REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Ashworth Scale measured by physiotherapists
研究概览
简要总结
The goal of the Rehabotics project is the development of a comprehensive rehabilitation system to provide highly individualized treatment of upper limb function in patients with motor disorders due to acquired brain damage (eg stroke) or neurodegenerative disease (eg sclerosis), having as central pillar the integration of robotic systems and support functions. A key part of the proposed system is the development and evaluation of an innovative robotic extraskeletal device that will be applied in the form of a glove to the diseased limb of the neurological patient.
The proposed robotic system:
- will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
- will offer a specialized rehabilitation program (therapeutic exercises, retraining of functional movements and support of daily activities) through an interactive virtual environment provided by the Rehabotics platform.
The aim is to provide an environment for the provision of a high level of treatment and support services to patients with hand mobility disorders which will take place both in the clinical environment and in the patient's home through telemedicine applications.
To demonstrate the efficiency of the proposed system, Rehabotics will be applied on post-stoke patients for rehabilitation while also using a control group receiving traditional physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke pathology,
- •Ashworth Scale ≤ 3,
- •6 months maximum time since the incident
排除标准
- •Presence of neurological pathologies that affect hand motion (Parkinson's disease)
- •Musculoskeletal deficits that affect normal finger range of motion (e.g. finger fractures, joint stiffness/pain, arthritis that affect joint motion)
- •Ashworth Scale > 3,
- •Over 6 months since the incident
结局指标
主要结局
Ashworth Scale measured by physiotherapists
时间窗: Change from baseline to 5 weeks
This outcome aims to explore the therapeutic potential of Rehabotics in stroke rehabilitation, demonstrating improved hand motor function through the integration of robotics and Augmented Reality games, measured by Ashworth Scale \[AS\]. The AS is a key instrument for evaluating spasticity in individuals with upper extremity mobility challenges during rehabilitation. This assessment uses a scoring system from 0 to 4, where higher scores denote greater difficulty in finger movement, and lower scores indicate easier finger movement.
Box and Block Test score measured by physiotherapists
时间窗: Change from baseline to 5 weeks
This outcome aims to explore the therapeutic potential of Rehabotics in stroke rehabilitation, demonstrating improved hand motor function through the integration of robotics and Augmented Reality games, measured by the Box and Block Test \[BBT\] score. The BBT consists of a wooden box divided into two compartments by a partition and includes 150 blocks. During the BBT administration, the patient is instructed to move as many blocks as possible, one by one, from one compartment to the other within 60 seconds. The higher the number of blocks moved indicate better manual dexterity.
次要结局
- Device Evaluation Satisfaction utilizing questionnaires for patients(Administered in the 5th week)
- Device Evaluation Satisfaction utilizing questionnaires for physiotherapists(1 year)
研究者
Pantelis Syringas
Principal Investigator
National Technical University of Athens