Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery: A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Change scores of Motor Activity Log (MAL)
研究概览
简要总结
We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.
详细描述
Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The participants in each group receive equivalent amounts of treatment.
Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.
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
- 20 Years 至 80 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 more than 6 months
- •Initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to mild movement impairment
- •No severe spasticity in any joints of the affected arm (Modified Ashworth Scale ≤ 2)
- •No serious cognitive impairment (i.e., Mini Mental State Exam score≧ 24)
- •Willing to sign the informed consent form.
排除标准
- •Aphasia that might interfere with understanding instructions
- •Visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia
- •Major health problems or poor physical conditions that might limit participation
- •Currently participation in any other research
- •Previous brain neurosurgery
- •Metallic implants within the brain.
研究组 & 干预措施
Mirror therapy with tDCS
Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.
干预措施: Mirror Therapy with tDCS (Behavioral)
Mirror Therapy
The MT only group will receive a 60-minute MT per session followed by a 30-minute functional training. Participant will go through the same protocol as that for the MT+tDCS and MT+sham tDCS groups with no tDCS presented in setting. This group is for evaluating placebo effect of the present of tDCS application.
干预措施: Mirror Therapy (Behavioral)
Control Intervention
The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training. During the 60-mimute conventional training, interventions will include passive range of movement and muscle tone normalization techniques of the affected arm, and gross motor training (e.g., shoulder ladder activity), fine motor training (e.g., grasping cones), and muscle strength training in a unilateral and bilateral manners. During the 30-minute functional training, the same principles to those in the MT groups will be applied.
干预措施: Control Intervention (Behavioral)
Mirror Therapy with sham-tDCS
Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.
干预措施: Mirror Therapy with sham-tDCS (Behavioral)
结局指标
主要结局
Change scores of Motor Activity Log (MAL)
时间窗: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The clinimetric properties of the MAL in stroke patients have been validated (Uswatte, Taub, Morris, Light, \& Thompson, 2006).
Change scores of Revised Nottingham Sensory Assessment (rNSA)
时间窗: Baseline, and 4 weeks
The rNSA includes tactile sensation, kinesthetic sensation, and stereognosis. The rNSA is reliable measure of sensory function in stroke patients. For tactile sensation, the patient will be asked to indicate whenever he or she feels the test sensation. For kinesthetic sensations, all 3 aspects of movement will be tested: appreciation of movement, its direction and accurate joint position sense. The limb on the affected side of the body will be supported and moved by the examiner in various directions but movement is only at one joint at a time. The patients will be asked to mirror the change of movement with the other limb. For stereognosis, the object will be placed in the patient's hand for a maximum of 30 seconds. Identification is by naming, description or by pair-matching with an identical set. The object may be moved around the affected hand by the examiner. The rNSA has good intrarater and interrater reliability (Lincoln, Jackson, \& Adams, 1998).
Change scores of Fugl-Meyer Assessment (FMA)
时间窗: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Change scores of Wolf Motor Function Test (WMFT)
时间窗: Baseline, 2 weeks, and 4 weeks
The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients (Wolf et al., 2005).
Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
时间窗: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.
次要结局
- Change scores of Kinematic analysis(Baseline, and 4 weeks)
- Change scores of 10-Meter Walk Test (10MWT)(Baseline, 4 weeks)
- Change scores of Stroop test(Baseline, and 4 weeks)
- Change scores of Adelaide Activities Profile (AAP)(Baseline, and 4 weeks, 16 weeks, and 28 weeks)
- Change scores of hand strength(Baseline, 2 weeks, and 4 weeks)
- Change scores of Actigraphy(Baseline, and 4 weeks)
- Change scores of pressure pain threshold(Baseline, and 4 weeks)
