Soft Robot for Rehabilitation of Hand Function After Stroke

NCT ID: NCT07329075

Last Updated: 2026-01-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type EXPERIMENTAL

new soft robotic glove

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

new soft robotic glove

Intervention Type DEVICE

a soft robotic glove, with dual-chamber actuators

regular rehabilitation control

Participants will follow their own regular rehabilitation program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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new soft robotic glove

a soft robotic glove, with dual-chamber actuators

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Raymond Tong, PhD

Role: CONTACT

Facility Contacts

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Raymond Kai-yu Tong, PhD

Role: primary

+852 3943 8454

Other Identifiers

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2023.657

Identifier Type: -

Identifier Source: org_study_id

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