NCT05737524已完成不适用
Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The experience of the participant measured by the participant experience surveys
研究概览
简要总结
The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health
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.
- •Diagnosed with hemorrhagic or ischemic stroke
- •Pre-stroke mRS is 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
- •Mild-moderate impairments in motor or cognitive function
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
The experience of the participant measured by the participant experience surveys
时间窗: end of study (about 10 weeks after baseline)
Number of participants that completed all scheduled visits.
时间窗: end of study (about 10 weeks after baseline)
次要结局
- Socio Economic Status (SES) of patients as assessed by the patient demographics(Baseline)
- Housing condition of patients as assessed by the patient demographics(Baseline)
- Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.(week 5)
- Change in quality of life as assessed by the Short Form (SF-12)health questionnaire(Baseline, end of intervention (about 5 weeks after baseline))
- Number of stroke patients who exhibited any issues when they use the telehealth platform(end of intervention (about 5 weeks after baseline))
- Use of computer equipment by caregivers as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Use of computer equipment by stroke patients as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)(Baseline, end of intervention (about 5 weeks after baseline))
- Change in disability as assessed by the Modified Rankin Scale (mRS)(Baseline, end of intervention (about 5 weeks after baseline))
- Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).(week 10)
- Number of patients living in underserved areas(Baseline)
- Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.(week 5)
- Type of technology used by stroke patients as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Type of internet access used by stroke patients as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Type of technology used by caregivers as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)(Baseline, end of intervention (about 5 weeks after baseline))
- Change in depression as assessed by the Patient Health Questionnaire (PHQ8)(Baseline, end of intervention (about 5 weeks after baseline))
- Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Type of internet access used by caregivers as assessed by a questionnaire(end of intervention (about 5 weeks after baseline))
- Number of caregivers who exhibited any issues when they use the telehealth platform(end of intervention (about 5 weeks after baseline))
- Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events(end of intervention (about 5 weeks after baseline))
- Number of patients living in under resourced neighborhoods(Baseline)
研究者
Sean Savitz
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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