Augmented Reality for Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);
研究概览
简要总结
The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients.
详细描述
The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients. The emerging technology of Augmented Reality (AR), has been validated as a promising way to assist the rehabilitation training in Stroke patients. The purpose of this study is to investigate the feasibility of the AR rehabilitation system in a real-world setting. The following questions will be addressed by the present study: (a) How the Augmented reality effects motor function, balance, and functional ambulation in stroke patients? (b) how much and what types of manpower can be saved while maintaining the efficacy of training with the assistance of the AR rehabilitation? (c) how can the contact rate be reduced with the AR training? (d) how do therapists/patients experience the AR training?
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants falling in this category would be recruited into the study.
- •age between 18 to 90 years who are diagnosed with ischemic brain injury, intracerebral hemorrhage shown by magnetic resonance imaging, or computed tomography after the onset of stroke;
- •with motor impairment in the upper limb, lower limb, and/or balance;
- •have no or mild spasticity on the lower limb or upper limb assessed by Modified Ashworth Scale (MAS ≤ 2); and
- •have sufficient cognition to follow the instructions provided by the therapists and the computer.
排除标准
- •Participants fall in this category would be excluded of the study.
- •any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker/joint;
- •have severe shoulder/arm or hip/knee contracture/ pain and;
- •Pregnant women.
结局指标
主要结局
Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);
时间窗: 10 weeks
The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function.
Berg Balance Scale (BBS);
时间窗: 10 weeks
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Functional Ambulation Category (FAC)
时间窗: 10 weeks
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The FAC is a quick visual measurement of walking, is simple to use, easy to interpret. The test has good interrater reliability (κ=.72) and excellent test-retest reliability (k=.950).
次要结局
- Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)(10 weeks)
- User experience (UX) using questionnaires (designed based on UEQ-S)(10 weeks)
- Activities of Daily Living (ADL) using the Barthel Index (BI)(10 weeks)