Experimental Group for Parkinson's (NCT06906679)
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?
- 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.
- 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?
- Each participant will follow 20 sessions, 3 times per week, of their assigned upper limb rehabilitation treatment.