Soft Robot for Rehabilitation of Hand Function After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: new soft robotic glove

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Tong, PhD; Phone Number: 39438454; Email: kytong@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Biomedical Engineering, The Chinese University of Hong Kong
    • Contact: Raymond Kai-yu Tong, PhD; Phone Number: +852 3943 8454; Email: kytong@cuhk.edu.hk
    • Principal Investigator: Raymond Kai-yu Tong, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: new soft robotic glove; which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers	Device: new soft robotic glove; a soft robotic glove, with dual-chamber actuators
Active Comparator: new soft robotic glove control; providing only flexion and extension like most robotic systems in the clinical setting	Device: new soft robotic glove; a soft robotic glove, with dual-chamber actuators
No Intervention: regular rehabilitation control; Participants will follow their own regular rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Raymond Tong, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: upper limb; stroke rehabilitation; soft robotics
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2023.657

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No