Soft Robot for Rehabilitation of Hand Function After Stroke

NCT07329075 | Recruiting

• 1 other identifier: 2023.657
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upper limb; stroke rehabilitation; soft robotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Action Research Arm Test (ARAT)

  3-month after intervention

• Modified Ashworth Scale (MAS)

  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

  3-month after intervention

Study Arms (3)

new soft robotic glove

EXPERIMENTAL

which allows the pressure of the dual-chamber actuators to achieve full DOF for the thumb and fingers

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

Device: new soft robotic glove

regular rehabilitation control

NO INTERVENTION

Participants will follow their own regular rehabilitation program.

Interventions

new soft robotic glove DEVICE

a soft robotic glove, with dual-chamber actuators

new soft robotic glove; new soft robotic glove control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• severe dysphasia,
• conditions that could hinder study compliance, and
• certain medical or psychological disorders, such as alcoholism and substance abuse

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond Tong, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

39438454; kytong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

HK (1)