|

Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease

RECRUITINGN/ASponsored by IRCCS Centro Neurolesi Bonino Pulejo
Actively Recruiting
PhaseN/A
SponsorIRCCS Centro Neurolesi Bonino Pulejo
Started2025-10-20
Est. completion2027-10-20
Eligibility
Age40 Years – 70 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 40 Years – 70 YearsHealthy volunteers accepted
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.

Conditions2

Parkinson DiseaseParkinson's Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.