C-Mill treadmill rehab with and without virtual reality for the gut-brain connection in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

People with moderate-to-advanced Parkinson's disease will be assigned to one of three physiotherapy groups: conventional physiotherapy, C-Mill treadmill without virtual reality, or C-Mill treadmill combined with semi-immersive virtual reality. Interventions run over a 21-day program with clinical evaluations and biological sample collection at baseline, end of treatment (21 days), and at a 3-month follow-up. Stool, serum, and plasma samples will be collected to profile gut microbiota and metabolic parameters alongside clinical gait and function measures. The approach is designed to link different gait-rehabilitation modalities to changes in gut-brain axis markers.

Why it matters

Who can join: the full rules

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's running

• Irccs Centro Neurolesi Bonino Pulejo
  Messina, Messina, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.