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| Name | Class |
|---|---|
| Università degli studi di Messina | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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(%). | 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. | 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. | 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. | 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. | From enrollment to the 3 months follow-up |
| Time Required to Complete the Timed Up and Go Test |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the 3 months follow-up |
| Serum Concentration of IL-1β |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Centro Neurolesi Bonino Pulejo | Recruiting | Messina | Messina | 98123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37759913 | Background | 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. | |
| 36280946 | Background |
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| 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). |
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| 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. |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From enrollment to the 3 months follow-up |
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| 34368491 | Background | Trindade 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. |
| 31607351 | Background | Mak 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. |
| 39149144 | Background | Tang 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. |
| 31275225 | Background | Frazzitta 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. |
| 30245949 | Background | Fayyaz 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. |
| 29330419 | Background | Yu 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. |
| 35336852 | Background | Cataldi 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. |
| 39019779 | Background | Gao 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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