Soft Robot for Rehabilitation of Hand Function After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: new soft robotic glove.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Device new soft robotic glove
a soft robotic glove, with dual-chamber actuators
Primary outcome measures
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Time frame: 3-month after intervention]
Secondary outcome measures (6)
- Action Research Arm Test (ARAT) [Time frame: 3-month after intervention]
- Modified Ashworth Scale (MAS) [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 [Time frame: 3-month after intervention]
- 5Q-5D-5L questionnaire [Time frame: 3-month after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Department of Biomedical Engineering, The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07329075 · 2023.657