Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorIRCCS Centro Neurolesi Bonino Pulejo
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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;
Trial design
Treatments tested in this trial
- C-Mill technology treadmill equipped with semi-immersive VR
- C-Mill treatment without semi-immersive virtual reality (VR)
- Conventional physiotherapy training
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
IRCCS Centro Neurolesi Bonino Pulejo
Lead sponsor
Università degli studi di Messina
Collaborator
Source ClinicalTrials.gov