Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 16
- 主要终点
- Stroke Impact Scale (SIS) Hand Function Subscale Score.
研究概览
简要总结
This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.
详细描述
Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.
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)
盲法说明
Blinded to treatment allocation
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ASAP
A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence.
干预措施: Accelerated Skill Acquisition Program (ASAP) (Behavioral)
DEUCC
Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
干预措施: Dose-Equivalent Usual & Customary Care - DEUCC (Behavioral)
UCC
Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices.
干预措施: Usual and Customary Care - UCC (Behavioral)
结局指标
主要结局
Stroke Impact Scale (SIS) Hand Function Subscale Score.
时间窗: Baseline to 1 year post-randomization
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.
Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)
时间窗: Baseline to 1 year post-randomization
The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.
Wolf Motor Function Test (WMFT) Log-transformed Time
时间窗: Baseline to 1 year post-randomization
Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.
Wolf Motor Function Test Time
时间窗: Baseline to 1 year post-randomization
Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.
次要结局
- D-KEFS Verbal Fluency Test(Baseline to 1 year post-randomization)
- As-Tex Sensory Index(Baseline to 1 year post-randomization)
- Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)(Baseline to 1 year post-randomization)
- National Institute of Health Stroke Scale (NIHSS)(Baseline to 1 year post-randomization)
- Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Shoulder Flexors(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Elbow Flexors(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Shoulder Extensors(Baseline to 1 year post-randomization)
- Stroke Impact Scale (SIS) ADL/IADL Subscale Score.(Baseline to 1 year post-randomization)
- Stroke Impact Scale (SIS) Mobility Subscale Score.(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Wrist Flexors(Baseline to 1 year post-randomization)
- Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Wrist Extensors(Baseline to 1 year post-randomization)
- Upper Extremity Fugl Meyer (UEFM), Motor Component(Baseline to 1 year post-randomization)
- Arm Muscle Torque Test - Elbow Extensors(Baseline to 1 year post-randomization)
- Digits Span Backward(Baseline to 1 year post-randomization)
- Hopkins Verbal Learning Test, Revised (HVLT-R)(Baseline to 1 year post-randomization)
- Color Trails Making Tests 1 & 2(Baseline to 1 year post-randomization)
- Short Blessed Memory Test(Baseline to 1 year post-randomization)
- Confidence in Arm & Hand Movement (CAHM)(Baseline to 1 year post-randomization)
- Motor Activity Log 28 QOM (MAL-28)(Baseline to 1 year post-randomization)
- Satisfaction With Life Scale (SWLS)(Baseline to 1 year post-randomization)
- Stroke Impact Scale (SIS) Communication Subscale Score.(Baseline to 1 year post-randomization)
- Single-Item Subjective Quality of Life Measurement (SQOL)(Baseline to 1 year post-randomization)
- Reintegration to Normal Living Index (RNLI)(Baseline to 1 year post-randomization)
- Stroke Impact Scale (SIS) Emotion Subscale Score.(Baseline to 1 year post-randomization)
- EQ5D(Baseline to 1 year post-randomization)
- Patient Health Questionnaire 9 (PHQ-9)(Baseline to 1 year post-randomization)
研究者
Carolee Winstein
Professor
University of Southern California