Gut-Brain Axis and Rehabilitation: Study on the Effects of C-Mill Technology on the Intestinal Microbiota of Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relative abundance of bacterial and fungal taxa in fecal samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
C-mill + VR treated
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.
干预措施: C-Mill technology treadmill equipped with semi-immersive VR (Device)
C-Mill treated
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.
干预措施: C-Mill treatment without semi-immersive virtual reality (VR) (Device)
Conventional physiotherapy treated
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.
干预措施: Conventional physiotherapy training (Other)
结局指标
主要结局
Relative abundance of bacterial and fungal taxa in fecal samples
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Serum Concentration of TNF-α(From enrollment to the 3 months follow-up)
- Serum Concentration of IL-1β(From enrollment to the 3 months follow-up)
- Serum Concentration of IL-6(From enrollment to the 3 months follow-up)
- Serum Concentration of IL-10(From enrollment to the 3 months follow-up)
- Serum Concentration of IL-4(From enrollment to the 3 months follow-up)
- Serum Concentration of FNDC5(From enrollment to the 3 months follow-up)
- Serum Concentration of Adiponectin(From enrollment to the 3 months follow-up)
- Serum Concentration of Reduced Glutathione(From enrollment to the 3 months follow-up)
- Serum Concentration of Oxidized Glutathione(From enrollment to the 3 months follow-up)
- Serum Concentration of High-Sensitivity C-Reactive Protein(From enrollment to the 3 months follow-up)
研究者
Maria Lui
Principal Investigator
IRCCS Centro Neurolesi Bonino Pulejo