Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities (VAST TX)
12. mai 2026 oppdatert av: Sean Savitz, The University of Texas Health Science Center, Houston
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sean Savitz, MD
- Telefonnummer: (713) 500-7083
- E-post: Sean.I.Savitz@uth.tmc.edu
Studer Kontakt Backup
- Navn: Tolulope Fashina
- Telefonnummer: 713-500-7914
- E-post: tolulope.fashina@uth.tmc.edu
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
-
Ta kontakt med:
- Sean Savitz, MD
- Telefonnummer: (713) 500-7083
- E-post: Sean.I.Savitz@uth.tmc.edu
-
Ta kontakt med:
- Emily Stevens
- Telefonnummer: 713-500-7914
- E-post: emily.a.stevens@uth.tmc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: VAST + PASUC
|
Participants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching
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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
Tidsramme: Baseline, 6 weeks, 18 weeks
|
This is scored from ange 0-100, with higher scores indicating better function
|
Baseline, 6 weeks, 18 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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
|
baseline, 6 weeks, 18 weeks
|
|
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
Tidsramme: 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
|
Baseline, 6 weeks, 18 weeks
|
|
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Tidsramme: 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
|
Baseline, 6 weeks,18 weeks
|
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Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS)
Tidsramme: 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.
|
Baseline, 6 weeks, 18 weeks
|
|
Change in functional mobility as assessed by the Timed Up and Go (TUG) test
Tidsramme: 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.
|
Baseline, 6 weeks, 18 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sean Savitz, MD, The University of Texas Health Science Center, Houston
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juni 2026
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
31. januar 2027
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
12. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-MS-26-0119
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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