Soft Robot for Rehabilitation of Hand Function After Stroke

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Stroke

Treatments: Device: new soft robotic glove

Study type: Interventional

Funder types: Other

Identifiers

NCT07329075

2023.657

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• severe dysphasia,
• conditions that could hinder study compliance, and
• certain medical or psychological disorders, such as alcoholism and substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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60 participants in 3 patient groups

new soft robotic glove

Experimental group

Description:

which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers

Treatment:

Device: new soft robotic glove

new soft robotic glove control

Active Comparator group

Description:

providing only flexion and extension like most robotic systems in the clinical setting

Treatment:

Device: new soft robotic glove

regular rehabilitation control

No Intervention group

Description:

Participants will follow their own regular rehabilitation program.