Soft Robot for Rehabilitation of Hand Function After Stroke
NCT ID: NCT07329075
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2026-01-31
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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new soft robotic glove
which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers
new soft robotic glove
a soft robotic glove, with dual-chamber actuators
new soft robotic glove control
providing only flexion and extension like most robotic systems in the clinical setting
new soft robotic glove
a soft robotic glove, with dual-chamber actuators
regular rehabilitation control
Participants will follow their own regular rehabilitation program.
No interventions assigned to this group
Interventions
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new soft robotic glove
a soft robotic glove, with dual-chamber actuators
Eligibility Criteria
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Inclusion Criteria
* 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
* conditions that could hinder study compliance, and
* certain medical or psychological disorders, such as alcoholism and substance abuse
18 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Raymond KY Tong
Professor
Principal Investigators
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Raymond Tong, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023.657
Identifier Type: -
Identifier Source: org_study_id
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