Improve gait with C Mill
- Trial ID
- NCT07434089
- Official Title
- Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients
- Goal
- Improve gait with C Mill
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- C-Mill technology treadmill equipped with semi-immersive VR, C-Mill treatment without semi-immersive virtual reality (VR), Conventional physiotherapy training
Summary For Families
Researchers are testing whether targeted gait rehabilitation using the C-Mill can shift the intestinal microbiota via the gut-brain axis, which might relate to motor and non-motor Parkinson's symptoms. The C-Mill is an instrumented treadmill that delivers precise walking tasks, real-time feedback and semi-immersive virtual reality scenes to challenge and retrain gait and balance, the trial compares C-Mill with VR, C-Mill without VR, and conventional physiotherapy to see if that sensorimotor stimulation changes gut signals and bacterial communities. The study is enrolling about 60 people aged 40 to 70 with moderate to advanced PD, Hoehn and Yahr stages 2 to 4, who can walk independently. People with major gastrointestinal disease, recent antibiotics/probiotics or drugs that affect GI motility, recent GI surgery, or extreme height/weight are excluded.
Locations
- Irccs Centro Neurolesi Bonino Pulejo, Messina, Messina, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying C-Mill technology treadmill equipped with semi-immersive VR. Researchers are testing whether targeted gait rehabilitation using the C-Mill can shift the intestinal microbiota via the gut-brain axis, which might relate to motor and non-motor Parkinson's symptoms. The C-Mill is an instrumented treadmill that delivers precise walking tasks, real-time feedback and semi-immersive virtual reality scenes to challenge and retrain gait and balance, the trial compares C-Mill with VR, C-Mill without VR, and conventional physiotherapy to see if that sensorimotor stimulation changes gut signals and bacterial communities. The study is enrolling about 60 people aged 40 to 70 with moderate to advanced PD, Hoehn and Yahr stages 2 to 4, who can walk independently. People with major gastrointestinal disease, recent antibiotics/probiotics or drugs that affect GI motility, recent GI surgery, or extreme height/weight are excluded.
- Who can participate?
- Participants must be between 40 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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.