Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities

NCT07597226 | Not Yet Recruiting

• 1 other identifier: HSC-MS-26-0119
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Tele-Rehabilitation; stroke survivors

Outcome Measures

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

  This is scored from ange 0-100, with higher scores indicating better function

  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)

  baseline, 6 weeks, 18 weeks

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

  Baseline, 6 weeks, 18 weeks

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

  Baseline, 6 weeks,18 weeks

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

  Baseline, 6 weeks, 18 weeks

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

  Baseline, 6 weeks, 18 weeks

Study Arms (2)

VAST + PASUC

EXPERIMENTAL

Behavioral: VAST; Behavioral: PASUC alone

PASUC alone

ACTIVE COMPARATOR

Behavioral: PASUC alone

Interventions

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

VAST + PASUC

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.

PASUC alone; VAST + PASUC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Lone Star Stroke Consortium: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Sean Savitz, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Savitz, MD

CONTACT

(713) 500-7083; Sean.I.Savitz@uth.tmc.edu

Tolulope Fashina

CONTACT

713-500-7914; tolulope.fashina@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)