Actively Recruiting
Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
Led by IRCCS Centro Neurolesi Bonino Pulejo · Updated on 2026-02-25
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
IRCCS Centro Neurolesi Bonino Pulejo
Lead Sponsor
U
Università degli studi di Messina
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria
- Age between 40 and 70 years
- Moderate to advanced Parkinson's disease (Hoehn and Yahr grade between 2 and 4)
- Ability to walk independently (Functional Ambulation Category score greater than 2)
You will not qualify if you...
- Weight over 135 kg or height over 200 cm
- Open wounds or bandages in contact with the C-Mill harness
- Chronic gastrointestinal diseases including malabsorption
- History of gastric lesions, gastro-resection, or major intestinal surgery
- Systemic or neurological infectious, inflammatory, or autoimmune gastrointestinal diseases such as Crohn's disease
- Acute gastrointestinal inflammation or disease within 4 weeks before recruitment
- Use of domperidone or any drug affecting gastrointestinal motility and integrity
- Use of pre-probiotics, steroids, nonsteroidal anti-inflammatory drugs, antibiotics, or antifungals within 4 weeks before recruitment and until the end of treatment
- History suggesting gastrointestinal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Irccs Centro Neurolesi Bonino Pulejo
Messina, Messina, Italy, 98123
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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