Design and Development of a Soft Robotic Glove for Enhanced Task-Oriented Training in Stroke Rehabilitation: Incorporating Dual-Chamber Actuators and Flexible Magnetoelastic Force Sensors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
The goal of this clinical trial is to investigate the feasibility of using the Soft Forearm Robot system for wrist and forearm recovery of hemiplegic subjects suffered from stroke.
Participant will attend 20 training sessions and 3 assessment sessions. This system will leverage electromyography (EMG) signals for intention detection and regulating the movement and the contact for different tasks and objects, ensuring adaptive and precise control for rehabilitation tasks. A systematic clinical study involving sixty stroke patients divided into three groups will evaluate the effectiveness of our innovative design compared to conventional rehabilitation methods. By conducting a randomized controlled trial (RCT), we aim to provide robust evidence on the benefits of our advanced robotic glove design in stroke rehabilitation. We hope our work will significantly advance the field of rehabilitation robotics by improving therapeutic practices, enhancing recovery outcomes, and elevating the quality of life for those facing hand mobility challenges. By integrating new soft robotic hand design with practical application, we aim to create an effective rehabilitation solution for everyone who needs it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chronic stage (6 months post-onset);
- •adequate cognition to follow study instructions;
- •being able to sit for 30 minutes;
- •having detectable residual EMG signals from the affected side's flexor digitorum (FD) and extensor digitorum (ED) muscles, as well as the abductor pollicis brevis (APB) and flexor pollicis longus (FPL); and
- •Modified Ashworth Scale (MAS) score indicating levels of finger spasticity of 0, 1, 1+, 2, and 3 (i.e., 0 = no muscle tone to 3 = increase in tone, difficult in passive movement).
排除标准
- •severe dysphasia,
- •conditions that could hinder study compliance, and
- •certain medical or psychological disorders, such as alcoholism and substance abuse
研究组 & 干预措施
new soft robotic glove
which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers
干预措施: new soft robotic glove (Device)
new soft robotic glove control
providing only flexion and extension like most robotic systems in the clinical setting
干预措施: new soft robotic glove (Device)
regular rehabilitation control
Participants will follow their own regular rehabilitation program.
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: 3-month after intervention
It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
次要结局
- Action Research Arm Test (ARAT)(3-month after intervention)
- Modified Ashworth Scale (MAS)(3-month after intervention)
- Box and Block Test (BBT)(3-month after intervention)
- Maximum Grip Strength (GRS)(3-month after intervention)
- active range of motion (AROM) of fingers(3-month after intervention)
- 5Q-5D-5L questionnaire(3-month after intervention)
研究者
Raymond KY Tong
Professor
Chinese University of Hong Kong