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

February 22, 2024 updated by: Sean Savitz, The University of Texas Health Science Center, Houston

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telerehabilitation (VAST 2)
Other: Telerehabilitation (VAST 2)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The experience of the participant measured by the participant experience surveys
Time Frame: end of study (about 10 weeks after baseline)
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)
end of study (about 10 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
Time Frame: Baseline, end of intervention (about 5 weeks after baseline)
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
Time Frame: Baseline, end of intervention (about 5 weeks after baseline)
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)
Time Frame: Baseline, end of intervention (about 5 weeks after baseline)
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)
Time Frame: Baseline, end of intervention (about 5 weeks after baseline)
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)
Time Frame: Baseline, end of intervention (about 5 weeks after baseline)
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).
Time Frame: week 2
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).
Time Frame: week 3
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).
Time Frame: week 4
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).
Time Frame: week 5
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).
Time Frame: week 10
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
end of intervention (about 5 weeks after baseline)
Type of technology used by caregivers as assessed by a questionnaire
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
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
Time Frame: end of intervention (about 5 weeks after baseline)
end of intervention (about 5 weeks after baseline)
Number of patients living in underserved areas
Time Frame: Baseline
Baseline
Number of patients living in under resourced neighborhoods
Time Frame: Baseline
Baseline
Socio Economic Status (SES) of patients as assessed by the patient demographics
Time Frame: Baseline
Baseline
Housing condition of patients as assessed by the patient demographics
Time Frame: Baseline
Baseline
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 2
week 2
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 3
week 3
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 4
week 4
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 5
week 5
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 2
week 2
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 3
week 3
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 4
week 4
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame: week 5
week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lone Star Stroke Consortium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Savitz, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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