NCT05659784已完成不适用
Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility as assessed by number of participants that completed all scheduled visits.
研究概览
简要总结
The purpose of this study is to investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed consent provided by the subject or legally authorized representative.
- •Occurrence of a hemorrhagic or ischemic stroke
- •pre-stroke mRS less than 3
- •Qualifying Stroke Event must be confirmed by CT or MRI
- •Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
- •Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
- •Able to access the internet via a personal device
排除标准
- •. History of neurological or other disease resulting in significant functional impairment (e.g.Parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality).
- •Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
- •Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.
结局指标
主要结局
Feasibility as assessed by number of participants that completed all scheduled visits.
时间窗: end of study(12 weeks form baseline)
次要结局
- Change in Functional independence as assessed by the Functional Independence Measure (FIM)(Baseline, end of study (about 13-14 weeks after baseline))
- Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)(Baseline, end of study (about 13-14 weeks after baseline))
- Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)(Baseline, end of study (about 13-14 weeks after baseline))
- Change in quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)(Baseline, end of study (about 13-14 weeks after baseline))
- Patient-Specific Functional Scale(Baseline, end of study (about 13-14 weeks after baseline))
- Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)(Baseline, end of study (about 13-14 weeks after baseline))
- Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)(Baseline, end of study (about 13-14 weeks after baseline))
- Change in performance in activities of daily living as assessed by the Barthel Index(Baseline, end of study (about 13-14 weeks after baseline))
研究者
Sean Savitz
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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