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

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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;
• 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;
• anamnesis suggestive of GI cancer pathology.