Guided Versus Directed Training in Acute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
研究概览
简要总结
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of acute stroke
- •admission to acute inpatient rehabilitation
- •impairment in cognitive functions (as indicated by 14-item Executive Interview ≥ 3)
排除标准
- •diagnosis of dementia in the medical record
- •inability to follow two-step commands 80% of the time
- •severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale)
- •current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD)
- •drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
结局指标
主要结局
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
时间窗: Baseline, rehab discharge, month 3, month 6, month 12
Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.
次要结局
未报告次要终点
研究者
Elizabeth R. Skidmore, PhD, OTR/L
Assistant Professor
University of Pittsburgh