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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
a soft robotic glove, with dual-chamber actuators
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGFugl-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
Time frame: 3-month after intervention
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
Time frame: 3-month after intervention
Modified Ashworth Scale (MAS)
It measures the spasticity level of wrist, elbow and finger joint.
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
range of motion is a measurement to identify how far the person's joints range can move in flexion/extension
Time frame: 3-month after intervention
5Q-5D-5L questionnaire
It is a quality of life questionnaire
Time frame: 3-month after intervention
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