Stroke
Conditions
Keywords
upper limb, stroke rehabilitation, soft robotics
Brief 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.
Interventions
DEVICEnew soft robotic glove
a soft robotic glove, with dual-chamber actuators
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale (MAS) | 3-month after intervention | It measures the spasticity level of wrist, elbow and finger joint. |
| Box and Block Test (BBT) | 3-month after intervention | — |
| Action Research Arm Test (ARAT) | 3-month after intervention | The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning |
| active range of motion (AROM) of fingers | 3-month after intervention | range of motion is a measurement to identify how far the person's joints range can move in flexion/extension |
| 5Q-5D-5L questionnaire | 3-month after intervention | It is a quality of life questionnaire |
| Maximum Grip Strength (GRS) | 3-month after intervention | — |
Countries
Hong Kong
Contacts
Primary ContactRaymond Tong, PhD
Outcome results
None listed