Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)

The University of Texas Health Science Center, Houston1 site in 1 country20 target enrollmentApril 20, 2020

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 20
Locations: 1
Primary Endpoint: Feasibility as assessed by number of participants that completed all scheduled visits.
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 investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.

Registry

clinicaltrials.gov

Start Date

April 20, 2020

End Date

May 8, 2023

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.
•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

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

Feasibility as assessed by number of participants that completed all scheduled visits.

Time Frame: end of study(12 weeks form baseline)

Secondary Outcomes

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))