Soft Robot for Rehabilitation of Hand Function After Stroke

Официальное название

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

Обзор

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.

Вмешательства

• Устройство new soft robotic glove
  a soft robotic glove, with dual-chamber actuators

Первичные конечные точки

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Срок оценки: 3-month after intervention]

Вторичные конечные точки (6)

• Action Research Arm Test (ARAT) [Срок оценки: 3-month after intervention]
• Modified Ashworth Scale (MAS) [Срок оценки: 3-month after intervention]
• Box and Block Test (BBT) [Срок оценки: 3-month after intervention]
• Maximum Grip Strength (GRS) [Срок оценки: 3-month after intervention]
• active range of motion (AROM) of fingers [Срок оценки: 3-month after intervention]
• 5Q-5D-5L questionnaire [Срок оценки: 3-month after intervention]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Department of Biomedical Engineering, The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07329075 · 2023.657

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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