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

RecruitingNAAges 40 Years - 70 YearsAllIRCCS Centro Neurolesi Bonino Pulejo
NCT07434089 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • C-Mill technology treadmill equipped with semi-immersive VR
  • C-Mill treatment without semi-immersive virtual reality (VR)
  • Conventional physiotherapy training
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Where

1 site
Irccs Centro Neurolesi Bonino Pulejo
Messina, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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