Parkinson DiseaseNCT05655377
FitMi PD Home Therapy for Parkinson's Disease
A study testing FitMi PD in people with Parkinson Disease, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
Trial summary
The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- FitMi PD
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- mild to moderate PD (Hoehn and Yahr stage I to III)
- Mini-Mental State Examination greater than 28
Who cannot join
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease
The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.
- Conditions
- Parkinson Disease
- Being tested
- FitMi PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitMi PDDevice
Exercise using the motion sensing devices and a tablet computer
| Study group | Role | What they receive |
|---|---|---|
| At home exercise therapy with FitMi PD | Experimental | Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. Receives: Device: FitMi PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Successfully Used FitMi PD to Exercise at Home
Number of participants who were successfully able to use the device at home to exercise over 3 week period.
Measured: Immediately Post-Treatment, an average of 3 weeks
Secondary outcomes (1)
Mini Mental State Examination (MMSE)
A screening tool for assessing cognitive impairment. A maximum possible score of 30 is used to provide a picture of an individuals' present cognitive performance. A score of < 24 is the generally accepted cutoff indicating the presence of cognitive impairment.
Levels of impairment have been classified as:
None: score = 24-30 Mild: score = 18-24 Severe: score = 0-17
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Mar 2021
- Primary completion15 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655377
- Sponsor's protocol ID
- 1R43AG071253-01
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2022
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05655377
- Acronym / sponsor ID
- 1R43AG071253-01
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At home exercise therapy with FitMi PD | Experimental | Device: FitMi PDParticipants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild to moderate PD (Hoehn and Yahr stage I to III)
- Mini-Mental State Examination greater than 28
Key exclusion criteria (1 listed)
- Age less than 18 years old
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 |
|---|---|---|
| FitMi PDExercise using the motion sensing devices and a tablet computer | Device | At home exercise therapy with FitMi PD |
Primary outcome
Number of Participants That Successfully Used FitMi PD to Exercise at Home
Time frame: Immediately Post-Treatment, an average of 3 weeks
Number of participants who were successfully able to use the device at home to exercise over 3 week period.
1 secondary outcome
Mini Mental State Examination (MMSE)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitMi PD in people with Parkinson Disease, run by Flint Rehabilitation Devices, LLC 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 2 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: finished, as of the sponsor's last update on 17 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Successfully Used FitMi PD to Exercise at Home (time frame: Immediately Post-Treatment, an average of 3 weeks). 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 17 Feb 2023.