Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Robotic Assisted Gait Training with G-EO system.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis, Stroke, Parkinson Disease, Acquired Brain Injury. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
Обзор
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
Подробное описание
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.
Вмешательства
- Устройство 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.
Первичные конечные точки
- Change in gait speed [Срок оценки: 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]
Вторичные конечные точки (11)
- Trunk control [Срок оценки: baseline (T0)]
- Mobility [Срок оценки: baseline (T0)]
- Strength [Срок оценки: baseline (T0)]
- Walking Endurance [Срок оценки: baseline (T0)]
- Walking ability [Срок оценки: baseline (T0)]
- Activities of daily living [Срок оценки: baseline (T0)]
- Cognitive function [Срок оценки: baseline (T0)]
- Balance confidence [Срок оценки: baseline (T0)]
- Community integration [Срок оценки: baseline (T0)]
- Gait symmetry (Instrumental index) [Срок оценки: baseline T0]
- Gait regularity (Instrumental index) [Срок оценки: baseline T0]
Критерии участия
Критерии включения
- 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;
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Don Gnocchi Foundation — Milan
Идентификаторы
NCT: NCT05493514 · 03_06/04/2022