RecruitingNot ApplicableNCT07434089

Impact of C-Mill Rehabilitation on the Gut-Brain Axis 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

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Enrollment

60 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria9

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.

Interventions

DEVICEC-Mill technology treadmill equipped with semi-immersive VR

C-Mill treatment combined with semi-immersive virtual reality (VR). The VR component will feature visual obstacles, such as virtual traffic cones or country paths, in conjunction with audio-visual stimuli to promote engagement and guide movement.

DEVICEC-Mill treatment without semi-immersive virtual reality (VR)

C-Mill treatment will be administrated as a standalone therapy, without the integration of virtual reality (VR).

OTHERConventional physiotherapy training

Will be carried under the manual guidance and supervision of a physiotherapist. The rehabilitation program will include weight-shifting exercises, as well as monopodal and bipodal balance exercises.