Evaluation of the Use of Exoskeleton Systems for Upper Limb Rehabilitation in Neurological Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
Acquired cerebrovascular trauma is the third most common cause of disability worldwide, resulting in long-term disability, limitation of activities of daily living, and reduced social participation. It is estimated that, within three months of the acute event, a high percentage of patients do not recover full function. 93% of these disabilities concern the upper limb.
To induce optimal functional reorganization after the acute cerebrovascular events or neurodegenerative diseases affecting the central nervous system, robotic assistance allows intensive exercises with specific therapeutic purposes. Indeed, they enable an intensive, repetitive, and customizable therapeutic program that is in line with the principles underlying motor learning.
Clinical investigation is needed to assess the efficacy of the proposed new technologies (AGREE and FEXO exoskeleton) and to guide subsequent developmental steps. Therefore, an exploratory clinical study is proposed to evaluate usability, tolerability, and safety, as well as to assess the effectiveness of the new technologies.
The primary objective of this study is to examine the safety and tolerability of the new active exoskeletons for upper extremity rehabilitation and validate them in a controlled environment. Furthermore, efficacy will be examined as the secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 85 years;
- •motor deficit of the upper limb induced by neurological diseases (e.g., stroke, multiple sclerosis);
- •time since the acute event of at least one month;
- •Trunk Control Test score ≥ 48.
排除标准
- •global aphasia;
- •presence of cognitive impairment;
- •severe unilateral spatial neglect;
- •Box and Block test < 1;
- •Ashworth scale score ≥ 4;
- •total or severe impairment of visual acuity;
- •instability of clinical parameters or presence of severe comorbidities;
- •inadequate anthropometric measurements;
- •presence of any serious condition that may affect participation in the study (e.g., oncological, hepatic/renal, immune, metabolic/endocrine, psychiatric, respiratory or infectious disorders);
- •inability to comply with the protocol or to give informed consent.
结局指标
主要结局
System Usability Scale (SUS)
时间窗: up to 5 weeks
SUS is used to measure how easy or difficult the proposed system is to use
次要结局
- Modified Ashworth Scale (MAS)(up to 5 weeks)
- Motricity Index (MI)(up to 5 weeks)
- Fugl-Meyer Assessment Scale (FMA-UE)(up to 5 weeks)
- Action Research Arm Test (ARAT)(up to 5 weeks)
- Technology Assessment Methods (TAM)(up to 5 weeks)
- Smoothness described by the Teulings's index (TI)(up to 5 weeks)
- Event-Related Desynchronization and Synchronization (ERD/ERS) of the μ and β rhythms(up to 5 weeks)
- Virtual Reality Questionnaire (VR)(up to 5 weeks)
- Box and Block Test (BBT)(up to 5 weeks)
- Visual Analogue Scale (VAS)(up to 5 weeks)
- Nine Hole Peg Test (9HPT)(up to 5 weeks)
- Number of Peaks (#Peaks) of the speed profile(up to 5 weeks)
- The absolute hand path error (e)(up to 5 weeks)