NCT07434089

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-10-20
• Completion: 2028-10-20
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Italy