Parkinson's Trial NCT06573762
Monitor gait and tremor remotely
- Trial ID
- NCT06573762
- Official Title
- Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
- Goal
- Monitor gait and tremor remotely
- Status
- RECRUITING
- Sponsor
- Jacob E. Simmering
- Study Type
- OBSERVATIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease
Summary For Families
The goal is to see if consumer activity trackers plus computer vision can give a holistic, low-cost picture of Parkinson's motor symptoms over time, capturing real-world changes that clinic visits often miss. Participants wear a Fitbit that records steps, activity, sleep and heart rate, and submit short videos that are analyzed by computer vision to quantify tremor, slowness, and gait; combining these objective measures could make symptom tracking more continuous and precise. There is no drug or device treatment here, the study only collects data remotely to evaluate how well these tools reflect Parkinson's signs. They are enrolling people aged 50 to 110 in two groups, either newly referred with possible Parkinson's who have not been previously diagnosed, or clinic patients diagnosed within the past 6 months; exclusions include being bed- or wheelchair-bound, non-English speakers, prisoners, inability to consent, or not having a phone that supports the Fitbit app.
Locations
- University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see if consumer activity trackers plus computer vision can give a holistic, low-cost picture of Parkinson's motor symptoms over time, capturing real-world changes that clinic visits often miss. Participants wear a Fitbit that records steps, activity, sleep and heart rate, and submit short videos that are analyzed by computer vision to quantify tremor, slowness, and gait; combining these objective measures could make symptom tracking more continuous and precise. There is no drug or device treatment here, the study only collects data remotely to evaluate how well these tools reflect Parkinson's signs. They are enrolling people aged 50 to 110 in two groups, either newly referred with possible Parkinson's who have not been previously diagnosed, or clinic patients diagnosed within the past 6 months; exclusions include being bed- or wheelchair-bound, non-English speakers, prisoners, inability to consent, or not having a phone that supports the Fitbit app.
- Who can participate?
- Participants must be between 50 Years and 110 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Participants will have an in-person baseline visit, wear an activity tracker at home for 4 weeks with a video visit at 4 weeks, and some participants will have a one-year in-person research visit.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Wearable / at-home monitoring (non-invasive); Walking & movement tests (non-invasive); Thinking & memory tests (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.