Multimodal Sensory Feedback and Mirror Therapy for Stroke Rehabilitation

Официальное название

Neural Mechanisms and Efficacy of Multimodal Sensory Feedback Augmentation on Mirror Therapy for Stroke Rehabilitation

Обзор

The goal of this clinical trial is to investigate the clinical and neurophysiological effects of a novel multimodal sensory feedback mirror therapy in stroke survivors with upper extremity hemiparesis , aged between 20 and 85 years. The main questions it aims to answer are: 1. Does Multimodal Augmented Mirror Therapy (MAF-MT) lead to significantly greater improvements in functional recovery compared to unimodal digital mirror visual feedback mirror therapy (MVF-MT) or traditional mirror therapy (TMT) ? 2. What are the underlying neurophysiological changes in brain activation (mu rhythm desynchronization) and intermuscular coordination patterns associated with this hybridized feedback approach? Researchers will compare the MAF-MT group (receiving digital mirror visual feedback with multimodal sensory feedback) to the MVF-MT group (digital mirror feedback only) and the TMT group (traditional mirror therapy using the standard mirror box) to see if the integration of multimodal feedback leads to superior functional and brain acitivity outcomes. Participants will undergo eligibility screening including assessments of motor impairment and cognitive status. They will participate in 20 sessions of intervention, consisting of approximately 75 minutes of assigned therapies. They will receive specific sensory intervention depending on group assignment and complete evaluation (described in Outcome Measures) before the intervention, immediately after, and at a one-month follow-up

Вмешательства

• Поведенческое MAF-MT: Multimodal Augmeneted Mirror Therapy
  MAF-MT combines somatosensory and auditory feedback with digital mirror visual feedback, providing an overall augmented sensory feedback with the goal to improve sense of embodiment (SoE) during mirror therapy.
• Поведенческое Traditional Mirror Therapy
  TMT uses traditional mirror boxes to provide the mirror visual feedback of the less affected hand during mirror therapy
• Поведенческое MVF-MT: Digital Mirror Visual Feedback Mirror Therapy
  MVF-MT provides real-time digital image of the less affected hand as the mirror visual feedback during mirror therapy

Первичные конечные точки

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) [Срок оценки: Baseline, 4 weeks, and 8 weeks]

Вторичные конечные точки (12)

• Wolf Motor Function Test (WMFT) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Modified Ashworth Scale (MAS) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Medical Research Council scale (MRC) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Nottingham Extended Activities of Daily Living Scale (NEADL) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• EQ-5D-5L [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Functional Abilities Confidence Scale (FACS) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Stroke Self-Efficacy Questionnaire (SSEQ) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Daily Living Self-Efficacy Scale (DLSES) [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Chinese version [Срок оценки: Baseline, 4 weeks and 8 weeks]
• The Embodiment Questionnaires [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Electroencephalography (EEG)-Event-related desynchronization (ERD) of sensorimotor mu rhythm of both hemispheres [Срок оценки: Baseline, through study completion, an average of 1 year]

Критерии участия

Критерии включения

• At least 3 months post-onset of a unilateral stroke
• Age between 20 and 85 years
• An initial Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score between 18 and 56
• Ability to follow study instructions, as determined by a Montreal Cognitive Assessment (MoCA) score ≥ 18
• No concurrent participation in other neurorehabilitation studies or drug clinical trials

Критерии исключения

• Severe neglect, as measured by the line bisection test
• Uncontrolled major medical conditions, such as uncontrolled hypertension or heart failure, or concomitant neurological conditions, for example, dementia, Parkinson's disease, brain tumors, or other brain conditions
• Severe pain, swelling, spasticity or contractures in affected arms that prevent movement practice and assessments.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Tzu Chi Hospital — New Taipei City

Идентификаторы

NCT: NCT07426354 · 14-IRB040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗