Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
Recruiting · NCT07434089 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Irccs Centro Neurolesi Bonino Pulejo - Messina, Messina, Italy