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NCT Number: NCT07434089

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irccs Centro Neurolesi Bonino Pulejo

Messina, 98123, Italy

Location status: Recruiting

Location contact

Maria Lui

CONTACT

[email protected]

(+39) 09060128163

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-Mill technology treadmill equipped with semi-immersive VR

Device

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)

Device

C-Mill treatment will be administrated as a standalone therapy, without the integration of virtual reality (VR).

Conventional physiotherapy training

Other

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.

Primary outcomes

  1. Relative abundance of bacterial and fungal taxa in fecal samples

    Time frame: 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(%).

  2. Alpha Diversity of the Gut Microbiota

    Time frame: 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.

  3. Beta Diversity of the Gut Microbiota

    Time frame: 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.

  4. Distance Covered During the 6-Minute Walk Test

    Time frame: 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.

  5. Time Required to Complete the 10-Meter Walk Test

    Time frame: 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.

  6. Time Required to Complete the Timed Up and Go Test

    Time frame: 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.

  7. Balance Performance Assessed by the Berg Balance Scale

    Time frame: 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.

  8. Balance and Gait Performance Assessed by the Tinetti Scale

    Time frame: 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.

  9. Fear of Falling Assessed by the Short Falls Efficacy Scale-International

    Time frame: 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.

  10. Motor Symptom Severity Assessed by the MDS-UPDRS Part III (Motor Examination)

    Time frame: 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.

  11. Functional Independence Assessed by the Functional Independence Measure

    Time frame: 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.

  12. Severity of Constipation Assessed by the Constipation Scoring System

    Time frame: 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.

Secondary outcomes

  1. Serum Concentration of TNF-α

    Time frame: From enrollment to the 3 months follow-up

    Serum TNF-α, a key pro-inflammatory cytokine, measured by ELISA to assess systemic inflammatory activation. Unit of Measure: pg/mL

  2. Serum Concentration of IL-1β

    Time frame: From enrollment to the 3 months follow-up

    Serum IL-1β, a pro-inflammatory cytokine involved in immune response, measured by ELISA. Unit of Measure: pg/mL

  3. Serum Concentration of IL-6

    Time frame: From enrollment to the 3 months follow-up

    Serum IL-6, a pro-inflammatory cytokine that mediates systemic inflammation, measured by ELISA. Unit of Measure: pg/mL

  4. Serum Concentration of IL-10

    Time frame: From enrollment to the 3 months follow-up

    Serum IL-10, an anti-inflammatory cytokine that regulates immune responses, measured by ELISA. Unit of Measure: pg/mL

  5. Serum Concentration of IL-4

    Time frame: From enrollment to the 3 months follow-up

    Serum IL-4, an anti-inflammatory cytokine involved in immune modulation, measured by ELISA. Unit of Measure: pg/mL

  6. Serum Concentration of FNDC5

    Time frame: From enrollment to the 3 months follow-up

    Serum FNDC5, a metabolic peptide measured by ELISA. Unit of Measure: ng/mL

  7. Serum Concentration of Adiponectin

    Time frame: From enrollment to the 3 months follow-up

    Serum Adiponectin, a metabolic peptide measured by ELISA. Unit of Measure: ng/mL

  8. Serum Concentration of Reduced Glutathione

    Time frame: From enrollment to the 3 months follow-up

    Serum Reduced Glutathione (GSH), a key antioxidant reflecting oxidative stress status, measured by ELISA. Unit of Measure: µmol/L

  9. Serum Concentration of Oxidized Glutathione

    Time frame: From enrollment to the 3 months follow-up

    Serum Oxidized Glutathione (GSSG), the oxidized form of glutathione indicating oxidative stress, measured by ELISA. Unit of Measure: µmol/L

  10. Serum Concentration of High-Sensitivity C-Reactive Protein

    Time frame: From enrollment to the 3 months follow-up

    Serum High-Sensitivity C-Reactive Protein (hs-CRP), an acute-phase protein reflecting systemic inflammation, measured by ELISA. Unit of Measure: mg/L

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Collaborators

  • Università degli studi di Messina

Registry information

Official study title

Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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