Actively Recruiting
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2022-08-09
260
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying neurological diseases including Multiple Sclerosis, Parkinson Disease, Stroke, and acquired brain injury to understand which patients respond best to robotic-assisted gait training using the G-EO system. This study aims to develop a statistical model predicting treatment effectiveness based on patient and treatment characteristics. The goal is to identify variables that can forecast the success of this rehabilitation method. Participants will receive robotic-assisted gait training with the G-EO system, a device that guides foot movement to assist balance and walking. The treatment plan includes a minimum of 10 sessions at least twice per week. Clinical and instrumental parameters, such as session number, frequency, step length, cadence, and body weight support, will be recorded along with patient data like age, disease duration, and comorbidities to build the predictive model. Participants will be evaluated before treatment (baseline) and monitored through the treatment period and follow-up. Assessments include gait speed changes, trunk control, mobility, strength, walking endurance, balance confidence, cognitive function, and other measures. The primary outcome is the change in gait speed from baseline to the end of treatment and after two months. Data collection includes clinical scores and instrument-based gait indexes to understand treatment impact and safety throughout the study.
CONDITIONS
Brief Title
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Multiple Sclerosis, Parkinson Disease, Stroke or acquired brain injury
- Minimum of 10 sessions with the G-EO system
- At least 2 sessions per week
- Age 18 years or older
- Ability to walk at least 10 meters, with or without aid
- Indicated for robotic treatment in the therapeutic plan
- Body size suitable for the robotic device
- Ability to maintain vertical position for 7 minutes
- Ability to sit without support for 30 seconds
You will not qualify if you...
- Severe limitations of joint range of motion
- Medical problems that impair walking (e.g., fractures, severe pain, severe osteoporosis, severe spasticity)
- Skin lesions in contact areas with the device
- Seizures that may be triggered by the G-EO system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 weeks with a minimum of 10 sessions, at least 2 sessions per week
Participants receive robotic-assisted gait training using the G-EO system according to their therapeutic plan.
Multiple sessions depending on individual treatment plans
Duration - 2 months following the end of treatment
Participants are monitored to assess changes in gait speed and other clinical outcomes after treatment.
Follow-up visits as scheduled for outcome assessments
Trial Site Locations
Total: 1 location
1
Don Gnocchi Foundation
Milan, Italy, 20148
Actively Recruiting
Research Team
D
Davide Cattaneo, PhD
T
Thomass Bowman, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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