NCT07597226尚未招募不适用
Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
研究概览
简要总结
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
- •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
排除标准
- •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.
研究组 & 干预措施
VAST + PASUC
Experimental
干预措施: VAST (Behavioral)
VAST + PASUC
Experimental
干预措施: PASUC alone (Behavioral)
PASUC alone
Active Comparator
干预措施: PASUC alone (Behavioral)
结局指标
主要结局
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
时间窗: Baseline, 6 weeks, 18 weeks
This is scored from ange 0-100, with higher scores indicating better function
次要结局
- 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)(baseline, 6 weeks, 18 weeks)
- Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)(Baseline, 6 weeks, 18 weeks)
- Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment(Baseline, 6 weeks,18 weeks)
- Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)(Baseline, 6 weeks, 18 weeks)
- Change in functional mobility as assessed by the Timed Up and Go (TUG) test(Baseline, 6 weeks, 18 weeks)
研究者
Sean Savitz
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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