Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities (VAST TX)
2026年5月12日 更新者：Sean Savitz、The University of Texas Health Science Center, Houston
The purpose of this study is to evaluate the clinical effectiveness of Virtually Assisted Home Rehabilitation After Acute STroke (VAST) + post-acute stroke usual care (PASUC) compared to PASUC alone and examine how social determinants of health (SDOH) influence access to and utilization of PASUC rehabilitation.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sean Savitz, MD
- 电话号码：(713) 500-7083
- 邮箱：Sean.I.Savitz@uth.tmc.edu
研究联系人备份
- 姓名：Tolulope Fashina
- 电话号码：713-500-7914
- 邮箱：tolulope.fashina@uth.tmc.edu
学习地点
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Texas
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Houston、Texas、美国、77030
- The University of Texas Health Science Center at Houston
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接触：
- Sean Savitz, MD
- 电话号码：(713) 500-7083
- 邮箱：Sean.I.Savitz@uth.tmc.edu
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接触：
- Emily Stevens
- 电话号码：713-500-7914
- 邮箱：emily.a.stevens@uth.tmc.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Hospital admission with primary ICD-10 discharge diagnosis of Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH)
o those being referred from the community settings must be within 60 days of post-acute discharge.
- Post-stroke functional deficits warranting PASUC rehabilitation
- Clinically stable and appropriate for discharge per acute care facility
- Completion of a rehabilitation evaluation within the acute setting
- Planned discharge to home (with or without Home Health (HH)/Outpatient Rehabilitation (OPR), Inpatient Rehabilitation Facility (IRF), or Skilled Nursing Facility (SNF)
- Ability to speak and read English or Spanish
Ability to provide informed consent (patient or LAR)
o If LAR is consenting, patient must be able to follow simple commands
- Access to a video-capable device and internet
Exclusion Criteria:
- Clinically unstable medical condition
- Poorly controlled severe mental illness
- Planned discharge to a long-term care facility (LTACH)
- Inability to complete follow-up (psychiatric hospitalization, hospice, incarceration, homelessness)
- Discharge against medical advice
- Significant language impairment (NIHSS Commands >1 or Best Language >2)- Cognitive impairment (Six-Item, PROMIS) -Severe depression (PHQ-8 >20 or psychiatric hospitalization previous 30 days)- Pre-stroke mRS >3
- Other neurological or musculoskeletal conditions substantially limiting participation o Patients excluded for one of these criteria may be reassessed at 60-days to see if improvement has occurred.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：VAST + PASUC
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Participants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching
Participants will receive physical therapy, occupational therapy, speech and language therapy, and medical/nursing care aimed at improving functional mobility, activities of daily living, communication, and overall independence.
Rehabilitation is individualized based on patient needs and delivered in a supervised clinical setting.
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有源比较器：PASUC alone
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Participants will receive physical therapy, occupational therapy, speech and language therapy, and medical/nursing care aimed at improving functional mobility, activities of daily living, communication, and overall independence.
Rehabilitation is individualized based on patient needs and delivered in a supervised clinical setting.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
大体时间：Baseline, 6 weeks, 18 weeks
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This is scored from ange 0-100, with higher scores indicating better function
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Baseline, 6 weeks, 18 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)SIS domains (strength, mobility, hand function, communication, emotion, memory/thinking, and participation roles)
大体时间：baseline, 6 weeks, 18 weeks
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This is a A 59 item questionnaire whereby subjects identify the impact of stroke on strength, mobility, hand function, communication, emotion, memory/thinking, and participation roles.
Item responses are scored on a 5-point Likert-style scale.
A score of 1 = an inability to complete the item and a score of 5 = no difficulty experienced at all.
A standardized score ranging from 0 to 100 is calculated for all domains, with higher scores indicating a higher quality of life
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baseline, 6 weeks, 18 weeks
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Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
大体时间：Baseline, 6 weeks, 18 weeks
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mRS is a 6 point disability scale with possible scores from 0(no disability) to 5(disability requiring constant care) a higher score indicating more disability
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Baseline, 6 weeks, 18 weeks
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Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
大体时间：Baseline, 6 weeks,18 weeks
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This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome
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Baseline, 6 weeks,18 weeks
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Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)
大体时间：Baseline, 6 weeks, 18 weeks
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Participants will be instructed to rise from a seated position to standing and return to sitting five consecutive times as quickly as possible without using their upper extremities, if able.
Shorter completion times indicate better functional performance and lower extremity strength.
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Baseline, 6 weeks, 18 weeks
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Change in functional mobility as assessed by the Timed Up and Go (TUG) test
大体时间：Baseline, 6 weeks, 18 weeks
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Participants will be instructed to stand up from a standard chair, walk 3 meters, turn around, walk back to the chair, and sit down.
Shorter completion times indicate better functional mobility and dynamic balance.
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Baseline, 6 weeks, 18 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sean Savitz, MD、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2027年1月31日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年5月19日
上次提交的符合 QC 标准的更新
2026年5月12日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.