Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation: A Cross-Setting Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
研究概览
简要总结
This proposed 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 multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
详细描述
This proposed 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 multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Current stroke rehabilitation programs, such as mirror therapy and augmented reality and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. Mirror therapy 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. Augmented reality is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. Mirror therapy and augmented reality can be complementary for formulating a hybrid regimen. Mirror therapy has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral mirror therapy and bilateral mirror therapy using personally relevant task objects for improving task performance. In addition, the investigators will extend clinic-based practice to practice in the home environment by using telehealth techniques for monitoring performance and providing feedback. The goals of this proposed research project will be to examine the effects of the hybrid intervention of mirror therapy preceding augmented reality or conventional therapy on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients; compare the effects of the hybrid regimen in the clinical versus the home setting; and identify the potential predictors of treatment success using machine learning techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a first-ever unilateral stroke ≥3 months
- •age between 20 and 80 years
- •baseline FMA-UE >10
- •no severe spasticity in any joints of the affected arm MAS < 3)
- •ability to follow the instructions of the evaluator and therapists (Mini-Mental State Examination Score ≥22)
- •ability to stand in a step-standing position for at least 30 seconds
- •ability to walk a minimum of 10 meters with or without a device
- •no severe vision impairments and other major neurologic diseases
- •ability to take part in a rehabilitation intervention program for 9 weeks
- •not participating in other studies over the study period and willingness to provide informed written consent.
排除标准
- •acute inflammation
- •serious medical problems or poor physical conditions that might be detrimental to study participation
结局指标
主要结局
Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
The upper-extremity subscale of the FMA will be used for the assessment of motor impairment. Movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed are scored. Each score is on an ordinal scale of 3 points (0 = cannot perform, 1 = performs partially, 2 = performs fully). The highest score is 66, which indicates optimum recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to study the effects of treatment on separate elements of the upper extremities. The FMA has good reliability, validity, and responsiveness in stroke.
Change from Baseline Berg Balance Scale (BBS) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
The BBS is identified as one of the most widely used evaluation tools of balance across the continuum from acute clinic-based to community-based care. There are 14 items assessing the patient's ability to maintain balance, either statically or with a variety of functional movements, over a given time period. Each score is on a 5-point ordinal scale (0 = inability to complete the task, 4 = independent item completion). The maximum score is 56, representing good balance. The BBS is a reliable and valid tool in assessing balance and functional mobility for stroke.
次要结局
- Revised Nottingham Sensory Assessment (rNSA)(1,3,6,9,21 weeks)
- Chedoke Arm and Hand Activity Inventory (CAHAI)(1,3,6,9,21 weeks)
- Motor Activity Log (MAL)(1,3,6,9,21 weeks)
- modified Rankin scale(1,3,6,9,21 weeks)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(1,3,6,9,21 weeks)
- Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)(1,3,6,9,21 weeks)
- Possible Adverse Response(through study completion, an average of 21 weeks)
- Montreal Cognitive Assessment(1 and 6 weeks)