Clinical trial NCT05737524: Virtually Assisted Home Rehabilitation After Acute Stroke-2
Official title: Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: telerehabilitation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Lone Star Stroke Consortium
First posted: 2023-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: The experience of the participant measured by the participant experience surveys
timeFrame: end of study (about 10 weeks after baseline)
measure: Number of participants that completed all scheduled visits.
timeFrame: end of study (about 10 weeks after baseline)
Secondary outcomes:
measure: Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
timeFrame: Baseline, end of intervention (about 5 weeks after baseline)
measure: Change in quality of life as assessed by the Short Form (SF-12)health questionnaire
timeFrame: Baseline, end of intervention (about 5 weeks after baseline)
measure: Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, end of intervention (about 5 weeks after baseline)
measure: Change in depression as assessed by the Patient Health Questionnaire (PHQ8)
timeFrame: Baseline, end of intervention (about 5 weeks after baseline)
measure: Change in disability as assessed by the Modified Rankin Scale (mRS)
timeFrame: Baseline, end of intervention (about 5 weeks after baseline)
measure: Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
timeFrame: week 2
measure: Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
timeFrame: week 3
measure: Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
timeFrame: week 4
measure: Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
timeFrame: week 5
measure: Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
timeFrame: week 10
measure: Type of technology used by stroke patients as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Type of internet access used by stroke patients as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Use of computer equipment by stroke patients as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Number of stroke patients who exhibited any issues when they use the telehealth platform
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Type of technology used by caregivers as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Type of internet access used by caregivers as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Use of computer equipment by caregivers as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Number of caregivers who exhibited any issues when they use the telehealth platform
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events
timeFrame: end of intervention (about 5 weeks after baseline)
measure: Number of patients living in underserved areas
timeFrame: Baseline
measure: Number of patients living in under resourced neighborhoods
timeFrame: Baseline
measure: Socio Economic Status (SES) of patients as assessed by the patient demographics
timeFrame: Baseline
measure: Housing condition of patients as assessed by the patient demographics
timeFrame: Baseline
measure: Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 2
measure: Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 3
measure: Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 4
measure: Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 5
measure: Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 2
measure: Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 3
measure: Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 4
measure: Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
timeFrame: week 5
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sean Savitz, MD
role: PRINCIPAL_INVESTIGATOR
References: