services, LLC
- Responsible party
- Principal investigator, Joanna DeMarco, Cleveland State University
- Investigators
- Joanna DeMarco, DHSc, Principal investigator, Cleveland State UniversityStephen Slane, PhD, Study director, Cleveland State UniversityBeth Ekelman, PhD, Study director, Cleveland State University and Beth A Ekelman, PhD, JD, OTR/L LLCSusan Wayne, MEd, Study director, SLW Therapy Services, LLCCathe Schwartz, Study director, InMotion Orthopaedic Research CenterBen Rossi, ACE-CPT, Study director, InMotion Orthopaedic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519096
- Sponsor's protocol ID
- IRB-FY2026-20
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steady Together Fall Prevention Program in the Home
- ClinicalTrials.gov ID
- NCT07519096
- Acronym / sponsor ID
- IRB-FY2026-20
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Fall Prevention, Home Safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cleveland State UniversityUniversity, hospital or other
- Collaborators
- Mpb Charitable Foundation, InMotion Wellness Center, Beth A Ekelman, PhD, JD, OTR/L LLC, SLW Therapy Services, LLC
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do participants have improved safety confidence in their homes as relates to falls after completing the program
- Is home more accessible after completing program
- What areas of the home pose the most fall risk among this population
- What types of modifications and assistive devices help to reduce falls among this population
- 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Steady Together Fall Prevention Program in the Home | Other | Other: Steady Together at home fall prevention program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older Parkinson's disease Member of InMotion Care Partner of member Participating in InMotion Fall Prevention program Has completed the MoCA
Key exclusion criteria (1 listed)
- Unable to make own medical decisions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steady Together at home fall prevention programAlso: 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 fallsInterventions 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 | Steady Together Fall Prevention Program in the Home |
Primary outcome
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
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
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
3 secondary outcomes
Overall safety rating performing daily activities
Time frame: Ratings are collected one year after interventions are completed.
Risk of falling
Time frame: Information is collected one year after interventions are completed
Overall compliance with action plan
Time frame: From action plan meeting and implementation of plan to reassessment one month later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- InMotion program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna DeMarco, DHSc principal investigator
Cleveland State University
Stephen Slane, PhD study director
Cleveland State University
Beth Ekelman, PhD study director
Cleveland State University and Beth A Ekelman, PhD, JD, OTR/L LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steady Together at home fall prevention program in people with PARKINSON DISEASE (Disorder), run by Cleveland State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna DeMarco, DHSc (216-687-3553, j.l.reid@csuohio.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Safety Rating (time frame: From initial assessment to reassessment at one month after implementation of action plan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.