Parkinson DiseaseNCT07434089
Impact of C-Mill Rehabilitation on the Gut-Brain Axis in Parkinson's Disease
A study testing C-Mill technology treadmill equipped with semi-immersive VR, C-Mill treatment without semi-immersive virtual reality (VR) and Conventional physiotherapy training in people with Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- C-Mill technology treadmill equipped with semi-immersive VR, C-Mill treatment without semi-immersive virtual reality (VR) and Conventional physiotherapy training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2025to 20 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Centro Neurolesi Bonino Pulejo
Messina, Messina, 98123
Maria Lui, (+39) 09060128163, maria.lui@irccsme.it
About this study
Official title: Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients
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.
- Conditions
- Parkinson Disease
- Being tested
- C-Mill technology treadmill equipped with semi-immersive VR, C-Mill treatment without semi-immersive virtual reality (VR), Conventional physiotherapy training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Mill technology treadmill equipped with semi-immersive VRDevice
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 trainingOther
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 group | Role | What they receive |
|---|---|---|
| C-mill + VR treated | Experimental | includes 20 patients with PD undergoing C-Mill treatment combined with semi-immersive virtual reality (VR). This group will participate in 12 training sessions, each lasting 45 minutes, four times a week for three weeks. Gait training in each session will include exercises such as path with obstacles, tandem walking, slalom, and walking at varying speeds, all enhanced with semi-immersive VR scenarios projected on the treadmill's floor. 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. Receives: Device: C-Mill technology treadmill equipped with semi-immersive VR |
| C-Mill treated | Experimental | Consists of 20 patients with Parkinson's Disease (PD) undergoing C-Mill treatment as a standalone therapy, without the integration of virtual reality (VR). Participants will complete 12 training sessions, each lasting 45 minutes, four times a week for three weeks. The training sessions will include exercises such as tandem walking, slalom walking, obstacle courses, and walking at varying speeds, all designed to enhance gait and balance. Receives: Device: C-Mill treatment without semi-immersive virtual reality (VR) |
| Conventional physiotherapy treated | Experimental | Consists of 20 patients with PD, who will undergo conventional physiotherapy training 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. Gait training will incorporate obstacle courses (e.g., bricks, boxes) of varying shapes and colors, or paths created by the physiotherapist using furniture and equipment (e.g., chairs, traffic cones, sandbags). Patients will also perform slalom walking exercises, with auditory stimuli (e.g., music, therapist's voice) and visual cues (e.g., colored tape on the floor) to guide the exercises, adjusting their walking speed based on the auditory cues provided by the therapist. Receives: Other: Conventional physiotherapy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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(%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the 3 months follow-up
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Oct 2025
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli studi di Messina
- Responsible party
- Principal investigator, Maria Lui, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434089
- Sponsor's protocol ID
- GM-REHAB-2025
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pullia M, Ciatto L, Andronaco G, Donato C, Aliotta RE, Quartarone A, De Cola MC, Bonanno M, Calabro RS, Cellini R. Treadmill Training Plus Semi-Immersive Virtual Reality in Parkinson's Disease: Results from a Pilot Study. Brain Sci. 2023 Sep 12;13(9):1312. doi: 10.3390/brainsci13091312.
PubMed 37759913Malik AN, Tariq H, Afridi A, Rathore FA. Technological advancements in stroke rehabilitation. J Pak Med Assoc. 2022 Aug;72(8):1672-1674. doi: 10.47391/JPMA.22-90.
PubMed 36280946Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.
PubMed 28000926Mayer EA, Tillisch K. The brain-gut axis in abdominal pain syndromes. Annu Rev Med. 2011;62:381-96. doi: 10.1146/annurev-med-012309-103958.
PubMed 21090962Drossman DA, Tack J, Ford AC, Szigethy E, Tornblom H, Van Oudenhove L. Neuromodulators for Functional Gastrointestinal Disorders (Disorders of Gut-Brain Interaction): A Rome Foundation Working Team Report. Gastroenterology. 2018 Mar;154(4):1140-1171.e1. doi: 10.1053/j.gastro.2017.11.279. Epub 2017 Dec 22.
PubMed 29274869Trindade MFD, Viana RA. Effects of auditory or visual stimuli on gait in Parkinsonic patients: a systematic review. Porto Biomed J. 2021 Aug 4;6(4):e140. doi: 10.1097/j.pbj.0000000000000140. eCollection 2021 Jul-Aug.
PubMed 34368491Mak MKY, Wong-Yu ISK. Exercise for Parkinson's disease. Int Rev Neurobiol. 2019;147:1-44. doi: 10.1016/bs.irn.2019.06.001. Epub 2019 Jun 27.
PubMed 31607351Tang X, Huang Z, Zhu G, Liang H, Sun H, Zhang Y, Tan Y, Cui M, Gong H, Wang X, Chen YH. Matching supplementary motor area-primary motor cortex paired transcranial magnetic stimulation improves motor dysfunction in Parkinson's disease: a single-center, double-blind randomized controlled clinical trial protocol. Front Aging Neurosci. 2024 Aug 1;16:1422535. doi: 10.3389/fnagi.2024.1422535. eCollection 2024.
PubMed 39149144Frazzitta G, Ferrazzoli D, Folini A, Palamara G, Maestri R. Severe Constipation in Parkinson's Disease and in Parkinsonisms: Prevalence and Affecting Factors. Front Neurol. 2019 Jun 18;10:621. doi: 10.3389/fneur.2019.00621. eCollection 2019.
PubMed 31275225Fayyaz M, Jaffery SS, Anwer F, Zil-E-Ali A, Anjum I. The Effect of Physical Activity in Parkinson's Disease: A Mini-Review. Cureus. 2018 Jul 18;10(7):e2995. doi: 10.7759/cureus.2995.
PubMed 30245949Yu QJ, Yu SY, Zuo LJ, Lian TH, Hu Y, Wang RD, Piao YS, Guo P, Liu L, Jin Z, Li LX, Chan P, Chen SD, Wang XM, Zhang W. Parkinson disease with constipation: clinical features and relevant factors. Sci Rep. 2018 Jan 12;8(1):567. doi: 10.1038/s41598-017-16790-8.
PubMed 29330419Cataldi S, Bonavolonta V, Poli L, Clemente FM, De Candia M, Carvutto R, Silva AF, Badicu G, Greco G, Fischetti F. The Relationship between Physical Activity, Physical Exercise, and Human Gut Microbiota in Healthy and Unhealthy Subjects: A Systematic Review. Biology (Basel). 2022 Mar 21;11(3):479. doi: 10.3390/biology11030479.
PubMed 35336852Gao X, Zhang P. Exercise perspective: Benefits and mechanisms of gut microbiota on the body. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2024 Apr 28;49(4):508-515. doi: 10.11817/j.issn.1672-7347.2024.230550. Chinese, English.
PubMed 39019779Mach N, Fuster-Botella D. Endurance exercise and gut microbiota: A review. J Sport Health Sci. 2017 Jun;6(2):179-197. doi: 10.1016/j.jshs.2016.05.001. Epub 2016 May 10.
PubMed 30356594Sohail MU, Yassine HM, Sohail A, Thani AAA. Impact of Physical Exercise on Gut Microbiome, Inflammation, and the Pathobiology of Metabolic Disorders. Rev Diabet Stud. 2019;15:35-48. doi: 10.1900/RDS.2019.15.35. Epub 2019 Aug 4.
PubMed 31380886
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT07434089
- Acronym / sponsor ID
- GM-REHAB-2025
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Collaborators
- Università degli studi di Messina
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-mill + VR treated | Experimental | Device: C-Mill technology treadmill equipped with semi-immersive VRincludes 20 patients with PD undergoing C-Mill treatment combined with semi-immersive virtual reality (VR). This group will participate in 12 training sessions, each lasting 45 minutes, four times a week for three weeks. Gait training in each session will include exercises such as path with obstacles, tandem walking, slalom, and walking at varying speeds, all enhanced with semi-immersive VR scenarios projected on the treadmill's floor. 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 treated | Experimental | Device: C-Mill treatment without semi-immersive virtual reality (VR)Consists of 20 patients with Parkinson's Disease (PD) undergoing C-Mill treatment as a standalone therapy, without the integration of virtual reality (VR). Participants will complete 12 training sessions, each lasting 45 minutes, four times a week for three weeks. The training sessions will include exercises such as tandem walking, slalom walking, obstacle courses, and walking at varying speeds, all designed to enhance gait and balance. |
| Conventional physiotherapy treated | Experimental | Other: Conventional physiotherapy trainingConsists of 20 patients with PD, who will undergo conventional physiotherapy training 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. Gait training will incorporate obstacle courses (e.g., bricks, boxes) of varying shapes and colors, or paths created by the physiotherapist using furniture and equipment (e.g., chairs, traffic cones, sandbags). Patients will also perform slalom walking exercises, with auditory stimuli (e.g., music, therapist's voice) and visual cues (e.g., colored tape on the floor) to guide the exercises, adjusting their walking speed based on the auditory cues provided by the therapist. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Mill technology treadmill equipped with semi-immersive VRC-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. | Device | C-mill + VR treated |
| 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). | Device | C-Mill treated |
| Conventional physiotherapy trainingWill 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. | Other | Conventional physiotherapy treated |
Primary outcome
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(%).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Serum Concentration of TNF-α
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of IL-1β
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of IL-6
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of IL-10
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of IL-4
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of FNDC5
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Adiponectin
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Reduced Glutathione
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of Oxidized Glutathione
Time frame: From enrollment to the 3 months follow-up
Serum Concentration of High-Sensitivity C-Reactive Protein
Time frame: From enrollment to the 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 37759913Pullia M, Ciatto L, Andronaco G, Donato C, Aliotta RE, Quartarone A, De Cola MC, Bonanno M, Calabro RS, Cellini R. Treadmill Training Plus Semi-Immersive Virtual Reality in Parkinson's Disease: Results from a Pilot Study. Brain Sci. 2023 Sep 12;13(9):1312. doi: 10.3390/brainsci13091312.
- Background: PubMed 36280946Malik AN, Tariq H, Afridi A, Rathore FA. Technological advancements in stroke rehabilitation. J Pak Med Assoc. 2022 Aug;72(8):1672-1674. doi: 10.47391/JPMA.22-90.
- Background: PubMed 28000926Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.
- Background: PubMed 21090962Mayer EA, Tillisch K. The brain-gut axis in abdominal pain syndromes. Annu Rev Med. 2011;62:381-96. doi: 10.1146/annurev-med-012309-103958.
- Background: PubMed 29274869Drossman DA, Tack J, Ford AC, Szigethy E, Tornblom H, Van Oudenhove L. Neuromodulators for Functional Gastrointestinal Disorders (Disorders of Gut-Brain Interaction): A Rome Foundation Working Team Report. Gastroenterology. 2018 Mar;154(4):1140-1171.e1. doi: 10.1053/j.gastro.2017.11.279. Epub 2017 Dec 22.
- Background: PubMed 34368491Trindade MFD, Viana RA. Effects of auditory or visual stimuli on gait in Parkinsonic patients: a systematic review. Porto Biomed J. 2021 Aug 4;6(4):e140. doi: 10.1097/j.pbj.0000000000000140. eCollection 2021 Jul-Aug.
- Background: PubMed 31607351Mak MKY, Wong-Yu ISK. Exercise for Parkinson's disease. Int Rev Neurobiol. 2019;147:1-44. doi: 10.1016/bs.irn.2019.06.001. Epub 2019 Jun 27.
- Background: PubMed 39149144Tang X, Huang Z, Zhu G, Liang H, Sun H, Zhang Y, Tan Y, Cui M, Gong H, Wang X, Chen YH. Matching supplementary motor area-primary motor cortex paired transcranial magnetic stimulation improves motor dysfunction in Parkinson's disease: a single-center, double-blind randomized controlled clinical trial protocol. Front Aging Neurosci. 2024 Aug 1;16:1422535. doi: 10.3389/fnagi.2024.1422535. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Mill technology treadmill equipped with semi-immersive VR, C-Mill treatment without semi-immersive virtual reality (VR) and Conventional physiotherapy training in people with Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of bacterial and fungal taxa in fecal samples (time frame: From enrollment to the 3 months follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434089, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.