NCT07000019尚未招募不适用
Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Philadelphia Naming Test
研究概览
简要总结
The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are:
- To determine the extent to which this combined treatment can improve language.
- To determine the extent to which the combined treatment can improve arm movements.
Researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 18-90 years of age.
- •Right-handed prior to stroke
- •English-speaking (monolingual)
- •History of single left-hemisphere stroke at least 6 months prior to enrollment
- •Presence of aphasia and naming deficits on Western Aphasia Battery (WAB-R)
- •Comprehension score above 4 on WAB-R
- •Unilateral upper limb paresis (Fugl-Meyer Upper Extremity score <56)
- •Documentation of signed Informed Consent by the study participant.
排除标准
- •Diagnosis or history of speech impairment prior to stroke
- •Severely limited speech output (score below 2 on spontaneous speech portion of WAB-R)
- •Inability to perform screening tasks due to severe language and/or cognitive impairment
- •Condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture)
- •Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator
结局指标
主要结局
Philadelphia Naming Test
时间窗: Baseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor Assessment
时间窗: Baseline to 1 week post-treatment
次要结局
- Western Aphasia Battery-Revised Aphasia Quotient(Baseline to 4 weeks post-treatment)
- Box and Blocks Test(Baseline to 1 and 4 weeks post-training)
- Apraxia Battery for Adults(Baseline to 1 and 4 weeks post-training)
- Stroke and Aphasia Quality of Life Scale-39(Baseline to 1 and 4 weeks post-training)
- Apraxia of Speech Rating Scale(Baseline to 1 and 4 weeks post-training)
研究者
Tomoko Kitago, MD
Assistant Professor of Neurology
New York Medical College
研究点 (2)
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