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Идёт набор NCT05993091

Mirror Therapy and Augmented Reality in Stroke Rehabilitation

Без фазы С лечением Stroke Rehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mirror therapy (MT), augmented reality (AR), Control intervention.
Кому может быть актуально
Состояния в реестре: Stroke Rehabilitation. Базовые параметры: 30 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Outcomes of Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation

Обзор

This research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.

Подробное описание

This proposed research is in line with the prioritized need to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.

Current stroke rehabilitation programs, such as MT and AR and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. MT may contribute to bilateral brain coupling by means of mirror visual feedback. It can potentially be an effective priming technique for creating an enriched neuroplastic environment to facilitate motor and functional recovery. AR is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. MT and AR can be complementary for formulating a hybrid regimen. MT has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral and bilateral MT using personally relevant task objects for improving task performance. The goals of this proposed research project will be to (1) compare treatment efficacy between the hybrid approaches of MT preceding AR (MT+AR), AR-based intervention (AR), and dose-matched conventional therapy (CT) on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients, and (2) identify the potential predictors of treatment success using chi-squared automatic interaction detection (CHAID). This project is a single-blinded three-armed randomized controlled trial. The investigators plan to recruit 128 stroke survivors who will be randomly allocated to one of the experimental (MT+AR), comparison (AR), or control (CT) groups. The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. The control group will have 90 minutes of conventional occupational therapy, including 10 minutes of functional practice.

All participants will receive interventions for 90 minutes/day, 3 days/week for 6 weeks. There will be three assessment time points: baseline, immediately after the intervention, and the 3-month follow-up. The primary outcome measures are the upper-extremity subscale of the Fugl-Meyer Assessment and Berg Balance Scale. Under the International Classification of Functioning, Disability and Health (ICF) framework, the investigators will also include sensory impairment, actual arm use, daily activity function, self-efficacy, and quality of life as the secondary outcomes. Analysis of covariance controlling the baseline scores will be used to analyze the immediate and retention effects between treatment groups. After determining the minimal clinically important difference (MCID) in the primary outcomes using anchor- and distribution-based methods, the investigators will further use CHAID to identify the significant predictors and the corresponding cutoff points to differentiate those who have a greater likelihood to respond to treatment. The investigators expect to provide robust evidence for the hybrid regimen of MT-primed AR to boost poststroke patients' recovery in sensory/motor impairment, dysfunction in daily activities, low self-efficacy, and poor health-related quality of life. Specifically, the priming effect of mirror visual feedback is anticipated to be supported by showing a larger effect size in the MT+AR group compared with the AR and CT group. Based on the clinical trial data of our proposed project, the investigators will determine the MCIDs specific to the outcomes of MT/AR and further conduct the CHAID analysis to identify critical predicting factor of treatment success. The findings will update evidence-based stroke care advocated by the Ministry of Health and Welfare and be used to translate the evidence into clinical practice and decision making in precision stroke rehabilitation.

Вмешательства

  • Другое mirror therapy (MT)
    Each participant will practice two different MT protocols: UMT and BMT. During UMT, the affected hand is static, whereas during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements (i.e., shoulder flexion, elbow flexion/extension, forearm pronation/supination, and wrist flexion/extension and circumduction), fine motor movements (i.e., opposition, grasp, and release), and object manipulation (i.e., reachin
  • Другое augmented reality (AR)
    The training program with different levels of difficulty provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg, etc.), activities of daily living training (i.e., reaching to grasp functionally relevant objects), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real p
  • Другое Control intervention
    Participants will perform 90 minutes of therapist-mediated conventional therapy. The treatment protocols will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. Specifically, the affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques will be used to alleviate functional deficits. In addition, the

Первичные конечные точки

  • Fugl-Meyer Assessment (FMA) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Berg Balance Scale (BBS) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
Вторичные конечные точки (7)
  • Revised Nottingham Sensory Assessment (rNSA) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Chedoke Arm and Hand Activity Inventory (CAHAI) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Motor Activity Log (MAL) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Stroke Impact Scale Version 3.0 (SIS 3.0) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Stroke Self-Efficacy Questionnaire (SSEQ) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Goal Attainment Scale (GAS) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
  • Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE) [Срок оценки: Baseline, 6 weeks, and 18 weeks]

Критерии участия

Критерии включения

  • a first-ever unilateral stroke ≥3 months and ≤3 years
  • age between 30 and 80 years (Kwakkel et al., 1999)
  • baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score >10 (Fugl-Meyer et al., 1975)
  • no severe spasticity in any joints of the affected arm (modified Ashworth scale <3) (Charalambous, 2014)
  • ability to follow the instructions of the evaluator and therapists
  • the ability to maintain a step-standing position for at least 30 seconds (Lloréns et al., 2015)
  • ability to walk a minimum of 10 meters, with or without a device (Park et al., 2017)
  • no severe vision impairments or other major neurologic diseases
  • no participation in other studies during the study period
  • willingness to provide informed written consent.

Критерии исключения

  • acute inflammation
  • serious medical problems or poor physical conditions that might be detrimental to study participation.

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 · 5 центров
  • Taipei Hospital, Ministry of Health and Welfare — New Taipei City
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation — New Taipei City
  • Fongyuan Hospital, Ministry of Health and Welfare — Taichung
  • National Taiwan University Hospital — Taipei
  • Wan Fang Hospital, Taipei Medical University — Taipei

Публикации

  • Lin CJ, Lin KC, Lau HY, Hsieh YW, Li YC, Chen WS, Chen CL, Chang YJ, Lee YY, Yao G, Hrong YS, Pan HC, Wu YH, Hsu WL, Kuo CC, Tsai HT, Lin CY, Chang PC. Effects of mirror therapy preceding augmented reality in stroke rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2025 Dec 24;23(1):89. doi: 10.1186/s12984-025-01820-8. PMID 41444616

Идентификаторы

NCT: NCT05993091 · 202303069RINB

Первоисточники (государственные реестры)

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