VRRS Tablet for Parkinson's (NCT05773885)
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?
- 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 2 years and 7 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Experimental Group participants will carry out 30 sessions over 6-10 weeks, at 3-5 days per week.