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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
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.
C-Mill treatment will be administrated as a standalone therapy, without the integration of virtual reality (VR).
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.
Irccs Centro Neurolesi Bonino Pulejo
Messina, Messina, Italy
RECRUITINGRelative 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-up
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-up
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-up
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-up
Time Required to Complete the 10-Meter Walk Test
Walking ability assessed by measuring the time required to walk 10 meters at usual pace. Unit of Measure: seconds. Lower values indicate better walking performance.
Time frame: From enrollment to the 3 months follow-up
Time Required to Complete the Timed Up and Go Test
Mobility and fall risk assessed by the time needed to stand up, walk 3 meters, turn, return, and sit down. Unit of Measure: seconds. Lower values indicate better functional mobility.
Time frame: From enrollment to the 3 months follow-up
Balance Performance Assessed by the Berg Balance Scale
Balance measured using the Berg Balance Scale (range: 0-56). Higher scores indicate better balance and lower fall risk. Unit of Measure: total score.
Time frame: From enrollment to the 3 months follow-up
Balance and Gait Performance Assessed by the Tinetti Scale
Balance and gait evaluated using the Tinetti Scale (range: 0-29). Higher scores indicate better mobility and lower fall risk. Unit of Measure: total score.
Time frame: From enrollment to the 3 months follow-up
Fear of Falling Assessed by the Short Falls Efficacy Scale-International
Concern about falling measured using the Short Falls Efficacy Scale-International (range: 7-28). Higher scores indicate greater fear of falling. Unit of Measure: total score.
Time frame: From enrollment to the 3 months follow-up
Motor Symptom Severity Assessed by the MDS-UPDRS Part III (Motor Examination)
Motor impairment evaluated using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, the Motor Examination section. Total score range from 0 to 132. Unit of Measure: total score. Higher scores indicate worse motor impairment.
Time frame: From enrollment to the 3 months follow-up
Functional Independence Assessed by the Functional Independence Measure
Global functional status assessed using the Functional Independence Measure (range: 18-126). Higher scores indicate greater independence in daily activities. Unit of Measure: total score.
Time frame: From enrollment to the 3 months follow-up
Severity of Constipation Assessed by the Constipation Scoring System
Constipation severity measured using the Constipation Scoring System questionnaire (range: 0-30). Higher scores indicate more severe constipation. Unit of Measure: total score.
Time frame: From enrollment to the 3 months follow-up
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-up
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-up
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-up
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-up
Serum Concentration of IL-4
Serum IL-4, an anti-inflammatory cytokine involved in immune modulation, measured by ELISA. Unit of Measure: pg/mL
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of FNDC5
Serum FNDC5, a metabolic peptide measured by ELISA. Unit of Measure: ng/mL
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Adiponectin
Serum Adiponectin, a metabolic peptide measured by ELISA. Unit of Measure: ng/mL
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Reduced Glutathione
Serum Reduced Glutathione (GSH), a key antioxidant reflecting oxidative stress status, measured by ELISA. Unit of Measure: µmol/L
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Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Oxidized Glutathione
Serum Oxidized Glutathione (GSSG), the oxidized form of glutathione indicating oxidative stress, measured by ELISA. Unit of Measure: µmol/L
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of High-Sensitivity C-Reactive Protein
Serum High-Sensitivity C-Reactive Protein (hs-CRP), an acute-phase protein reflecting systemic inflammation, measured by ELISA. Unit of Measure: mg/L
Time frame: From enrollment to the 3 months follow-up