RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

C-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.

DEVICE

C-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).

OTHER

Conventional 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.

Locations (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Messina, Italy