StrokeNCT07329075
Soft Robot for Rehabilitation of Hand Function After Stroke
A study testing new soft robotic glove in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- new soft robotic glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- severe dysphasia,
- conditions that could hinder study compliance, and
- certain medical or psychological disorders, such as alcoholism and substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Raymond Kai-yu Tong, PhD, +852 3943 8454, kytong@cuhk.edu.hk
Raymond Kai-yu Tong, PhD
About this study
Official title: 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
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.
- Conditions
- Stroke
- Being tested
- new soft robotic glove
- Keywords
- upper limb, stroke rehabilitation, soft robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new soft robotic gloveDevice
a soft robotic glove, with dual-chamber actuators
| Study group | Role | What they receive |
|---|---|---|
| new soft robotic glove | Experimental | which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers Receives: Device: new soft robotic glove |
| new soft robotic glove control | Active comparator | providing only flexion and extension like most robotic systems in the clinical setting Receives: Device: new soft robotic glove |
| regular rehabilitation control | No intervention | Participants will follow their own regular rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
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
Measured: 3-month after intervention
Secondary outcomes (6)
Action Research Arm Test (ARAT)
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Measured: 3-month after intervention
Modified Ashworth Scale (MAS)
It measures the spasticity level of wrist, elbow and finger joint.
Measured: 3-month after intervention
Box and Block Test (BBT)
Measured: 3-month after intervention
Maximum Grip Strength (GRS)
Measured: 3-month after intervention
active range of motion (AROM) of fingers
range of motion is a measurement to identify how far the person's joints range can move in flexion/extension
Measured: 3-month after intervention
5Q-5D-5L questionnaire
It is a quality of life questionnaire
Measured: 3-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Tong, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329075
- Sponsor's protocol ID
- 2023.657
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07329075
- Acronym / sponsor ID
- 2023.657
- Conditions
- Stroke
- Keywords
- upper limb, stroke rehabilitation, soft robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| new soft robotic glove | Experimental | Device: new soft robotic glovewhich allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers |
| new soft robotic glove control | Active comparator | Device: new soft robotic gloveproviding only flexion and extension like most robotic systems in the clinical setting |
| regular rehabilitation control | No intervention | –Participants will follow their own regular rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- severe dysphasia,
- conditions that could hinder study compliance, and
- certain medical or psychological disorders, such as alcoholism and substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new soft robotic glovea soft robotic glove, with dual-chamber actuators | Device | new soft robotic glove, new soft robotic glove control |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: 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
6 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: 3-month after intervention
Modified Ashworth Scale (MAS)
Time frame: 3-month after intervention
Box and Block Test (BBT)
Time frame: 3-month after intervention
Maximum Grip Strength (GRS)
Time frame: 3-month after intervention
active range of motion (AROM) of fingers
Time frame: 3-month after intervention
5Q-5D-5L questionnaire
Time frame: 3-month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Tong, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new soft robotic glove in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Tong, PhD (39438454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: 3-month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.