Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.
详细描述
This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of stroke in cortical regions
- •time since stroke less than 3 months
- •initial motor part of UE of FMA score ranging from 24 to 52
- •no serious cognitive impairment
排除标准
- •visual impairments
- •major health problems or poor physical conditions
- •currently participation in any other
研究组 & 干预措施
mirror therapy treatment
Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
干预措施: MT with low-intensity group (MT-LI) (Behavioral)
mirror therapy treatment
Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
干预措施: MT with moderate-intensity group (Behavioral)
mirror therapy treatment
Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
干预措施: Mirror therapy with high intensity group (Behavioral)
control intervention group
The part of this project will involve 1 treatment groups:control intervention group (CI)
干预措施: Control intervention group (Behavioral)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks
ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
Motor Activity Log (MAL)
时间窗: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.
ABILHAND Questionnaire
时间窗: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.
Adelaide Activities Profile (AAP)
时间窗: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.
Fugl-Meyer Assessment (FMA)
时间窗: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
次要结局
- Functional magnetic resonance imaging (fMRI)(Baseline and change of fMRI at 4 weeks)
- Physiological marker measures(Baseline and change from baseline in physiological marker measures at 4 weeks)