The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in Wolf's Motor Function Test (WMFT)
研究概览
简要总结
The aim of the study is to evaluate whether a graded rehabilitation approach including Implicit and explicit motor imagery training and mirror therapy is more effective than other treatments commonly provided in a neuro-rehabilitation department.
详细描述
Graded Motor Imagery is a graded approach recently proposed for treating chronic pain patients. It included three subsequent steps:
- Implicit Motor Imagery training (IMI), using a body part laterality discrimination task
- Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements
- Mirror box therapy, using a 35x40 cm mirror,
We are transferring this approach into stroke rehabilitation in order to improve patients' upper limb motor functions.
All the patients, in both groups, will be training 2 hours a day, 5 days/week for 4 weeks. The first hour is standard treatment, the clinician in charge will decide treatment's priorities and the aim(s) of the treatment for each specific patient. The second hour will be focused on patient's upper limb function.
The treatment group will be treated accordingly to the GMI protocol. The control group will receive a second hour of standard treatment, centred on the upper limb. Standard treatments are decided by the interdisciplinary team and might include motor rehabilitation, bilateral arm training, virtual reality training or occupational therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic or hemorrhagic stroke within a year from the event;
- •age of participant between 21 and 85 years old;
- •absence of apraxia or global aphasia;
- •Mini-Mental State Examination score >23.
排除标准
- •Presence of other neurological or orthopaedic disorders affecting upper extremity motor function,
- •Significant spasticity defined as a score ≥ 24 total points at Tardieu Rating Scale (TRS)
结局指标
主要结局
Change in Wolf's Motor Function Test (WMFT)
时间窗: before and after the 4-weeks treatment
It includes 17 different tasks, which assess shoulder, elbow, wrist function and manual ability. For each task, a qualitative mark is given and time needed to complete the action is recorded.
Change in Fugl Meyer Assessment Scale for upper extremity (FMA)
时间窗: Before and after the 4-weeks treatment
We use the Upper Extremity session of the scale. The scale evaluates patient's balance, passive and active movements of shoulder, elbow, wrist and hand. It also evaluates different types of grips. Sense of position and ability to detect light touches are also evaluated.
次要结局
- Change in Functional Independence Measure (FIM)(before and after the 4-weeks treatment)
- Change in Transcranial Magnetic Stimulation (TMS)(before and after the 4-weeks treatment)
研究者
Andrea Polli
MSc
IRCCS San Camillo, Venezia, Italy