Stroke Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Biomedical Engineering, The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Raymond Tong, PhD
kytong@cuhk.edu.hk
39438454
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: new soft robotic glove
which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers
Active_comparator: new soft robotic glove control
providing only flexion and extension like most robotic systems in the clinical setting
No_intervention: regular rehabilitation control
Participants will follow their own regular rehabilitation program.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov