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

Plain Language Summary

Simplified for easier understanding

This study examines whether a specialised treadmill rehabilitation programme (C-Mill treadmill with virtual reality) can improve walking and balance in people with Parkinson's disease, and whether it also affects gut health — which is increasingly linked to brain health. **You may be eligible if...** - You have a confirmed diagnosis of Parkinson's disease - You are between 40 and 70 years old - You have moderate to advanced Parkinson's (Hoehn and Yahr stage 2 to 4) - You are able to walk independently (even with some assistance) **You may NOT be eligible if...** - You weigh more than 135 kg or are taller than 200 cm - You have severe balance or walking problems that make treadmill use unsafe - You have dementia or other conditions that prevent participation - You have a recent history of falls causing injury Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.