Improve balance using telerehabilitation games
- Trial ID
- NCT05773885
- Official Title
- Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease
- Goal
- Improve balance using telerehabilitation games
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- IRCCS San Raffaele Roma
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease
- Interventions
- VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy), Conventional rehabilitation
Summary For Families
The goal is to keep people with mid-stage Parkinson's connected to regular rehab at home so they can maintain mobility, balance, and daily function between clinic visits. The approach uses a VRRS tablet with serious games, which deliver guided, gamified physical exercises that adjust difficulty, give immediate feedback, track performance, and let therapists supervise remotely; it is being compared to conventional in-person rehabilitation. They are enrolling people 30 to 80 years old with Parkinson's by MDS criteria, Hoehn and Yahr stage 2 to 3 ON, minimal dyskinesias (MDS-UPDRS items 4.1 and 4.2 ≤ 2), MoCA ≥ 18, stable medications, home internet access, and a caregiver available for sessions.
Locations
- San Raffaele Cassino, Cassino, Frosinone, Italy
- IRCCS San Raffaele Roma, Rome, Italy, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy). The goal is to keep people with mid-stage Parkinson's connected to regular rehab at home so they can maintain mobility, balance, and daily function between clinic visits. The approach uses a VRRS tablet with serious games, which deliver guided, gamified physical exercises that adjust difficulty, give immediate feedback, track performance, and let therapists supervise remotely; it is being compared to conventional in-person rehabilitation. They are enrolling people 30 to 80 years old with Parkinson's by MDS criteria, Hoehn and Yahr stage 2 to 3 ON, minimal dyskinesias (MDS-UPDRS items 4.1 and 4.2 ≤ 2), MoCA ≥ 18, stable medications, home internet access, and a caregiver available for sessions.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 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 2 years and 7 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.