Detect subtle walking changes early
- Trial ID
- NCT06907589
- Official Title
- A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care
- Goal
- Detect subtle walking changes early
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study Type
- INTERVENTIONAL
- Enrollment
- 250 participants
- Conditions
- Parkinson Disease, Healthy Adult
- Interventions
- Motor Data Analysis
Summary For Families
Aims to make Parkinson's easier to catch early and to follow over time by providing an accessible, tech-based way to measure motor signs and keep care continuous. It uses technology to record and analyze motor tasks like walking and other movements, turning those recordings into objective movement metrics that can flag subtle Parkinson's signs and show how symptoms change with medication. The trial seeks adults 50 to 80 years old, either healthy volunteers or people with Parkinson's at Hoehn and Yahr stages 1,3 who can walk without a cane and have an MMSE of 24 or higher. Parkinson's participants are examined while ON their usual medication and should not have dyskinesias or need walking aids.
Locations
- Ospedale Santa Maria Annunziata AUSL Toscana Centro, Bagno a Ripoli, Firenze, Italy
- Azienda Ospedaliero Universitaria Careggi, Florence, Italy
- IRCCS Fondazione Don Carlo Gnocchi Firenze, Florence, Italy
- Ospedale Apuane AUSL Toscana Nord Ovest, Massa, Italy
- IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Milan, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Motor Data Analysis. Aims to make Parkinson's easier to catch early and to follow over time by providing an accessible, tech-based way to measure motor signs and keep care continuous. It uses technology to record and analyze motor tasks like walking and other movements, turning those recordings into objective movement metrics that can flag subtle Parkinson's signs and show how symptoms change with medication. The trial seeks adults 50 to 80 years old, either healthy volunteers or people with Parkinson's at Hoehn and Yahr stages 1,3 who can walk without a cane and have an MMSE of 24 or higher. Parkinson's participants are examined while ON their usual medication and should not have dyskinesias or need walking aids.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.