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

Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients

This study will test whether walking training on a C-Mill treadmill, with or without semi-immersive virtual reality, changes gut bacteria and metabolic markers in people aged 40–70 with moderate to advanced Parkinson's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo (other)
• Locations: 1 site (Messina, Messina)
• Trial ID: NCT07434089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 40–70 with Parkinson's disease, Hoehn and Yahr stage 2–4, who can walk independently (FAC > 2) and meet device weight/height limits and gastrointestinal eligibility criteria.

Not a fit: Patients with major gastrointestinal disease, recent GI surgery or acute GI inflammation, those taking drugs that alter GI motility, those outside device weight/height limits, or those unable to walk independently are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the work could identify rehabilitation approaches that favorably alter gut microbiota or metabolism and potentially improve clinical outcomes or guide personalized physiotherapy for Parkinson's patients.

How similar studies have performed: Previous work shows exercise and some VR approaches can improve motor function and that exercise can influence the gut microbiome, but using C-Mill gait training combined with semi-immersive VR specifically to target the gut-brain axis in Parkinson's is largely novel.

Eligibility criteria

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 this trial is running

Messina, Messina

• Irccs Centro Neurolesi Bonino Pulejo — Messina, Messina, Italy (RECRUITING)

Conditions: Parkinson Disease