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

The University of Texas Health Science Center, Houston1 site in 1 country15 target enrollmentMarch 9, 2023

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 15
Locations: 1
Primary Endpoint: The experience of the participant measured by the participant experience surveys
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 9, 2023

End Date

January 26, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Sean Savitz

Professor

The University of Texas Health Science Center, Houston

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.

Outcomes

Primary Outcomes

The experience of the participant measured by the participant experience surveys

Time Frame: end of study (about 10 weeks after baseline)

Number of participants that completed all scheduled visits.

Time Frame: end of study (about 10 weeks after baseline)

Secondary Outcomes

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)