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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new soft robotic glove | Experimental | which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers |
|
| new soft robotic glove control | Active Comparator | providing 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new soft robotic glove | Device | a soft robotic glove, with dual-chamber actuators |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-month after intervention |
| Modified Ashworth Scale (MAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raymond Tong, PhD | Contact | 39438454 | kytong@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Raymond Tong, PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biomedical Engineering, The Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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It measures the spasticity level of wrist, elbow and finger joint.
| 3-month after intervention |
| Box and Block Test (BBT) | 3-month after intervention |
| Maximum Grip Strength (GRS) | 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 | 3-month after intervention |
| 5Q-5D-5L questionnaire | It is a quality of life questionnaire | 3-month after intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |