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NCT Number: NCT07597226

Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

VAST

Behavioral

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 alone

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)

    Time frame: Baseline, 6 weeks, 18 weeks

    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

  3. Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment

    Time frame: Baseline, 6 weeks,18 weeks

    This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome

  4. Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)

    Time frame: Baseline, 6 weeks, 18 weeks

    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.

  5. Change in functional mobility as assessed by the Timed Up and Go (TUG) test

    Time frame: Baseline, 6 weeks, 18 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Savitz, MD

CONTACT

[email protected]

(713) 500-7083

Tolulope Fashina

CONTACT

[email protected]

713-500-7914

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Lone Star Stroke Consortium

Registry information

Acronym: VAST TX

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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