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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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).

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.

Study 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

Primary outcome measure(s)

• Relative abundance of bacterial and fungal taxa in fecal samples — From enrollment to the 3 months follow-up
  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(%).
• Alpha Diversity of the Gut Microbiota — From enrollment to the 3 months follow-up
  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.
• Beta Diversity of the Gut Microbiota — From enrollment to the 3 months follow-up
  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.
• Distance Covered During the 6-Minute Walk Test — From enrollment to the 3 months follow-up
  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 Required to Complete the 10-Meter Walk Test — From enrollment to the 3 months follow-up
  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 Required to Complete the Timed Up and Go Test — From enrollment to the 3 months follow-up
  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.
• Balance Performance Assessed by the Berg Balance Scale — From enrollment to the 3 months follow-up
  Balance measured using the Berg Balance Scale (range: 0-56). Higher scores indicate better balance and lower fall risk. Unit of Measure: total score.
• Balance and Gait Performance Assessed by the Tinetti Scale — From enrollment to the 3 months follow-up
  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.
• Fear of Falling Assessed by the Short Falls Efficacy Scale-International — From enrollment to the 3 months follow-up
  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.
• Motor Symptom Severity Assessed by the MDS-UPDRS Part III (Motor Examination) — From enrollment to the 3 months follow-up
  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.
• Functional Independence Assessed by the Functional Independence Measure — From enrollment to the 3 months follow-up
  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.
• Severity of Constipation Assessed by the Constipation Scoring System — From enrollment to the 3 months follow-up
  Constipation severity measured using the Constipation Scoring System questionnaire (range: 0-30). Higher scores indicate more severe constipation. Unit of Measure: total score.

Trial sites (1)

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