NCT07434089Recruiting
Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
The GM-REHAB-2025 study aims to evaluate the impact of physiotherapy interventions using the C-Mill treadmill, with and without semi-immersive virtual reality, on gut microbiota and metabolic parameters in patients with Parkinson's disease. Three groups will be involved: one undergoing conventional physiotherapy, one treated with the C-Mill without virtual reality (VR), and one treated with C-Mill technology combined with VR. Clinical assessments and the collection of biological samples (stool, serum, and plasma) will be carried out at three time points: at baseline, at the end of treatment (21 days), and after 3 months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Feb 2026
- Start date
- Oct 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Diseases
- Parkinson disease
- NCT number
- NCT07434089
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Oct 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute GI phlogosis or GI disease in the last 4 weeks before recruitment;
- Use of domperidone, or any drug potentially affecting gastrointestinal motility and integrity;
- Use, in the last 4 weeks preceding the recruitment and until t2, of pre-probiotics or therapy based upon steroids, nonsteroidal anti-inflammatory drugs, antibiotics or antifungals;
Other illness
- chronic gastro-intestinal (GI) disease including malabsorption;
- clinical history of gastric lesions, gastro-resection or major intestinal surgery;
- systemic and/or neurologic infectious, inflammatory, or autoimmune diseases of gastro-intestinal (GI) eg. Chron disease;
- anamnesis suggestive of GI cancer pathology.
Other
- PD patients with (1) weight \> 135 kg and Height \> 200 cm
- Open lesions or bandages whether in contact with the harness of C-Mill strumentation
Who the study is looking for
- Diagnosis of PD according to the Movement Disorder Society Clinical
- Diagnostic Criteria for Parkinson's Disease
- Age comprised between 40 to 70 years
- Patients with moderate to advanced disease (2 ≤ Hoehn and Yahr classification grade ≤ 4)
- Individuals able to walk independently (FAC \> 2)
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.