Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Total Functional Independence Measure (TFIM) Change Scores
研究概览
简要总结
Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.
详细描述
Study design:
Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.
Eligibility criteria:
Inclusion criteria:
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- •Ischemic stroke documented clinically and by neuroimaging.
- •Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- •Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- •Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- •Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- •Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
排除标准
- •Hemorrhagic strokes
- •Patient's with an episode post-stroke seizure or history of epilepsy.
- •Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- •On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- •Stroke patients with implanted pacemakers and defibrillators.
- •Refusal to provide informed consent
结局指标
主要结局
Total Functional Independence Measure (TFIM) Change Scores
时间窗: from baseline to 4-weeks of therapy
The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
次要结局
- Action Research Arm Test (ARAT) Change Scores(baseline to after 4-weeks of therapy)
- Discharge Disposition(after 4 weeks of intervention)