Parkinson's Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Irccs Centro Neurolesi Bonino Pulejo
RECRUITING
Messina
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2028-10-20
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Università degli studi di Messina
Leads: IRCCS Centro Neurolesi Bonino Pulejo

This content was sourced from clinicaltrials.gov