Predicting effectiveness of robotic treatment for neurological diseases
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
This study is testing how well robotic treatment can help people with neurological diseases like Multiple Sclerosis, Stroke, and Parkinson's by looking at different factors that might affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05493514 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a statistical model to predict the effectiveness of robotic treatment using the G-EO system in patients with neurological diseases such as Multiple Sclerosis, Stroke, and Parkinson Disease. The study will assess various clinical and instrumental characteristics of participants to identify predictors of treatment success. Participants will undergo robotic-assisted gait training, and their responses will be analyzed to understand which factors contribute to better outcomes. The findings could help tailor robotic therapies to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with Multiple Sclerosis, Parkinson Disease, Stroke, or acquired brain injury who can walk at least 10 meters.
Not a fit: Patients with severe limitations in joint range of motion or other medical conditions that compromise walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of robotic treatments for patients with neurological disorders by identifying who will benefit most.
How similar studies have performed: While robotic rehabilitation is a growing field, this specific approach to predicting treatment effectiveness using statistical modeling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Multiple Sclerosis, Parkinson Disease, Stroke or acquired brain injury * Minimum number of sessions: 10 sessions with the GEO system * Minimum frequency of sessions: 2 per week * Age ≥ 18 years * Ability to walk for at least 10 meters, also with aid * Indication of robotic treatment in the therapeutic plan * Body size suitable for the robotic device * ability to maintain verticality for 7 minutes; * ability to maintain the sitting position without support for 30 seconds; Exclusion Criteria: * severe limitations of articular range of motion; * medical problems compromising walking (e.g. fractures, pain, severe osteoporosis or severe spasticity); * Presence of skin lesions in the areas of contact with the device; * Presence of seizures that may be triggered by the use of the G-EO system.
Where this trial is running
Milan
- Don Gnocchi Foundation — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Davide Cattaneo, PhD
- Email: dcattaneo@dongnocchi.it
- Phone: 3383891807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.