C-Mill technology treadmill equipp… for Parkinson's (NCT07434089)
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?
- 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?
- There will be three assessment visits: at baseline, at the end of treatment (21 days), and after 3 months.