Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fugl-Meyer (Motor Function - Upper Extremity Subscale)
研究概览
简要总结
This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients.
详细描述
The aim of the current study is to investigate whether motor training in chronic stroke patients can change their abnormal flexion synergy. The investigators will study chronic stroke patients , who are defined as patients that sustained a stroke at least 6 months prior to our testing date.
Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC), finger dexterity, and hand posture.
Prior to intervention, participants will have a baseline assessment including clinical tests, MVC, the individuation task, and the configuration task. Following the baseline assessment patients will receive intervention, training on the configuration task for 5 consecutive days. On the sixth day and as a one week follow-up after, subjects will have a post-intervention assessment containing the same tests performed in baseline.
This design will allow us to determine speed and accuracy during the configuration task, the individuation index, and possible changes in abnormal flexion synergy.
We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided to make it one arm due to the number of participants we were able to recruit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and older
- •Ischemic stroke greater than six months ago, confirmed by CT or MRI
- •Residuals unilateral upper extremity weakness
- •Ability to give informed consent and understand the tasks involved.
- •Appearance of Flexion synergy in hand.
- •Ability to extent finger at least for 5 degrees.
排除标准
- •Cognitive impairment, with score on Montreal Cognitive assessment (MoCA) ≤ 20
- •History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease)
- •Contraindication to tDCS (deep brain stimulators or other metal in the head, skull defect, pacemaker)
- •Inability to sit in a chair and perform upper limb exercises for one hour at a time
- •Participation in another upper extremity rehabilitative therapy study or tDCS study during the study period
- •Terminal illness
- •Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments
- •Pregnancy
- •Severe Neglect
结局指标
主要结局
Fugl-Meyer (Motor Function - Upper Extremity Subscale)
时间窗: Change from Baseline Impairment Index at 2 weeks
Assesses functional mobility using observational methods. It is a 66 item measure. Its items are scored on a 3-point ordinal scale. 0: Cannot perform 1. performs partially 2. performs fully Possible score range from 0 - 66
Action Research Arm Test (ARAT)
时间窗: Change from Baseline ARAT at 2 weeks
Assesses upper limb functioning in activities of daily living using observational methods. It is a 19 item measure divided into a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Possible score range of 0 to 57; higher scores equal less impairment.
Accuracy (Euclidian norm)
时间窗: Change from Baseline Accuracy at 2 weeks
The deviation of each finger from a target amount of force generation during a set of finger movements.
Individuation Index
时间窗: Change from Baseline Individuation Index at 2 weeks
The relationship between forces (in Newton) in active vs passive fingers during a set of isolated finger movements. It is a measure of finger independence.
次要结局
- Execution Time(Change from Baseline Execution Time at 2 weeks)
- Modified Ashworth scale(Change from Baseline Modified Ashworth Scale at 2 weeks)
- Semmes Weinstein Monofilament Examination (SWME)(Change from Baseline SWME at 2 weeks)