Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities (VAST TX)

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 Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: VAST; Behavioral: PASUC alone

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean Savitz, MD; Phone Number: (713) 500-7083; Email: Sean.I.Savitz@uth.tmc.edu
• Study Contact Backup: Name: Tolulope Fashina; Phone Number: 713-500-7914; Email: tolulope.fashina@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Sean Savitz, MD; Phone Number: (713) 500-7083; Email: Sean.I.Savitz@uth.tmc.edu
      • Contact: Emily Stevens; Phone Number: 713-500-7914; Email: emily.a.stevens@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAST + PASUC	Behavioral: VAST; Participants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching; Behavioral: PASUC alone; 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.
Active Comparator: PASUC alone	Behavioral: PASUC alone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 6 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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.	Baseline, 6 weeks, 18 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Lone Star Stroke Consortium
• Investigators: Principal Investigator: Sean Savitz, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke survivors; Tele-Rehabilitation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HSC-MS-26-0119

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