StrokeVAST TXNCT07597226
Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities
A study testing VAST and PASUC alone in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical effectiveness of Virtually Assisted Home Rehabilitation After Acute STroke (VAST) + post-acute stroke usual care (PASUC) compared to PASUC alone and examine how social determinants of health (SDOH) influence access to and utilization of PASUC rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- VAST and PASUC alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital admission with primary ICD-10 discharge diagnosis of Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH)
- o those being referred from the community settings must be within 60 days of post-acute discharge.
- Post-stroke functional deficits warranting PASUC rehabilitation
- Clinically stable and appropriate for discharge per acute care facility
- Completion of a rehabilitation evaluation within the acute setting
- Planned discharge to home (with or without Home Health (HH)/Outpatient Rehabilitation (OPR), Inpatient Rehabilitation Facility (IRF), or Skilled Nursing Facility (SNF)
Show all 10Show fewer
- Ability to speak and read English or Spanish
- Ability to provide informed consent (patient or LAR)
- o If LAR is consenting, patient must be able to follow simple commands
- Access to a video-capable device and internet
Who cannot join
- Clinically unstable medical condition
- Poorly controlled severe mental illness
- Planned discharge to a long-term care facility (LTACH)
- Inability to complete follow-up (psychiatric hospitalization, hospice, incarceration, homelessness)
- Discharge against medical advice
- Significant language impairment (NIHSS Commands >1 or Best Language >2)- Cognitive impairment (Six-Item, PROMIS) -Severe depression (PHQ-8 >20 or psychiatric hospitalization previous 30 days)- Pre-stroke mRS >3
- Other neurological or musculoskeletal conditions substantially limiting participation o Patients excluded for one of these criteria may be reassessed at 60-days to see if improvement has occurred.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sean Savitz, MD, (713) 500-7083, Sean.I.Savitz@uth.tmc.edu
Emily Stevens, 713-500-7914, emily.a.stevens@uth.tmc.edu
About this study
The purpose of this study is to evaluate the clinical effectiveness of Virtually Assisted Home Rehabilitation After Acute STroke (VAST) + post-acute stroke usual care (PASUC) compared to PASUC alone and examine how social determinants of health (SDOH) influence access to and utilization of PASUC rehabilitation.
- Conditions
- Stroke
- Being tested
- VAST, PASUC alone
- Keywords
- Tele-Rehabilitation, stroke survivors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASTBehavioural
Participants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching
PASUC aloneBehavioural
Participants will receive physical therapy, occupational therapy, speech and language therapy, and medical/nursing care aimed at improving functional mobility, activities of daily living, communication, and overall independence. Rehabilitation is individualized based on patient needs and delivered in a supervised clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| VAST + PASUC | Experimental | Not described Receives: Behavioral: VAST; Behavioral: PASUC alone |
| PASUC alone | Active comparator | Not described Receives: Behavioral: PASUC alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
This is scored from ange 0-100, with higher scores indicating better function
Measured: Baseline, 6 weeks, 18 weeks
Secondary outcomes (5)
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)SIS domains (strength, mobility, hand function, communication, emotion, memory/thinking, and participation roles)
This is a A 59 item questionnaire whereby subjects identify the impact of stroke on strength, mobility, hand function, communication, emotion, memory/thinking, and participation roles. 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
Measured: baseline, 6 weeks, 18 weeks
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
mRS is a 6 point disability scale with possible scores from 0(no disability) to 5(disability requiring constant care) a higher score indicating more disability
Measured: Baseline, 6 weeks, 18 weeks
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome
Measured: Baseline, 6 weeks,18 weeks
Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)
Participants will be instructed to rise from a seated position to standing and return to sitting five consecutive times as quickly as possible without using their upper extremities, if able. Shorter completion times indicate better functional performance and lower extremity strength.
Measured: Baseline, 6 weeks, 18 weeks
Change in functional mobility as assessed by the Timed Up and Go (TUG) test
Participants will be instructed to stand up from a standard chair, walk 3 meters, turn around, walk back to the chair, and sit down. Shorter completion times indicate better functional mobility and dynamic balance.
Measured: Baseline, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lone Star Stroke Consortium
- Responsible party
- Principal investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean Savitz, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597226
- Sponsor's protocol ID
- HSC-MS-26-0119
- Acronym
- VAST TX
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities
- ClinicalTrials.gov ID
- NCT07597226
- Acronym / sponsor ID
- VAST TX / HSC-MS-26-0119
- Conditions
- Stroke
- Keywords
- Tele-Rehabilitation, stroke survivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Lone Star Stroke Consortium
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical effectiveness of Virtually Assisted Home Rehabilitation After Acute STroke (VAST) + post-acute stroke usual care (PASUC) compared to PASUC alone and examine how social determinants of health (SDOH) influence access to and utilization of PASUC rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAST + PASUC | Experimental | Behavioral: VAST, Behavioral: PASUC alone |
| PASUC alone | Active comparator | Behavioral: PASUC alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hospital admission with primary ICD-10 discharge diagnosis of Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH)
- o those being referred from the community settings must be within 60 days of post-acute discharge.
- Post-stroke functional deficits warranting PASUC rehabilitation
- Clinically stable and appropriate for discharge per acute care facility
- Completion of a rehabilitation evaluation within the acute setting
Key exclusion criteria (7 listed)
- Clinically unstable medical condition
- Poorly controlled severe mental illness
- Planned discharge to a long-term care facility (LTACH)
- Inability to complete follow-up (psychiatric hospitalization, hospice, incarceration, homelessness)
- Discharge against medical advice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VASTParticipants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching | Behavioural | VAST + PASUC |
| PASUC aloneParticipants will receive physical therapy, occupational therapy, speech and language therapy, and medical/nursing care aimed at improving functional mobility, activities of daily living, communication, and overall independence. Rehabilitation is individualized based on patient needs and delivered in a supervised clinical setting. | Behavioural | PASUC alone, VAST + PASUC |
Primary outcome
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
Time frame: Baseline, 6 weeks, 18 weeks
This is scored from ange 0-100, with higher scores indicating better function
5 secondary outcomes
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)SIS domains (strength, mobility, hand function, communication, emotion, memory/thinking, and participation roles)
Time frame: baseline, 6 weeks, 18 weeks
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
Time frame: Baseline, 6 weeks, 18 weeks
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Time frame: Baseline, 6 weeks,18 weeks
Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)
Time frame: Baseline, 6 weeks, 18 weeks
Change in functional mobility as assessed by the Timed Up and Go (TUG) test
Time frame: Baseline, 6 weeks, 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Savitz, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAST and PASUC alone in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Savitz, MD ((713) 500-7083, Sean.I.Savitz@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale (time frame: Baseline, 6 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.