Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Assisted Gait Training with G-EO system.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in gait speed [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]
Secondary outcome measures (11)
- Trunk control [Time frame: baseline (T0)]
- Mobility [Time frame: baseline (T0)]
- Strength [Time frame: baseline (T0)]
- Walking Endurance [Time frame: baseline (T0)]
- Walking ability [Time frame: baseline (T0)]
- Activities of daily living [Time frame: baseline (T0)]
- Cognitive function [Time frame: baseline (T0)]
- Balance confidence [Time frame: baseline (T0)]
- Community integration [Time frame: baseline (T0)]
- Gait symmetry (Instrumental index) [Time frame: baseline T0]
- Gait regularity (Instrumental index) [Time frame: baseline T0]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Don Gnocchi Foundation — Milan
Identifiers
NCT: NCT05493514 · 03_06/04/2022