Longitudinal Pilot Study on the Feasibility of Integrating Gait Training Through a Novel Over-ground Wearable Robotic System to Traditional Rehabilitation in People with Pyramidal Hemisyndromes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in 6 Minute Walk Test (6MWT)
研究概览
简要总结
Over-ground exoskeletons for gait rehabilitation are studied enough in people suffering spinal cord injury, and its clinical use is escalating in the industrialized countries. Nevertheless, studies on gait rehabilitation through exoskeletons in subjects with Pyramidal Hemisyndrome (PH) are recognized by GRADE as Low Quality of evidence.
This interventional longitudinal pilot study is aimed to investigate the feasibility, clinical effects, and compliance (from the experienced therapists (Indego Specialists)' point of view) of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH in the clinical practice.
Two substudies will be conducted with the following aims: to explore changes in the gait pattern and muscle activity following Indego-assisted gait rehabilitation through the kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs; to identify prognostic factors for walking recovery, investigating also the effect of the treatment on functional connectivity through the electroencephalographic (EEG) analysis.
In order to satisfy the study aims, 30 subjects with PH and walking impairment will be recruited and assessed both clinically and instrumentally (in case of substudies) at the beginning (T0) and the end (T1) of the treatment period.
详细描述
The primary objective of this interventional longitudinal pilot study is to investigate the feasibility of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH associated with the traditional rehabilitation.
Secondary objectives of the study are:
- To explore the clinical effects of the treatment;
- To evaluate the feasibility of implementing this system in clinical practice from experienced therapists (Indego Specialists)' point of view.
Two Sub-Studies (SS) will be conducted with the following aims:
- Kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs in order to evaluate changes in the gait pattern and muscle activity following gait rehabilitation through an over-ground wearable exoskeleton system;
- Electroencephalographic (EEG) analysis in order to: identify prognostic factors for walking recovery; investigate the effect of the treatment on functional connectivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single or multiple unilateral Cerebral Stroke
- •Mild / moderate Traumatic Brain Injury
- •Brain Tumor Benign
- •Possibility to keep the upright position for at least 1 minute with good cardiovascular compensation and:
- •With double support and supervision;
- •With double support without supervision;
- •With single support and supervision;
- •With single support without supervision;
- •With assistance not exceeding 50%;
- •With supervision only.
排除标准
- •Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
- •Refusal or impossibility to provide informed consent
- •Impossibility to wear the robot:
- •for serious functional limitations in the coxo-femoral joints and knees;
- •marked hyper tone with sudden spasms in flexion;
- •Modified Ashworth Scale > 3;
- •weight over 113 Kg;
- •height less than 155 cm or higher than 195 cm;
- •hip width greater than 46 cm.
- •Sever cardio-respiratory co-morbidities.
结局指标
主要结局
Changes in 6 Minute Walk Test (6MWT)
时间窗: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded.
次要结局
- Change in Functional Ambulation Classification (FAC)(Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).)
- Change in 10 Meter Walk Test (10MWT)(Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).)
- Change in Timed Up And Go (TUG)(Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).)
- Change in Barthel Index (BI)(Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).)
- Change in Motricity Index (MI)(Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).)
- Change in Trunk Control Test (TCT)(Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).)
- Change in Modified Ashworth Scale (MAS)(Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).)
- Change in Walking Handicap Scale (WHS)(Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).)