Virtually Assisted Home Rehabilitation After Acute Stroke-2

Study Overview
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Brief Summary
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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

Official Title
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Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)

Conditions
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Stroke

Intervention / Treatment
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* Other: Telerehabilitation (VAST 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation (VAST 2)<br> | Other: Telerehabilitation (VAST 2)<br>* The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The experience of the participant measured by the participant experience surveys |  | end of study (about 10 weeks after baseline) | 
| Number of participants that completed all scheduled visits. |  | end of study (about 10 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in impact of stroke as assessed by the Stroke Impact Scale (SIS) | This is a A 59 item questionnaire whereby subjects identify the impact of treatment on strength, hand function, mobility, activities of daily living, memory, communication, emotion, and handicap. 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 | Baseline, end of intervention (about 5 weeks after baseline) | 
| Change in quality of life as assessed by the Short Form (SF-12)health questionnaire | This is a health related quality of life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Baseline, end of intervention (about 5 weeks after baseline) | 
| Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA) | Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome. | Baseline, end of intervention (about 5 weeks after baseline) | 
| Change in depression as assessed by the Patient Health Questionnaire (PHQ8) | This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression | Baseline, end of intervention (about 5 weeks after baseline) | 
| Change in disability as assessed by the Modified Rankin Scale (mRS) | This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome | 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). | This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment | week 2 | 
| Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS). | This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment | week 3 | 
| Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS). | This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment | week 4 | 
| Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS). | This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment | week 5 | 
| Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS). | This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment | week 10 | 
| Type of technology used by stroke patients as assessed by a questionnaire | Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop. | end of intervention (about 5 weeks after baseline) | 
| Type of internet access used by stroke patients as assessed by a questionnaire | Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband | end of intervention (about 5 weeks after baseline) | 
| Use of computer equipment by stroke patients as assessed by a questionnaire | Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones | 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 | Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped | 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) | 
| Type of technology used by caregivers as assessed by a questionnaire | Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop. | end of intervention (about 5 weeks after baseline) | 
| Type of internet access used by caregivers as assessed by a questionnaire | Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband | end of intervention (about 5 weeks after baseline) | 
| Use of computer equipment by caregivers as assessed by a questionnaire | Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones | end of intervention (about 5 weeks after baseline) | 
| Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire | Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped | 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 underserved areas |  | Baseline | 
| Number of patients living in under resourced neighborhoods |  | Baseline | 
| Socio Economic Status (SES) of patients as assessed by the patient demographics |  | Baseline | 
| Housing condition of patients as assessed by the patient demographics |  | Baseline | 
| Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 2 | 
| Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 3 | 
| Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 4 | 
| Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 5 | 
| Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 2 | 
| Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 3 | 
| Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 4 | 
| Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform. |  | week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telerehabilitation