Digital Mirror Therapy in Stroke Rehabilitation

Официальное название

Digital Mirror Therapy in Poststroke Rehabilitation: Efficacy and Patient-reported Facilitators and Barriers to Adherence.

Обзор

Background: While conventional mirror therapy is a Level A recommended rehabilitation for poststroke upper extremity recovery, digital mirror therapy-enabled by augmented reality and computer vision-offers a promising alternative with potential for greater engagement and enriched sensory feedback. However, systematic comparisons of their clinical and physiological benefits, alongside an understanding of patient experiences with digital therapy, are lacking. Objectives: This randomized controlled trial will compare the efficacy of digital versus conventional mirror therapy for upper extremity rehabilitation in people after chronic stroke. The evaluation will focus on three areas: 1) clinical outcomes in motor function and community integration; 2) musculoskeletal physiological mechanisms, assessed through upper extremity muscle co-activation patterns; and 3) patient-reported barriers and facilitators to adherence with the digital technology. Methods: A parallel-group, assessor-blinded randomized controlled trial will be conducted. Participants with chronic stroke will be randomized to receive either digital or conventional mirror therapy three times per week for a total of 10 sessions over 21 days. The quantitative outcomes will be upper extremity function (using clinical scales), community integration (using a dedicated scale), and muscle activation/co-activation patterns during functional tasks (measured via surface electromyography \[EMG\]). The qualitative outcome will be patient-experienced barriers and facilitators, which will be explored through focus groups. Expected Results: This project aims to determine whether digital mirror therapy yields superior clinical outcomes compared to the conventional protocol. We hypothesize that greater improvement in upper extremity motor function will be associated with increased voluntary activation of task-relevant muscles and a reduction in abnormal co-contraction patterns. Furthermore, the qualitative findings will provide insights into the practical facilitators and barriers to patient adherence to digital technological rehabilitation, which will guide its future development and real-world clinical implementation.

Вмешательства

• Поведенческое digital mirror therapy
  In the digital mirror therapy, we will use a self-developed digital visual feedback system to deliver the intervention. We will design 6-8 upper limb functional training tasks for each patient, according to the level of upper extremity functioning. Patients will complete these tasks under the guidance of the investigator during each training session. The digital mirror therapy will be delivered through an augmented reality system with virtual objects and enhanced visual feedback onto the patient
• Поведенческое conventional mirror therapy
  The conventional mirror therapy group will receive the identical dose and structure of training but using a physical mirror. The therapy will be performed using a conventional mirror and common physical objects for task-oriented practice. Both groups will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.

Первичные конечные точки

• Fugl-Meyer Assessment Upper Extremity Scores [Срок оценки: Baseline]
• Fugl-Meyer Assessment Upper Extremity Scores [Срок оценки: After 3 weeks]

Критерии участия

Критерии включения

• diagnosis of ischemic or hemorrhagic stroke more than 6 months;
• age between 18 and 80 years;
• upper limb function rated at levels 2-6 according to the Functional Test for Hemiplegic Extremity Hong Kong Version

Критерии исключения

• any concomitant neurological disease other than stroke;
• signs of cognitive impairment, defined as a score below 6 out of 10 on the Abbreviated Mental Test - Hong Kong Version ;
• or severe spasticity in the hemiparetic upper extremity muscles, with a Modified Ashworth Scale score greater than 2;
• unable to express thoughts effectively through verbal speech or written language.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 2 центра

• Hong Kong Polytechnic University — Гонконг
• Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07460128 · HSEARS20251026004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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