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

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

Recruiting
40-70 years
All
Phase N/A

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Overview

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

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.

Study details
    Parkinson Disease

NCT07434089

IRCCS Centro Neurolesi Bonino Pulejo

26 February 2026

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