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Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07434089•IRCCS Centro Neurolesi Bonino Pulejo

View on ClinicalTrials.gov

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

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Messina, Italy

Key Dates

Start Date

October 20, 2025

Primary Completion Date

October 20, 2027

Completion Date

October 20, 2028

Last Updated

February 25, 2026

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

C-Mill technology treadmill equipped with semi-immersive VR

DEVICE

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

DEVICE

Conventional physiotherapy training

OTHER

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations