Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorIRCCS Centro Neurolesi Bonino Pulejo
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
C-Mill technology treadmill equipped with semi-immersive VR
DeviceC-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.
C-Mill treatment without semi-immersive virtual reality (VR)
DeviceC-Mill treatment will be administrated as a standalone therapy, without the integration of virtual reality (VR).
Conventional physiotherapy training
Other interventionWill 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: C-mill + VR treatedExperimental treatment 1 intervention
Group B: C-Mill treatedExperimental treatment 1 intervention
Group C: Conventional physiotherapy treatedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Relative abundance of bacterial and fungal taxa in fecal samples
Relative abundance of bacterial and fungal taxa determined by sequencing the V3-V4 regions of the 16S rRNA and ITS1-IT2 regions from fecal samples. Unit of measurement: percentage of total sequencing reads(%).
Time frame
From enrollment to the 3 months follow-up2
Alpha Diversity of the Gut Microbiota
Within-sample microbial diversity derived from sequencing of the V3-V4 regions of the 16S rRNA gene and ITS1-ITS2 regions from fecal samples, expressed as an alpha diversity index. Unit of Measure: alpha diversity index value. Higher values indicate greater microbial diversity.
Time frame
From enrollment to the 3 months follow-up3
Beta Diversity of the Gut Microbiota
Between-sample microbial community derived from the sequencing of V3-V4 regions of the 16S rRNA and ITS1-ITS2 and expressed as a beta diversity distance. Unit of Measure: beta diversity distance. Higher values indicate greater dissimilarity between samples.
Time frame
From enrollment to the 3 months follow-up4
Distance Covered During the 6-Minute Walk Test
Functional walking capacity measured as the total distance walked during the 6-Minute Walk Test. Unit of Measure: meters. Higher values indicate better walking capacity.
Time frame
From enrollment to the 3 months follow-upSecondary outcomes
1
Serum Concentration of TNF-α
Serum TNF-α, a key pro-inflammatory cytokine, measured by ELISA to assess systemic inflammatory activation. Unit of Measure: pg/mL
Time frame
From enrollment to the 3 months follow-up2
Serum Concentration of IL-1β
Serum IL-1β, a pro-inflammatory cytokine involved in immune response, measured by ELISA. Unit of Measure: pg/mL
Time frame
From enrollment to the 3 months follow-up3
Serum Concentration of IL-6
Serum IL-6, a pro-inflammatory cytokine that mediates systemic inflammation, measured by ELISA. Unit of Measure: pg/mL
Time frame
From enrollment to the 3 months follow-up4
Serum Concentration of IL-10
Serum IL-10, an anti-inflammatory cytokine that regulates immune responses, measured by ELISA. Unit of Measure: pg/mL
Time frame
From enrollment to the 3 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Centro Neurolesi Bonino Pulejo
Lead sponsor
Università degli studi di Messina
Collaborator
Source ClinicalTrials.gov