Improve arm dexterity with robotics
- Trial ID
- NCT06906679
- Official Title
- Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study
- Goal
- Improve arm dexterity with robotics
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- IRCCS San Raffaele Roma
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- Experimental Group, control group
Summary For Families
The goal is to help people with moderate Parkinson's improve upper limb movement, strength, coordination and everyday arm use. A robotic end-effector device attaches at the hand or wrist and guides repetitive, assisted reaching, grasping and fine-motor exercises, giving consistent movement patterns and sensory feedback to promote motor relearning and reduce stiffness; the multicenter trial randomly compares robot-assisted sessions to standard care. They are enrolling about 40 people aged 30 to 80 with Parkinson's by UK Brain Bank criteria, Hoehn and Yahr stage 2 to 3 while ON, a MoCA score of at least 17.54, stable medications for 4 or more weeks, and the ability to follow and consent to the exercise program.
Locations
- San Raffaele Cassino, Cassino, FR, Italy
- IRCCS San Raffaele Roma, Rome, Lazio, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Experimental Group. The goal is to help people with moderate Parkinson's improve upper limb movement, strength, coordination and everyday arm use. A robotic end-effector device attaches at the hand or wrist and guides repetitive, assisted reaching, grasping and fine-motor exercises, giving consistent movement patterns and sensory feedback to promote motor relearning and reduce stiffness; the multicenter trial randomly compares robot-assisted sessions to standard care. They are enrolling about 40 people aged 30 to 80 with Parkinson's by UK Brain Bank criteria, Hoehn and Yahr stage 2 to 3 while ON, a MoCA score of at least 17.54, stable medications for 4 or more weeks, and the ability to follow and consent to the exercise program.
- 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.
- 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.