Clinical trial NCT05493514: Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
Official title: Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Stroke
Parkinson Disease
Acquired Brain Injury
Keywords: Multiple Sclerosis
Stroke
Parkinson Disease
Acquired Brain Injury
Robotic
End-effector
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Neurological Disease, in particular people with Multiple Sclerosis (MS), Parkinson Disease (PD) and Stroke

Brief summary: 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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in gait speed
timeFrame: 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
Secondary outcomes:
measure: Trunk control
timeFrame: baseline (T0)
measure: Mobility
timeFrame: baseline (T0)
measure: Strength
timeFrame: baseline (T0)
measure: Walking Endurance
timeFrame: baseline (T0)
measure: Walking ability
timeFrame: baseline (T0)
measure: Activities of daily living
timeFrame: baseline (T0)
measure: Cognitive function
timeFrame: baseline (T0)
measure: Balance confidence
timeFrame: baseline (T0)
measure: Community integration
timeFrame: baseline (T0)
measure: Gait symmetry (Instrumental index)
timeFrame: baseline T0
measure: Gait regularity (Instrumental index)
timeFrame: baseline T0
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Don Gnocchi Foundation
Study officials:
References: