Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System: an Observational Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in gait speed
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Change in gait speed
时间窗: 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
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.
次要结局
- Cognitive function(baseline (T0))
- Walking ability(baseline (T0))
- Trunk control(baseline (T0))
- Strength(baseline (T0))
- Walking Endurance(baseline (T0))
- Gait symmetry (Instrumental index)(baseline T0)
- Gait regularity (Instrumental index)(baseline T0)
- Mobility(baseline (T0))
- Activities of daily living(baseline (T0))
- Balance confidence(baseline (T0))
- Community integration(baseline (T0))