An observational study in Multiple Sclerosis, Stroke and Parkinson Disease, sponsored by Fondazione Don Carlo Gnocchi Onlus. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational
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Among 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus — 7 open to participants now, 8 under way, none of them phase 3. Multiple Sclerosis · Fondazione Don Carlo Gnocchi Onlus.
Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, this one is one of 3 that started in 2022, is one of 4 observational ones, and was the 18th registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →7 of the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus are open now, in 1 country. Recruiting first, the newest first:
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 25–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–60 · Healthy volunteers
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–70
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18+
By country, each count listing its studies:
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2022.
This study's planned enrollment of 260 is above the median of 100 across 971 observational studies indexed under Multiple Sclerosis.
Median enrollment 48 across the 21 interventional studies, 142 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
1 of the studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05493514Fondazione Don Carlo Gnocchi OnlusClinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System | 2027-04-01 |
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Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment
In recent years, robotic devices have been used to assist balance and gait rehabilitation of people with neurological disorders. In particular, the G-EO system (Reha Technology AG, Switzerland) is a robotic end-effector device guiding the movement of the feet. It is currently unclear which variables are the predictors of treatment success. Indeed, the effectiveness of the GEO treatment may depends on the characteristics of the treatment itself (instrumental parameters defined by the physiotherapist using the device) and on the characteristics of the subject receiving the treatment. Therefore, it is necessary to measure these clinical and instrumental characteristics to understand which are predictors of treatment effects. Parameters obtained from this assessment can be used to elaborate statistical models. In our study the statistical model will be defined as follows: The change in the primary outcome measure after the robotic treatment will be considered as dependent variable of the model. All the "secondary" clinical outcome measures will be measured only at T0 and will be considered in the model as independent variables, along with the participants characteristics (age, gender, disease, disease duration, falls number, numbers of comorbidity, type of hospitalization) and the treatment characteristics (sessions number, frequency, duration, step length, cadence, gait speed, body weight support, distance traveled). The results of the model will suggest which subjects are most responsive to this type of treatment and which variables can be considered as predictors of the treatment success.
People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke
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Exclusion Criteria:
People with neurological disease (Multiple Sclerosis, Parkinson Disease, Stroke and acquired brain injuries) will be recruited according to inclusion and exclusion criteria.
Device: Robotic Assisted Gait Training with G-EO system
Robotic-assisted gait training is a rehabilitation treatment that applies robotic technologies to improve mobility of patients with stroke or other neurological disorders. In this study, participants will use the G-EO system robotic device according to the daily clinical practice of the Don Gnocchi Foundation.
Change in gait speed
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. The time to cover 6 meters is measured and the walking speed is calculated. higher speed indicates better performance.
Time frame: baseline (T0), at the end of the treatment in accordance with the duration foreseen by the therapeutic plan of each subject up to a minimum of 2 weeks, (T1) and 2 months of follow up
Trunk control
The Trunk Control Test can be used to assess the motor impairment of the trunk in a patient, the total score range is 0 (minimum) to 100 (maximum, indicating better performance)
Time frame: baseline (T0)
Mobility
The Modified Rivermead Mobility Index (MRMI) is recommended to assess mobility in neurological patients. the total score range is 0 (minimum) to 40 (maximum, indicating better mobility)
Time frame: baseline (T0)
Strength
The 5 time sit to stand test asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults and patient population. The time to stand up and sit down 5 times is measured. Lower time indicates better performance.
Time frame: baseline (T0)
Walking Endurance
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. the distance covered in 6 minutes is measured. Greater distance indicates better performance.
Time frame: baseline (T0)
Walking ability
The modified Dynamic Gait Index (mDGI) measures the capacity to adapt gait to complex tasks utilizing 8 tasks and 3 facets of performance. The total score range is 0 (minimum) to 64 (maximum, indicating better performance)
Time frame: baseline (T0)
Activities of daily living
The Modified Barthel Index (MBI) is a Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. The total score range is 0 (minimum) to 100 (maximum, indicating no assistance required to complete daily activities)
Time frame: baseline (T0)
Cognitive function
The Frontal Assessment Battery (FAB) is a brief tool that can be used at the bedside or in a clinic setting to assist in discriminating between dementias with a frontal dysexecutive phenotype and Dementia of Alzheimer"s Type. The total score range is 0 (minimum) to 18 (maximum, indicating better performance)
Time frame: baseline (T0)
Balance confidence
The Activities-specific Balance confidence (ABC) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The total score range is 0 (minimum) to 100 (maximum, indicating better balance confidence in daily activities)
Time frame: baseline (T0)
Community integration
The Community Integration Questionnaire (CIQ) is a tool used by researchers to gather information about how connected people are to their communities. The total score range is 0 (minimum) to 29 (maximum, indicating greater integration)
Time frame: baseline (T0)
Gait symmetry (Instrumental index)
Symmetry index of the gait cycle in the AnteroPosterior plan. Higher indexes indicate better performance.
Time frame: baseline T0
Gait regularity (Instrumental index)
Regularity index of the gait cycle in the AnteroPoserior plan. Higher indexes indicate better performance.
Time frame: baseline T0
Started May 2022 (actual). Primary completion is estimated for Apr 2027, 58 months after the start.
Of 335 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 81. This study's planned 58 months is above that.
Counting every sponsor, half of 426 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
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