Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Fugl-Meyer Upper Extremity (FM-UE)
研究概览
简要总结
Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 21 years
- •Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
- •No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
- •Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
- •Ability to give informed consent and understand the tasks involved.
排除标准
- •Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
- •Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
- •Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
- •Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤
- •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).
- •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 during the study period.
- •Terminal illness
- •Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
研究组 & 干预措施
Device-assisted therapy
30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation
干预措施: Device-assisted therapy (Behavioral)
Therapy-based occupational therapy
30 hours of conventional occupational therapy that emphasizes task-oriented training.
干预措施: Therapy-based occupational therapy (Behavioral)
结局指标
主要结局
Fugl-Meyer Upper Extremity (FM-UE)
时间窗: from baseline to day 3 post-training
Change in arm impairment, measured by FM-UE
次要结局
- Fugl-Meyer Upper Extremity (FM-UE)(from baseline to day 90 post-training)