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NCT Number: NCT07329075

Soft Robot for Rehabilitation of Hand Function After Stroke

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Raymond Kai-yu Tong, PhD

CONTACT

[email protected]

+852 3943 8454

Raymond Kai-yu Tong, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

new soft robotic glove

Device

a soft robotic glove, with dual-chamber actuators

Primary outcomes

  1. Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    Time frame: 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 outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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

  2. Modified Ashworth Scale (MAS)

    Time frame: 3-month after intervention

    It measures the spasticity level of wrist, elbow and finger joint.

  3. Box and Block Test (BBT)

    Time frame: 3-month after intervention

  4. Maximum Grip Strength (GRS)

    Time frame: 3-month after intervention

  5. active range of motion (AROM) of fingers

    Time frame: 3-month after intervention

    range of motion is a measurement to identify how far the person's joints range can move in flexion/extension

  6. 5Q-5D-5L questionnaire

    Time frame: 3-month after intervention

    It is a quality of life questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Tong, PhD

CONTACT

[email protected]

39438454

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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