Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities (VAST TX)
12 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sean Savitz, MD
- Telefonnummer: (713) 500-7083
- E-post: Sean.I.Savitz@uth.tmc.edu
Studera Kontakt Backup
- Namn: Tolulope Fashina
- Telefonnummer: 713-500-7914
- E-post: tolulope.fashina@uth.tmc.edu
Studieorter
-
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Texas
-
Houston, Texas, Förenta staterna, 77030
- The University of Texas Health Science Center at Houston
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Kontakt:
- Sean Savitz, MD
- Telefonnummer: (713) 500-7083
- E-post: Sean.I.Savitz@uth.tmc.edu
-
Kontakt:
- Emily Stevens
- Telefonnummer: 713-500-7914
- E-post: emily.a.stevens@uth.tmc.edu
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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Aktiv komparator: PASUC alone
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale
Tidsram: Baseline, 6 weeks, 18 weeks
|
This is scored from ange 0-100, with higher scores indicating better function
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Baseline, 6 weeks, 18 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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)
Tidsram: 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
|
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Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
Tidsram: 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
|
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Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Tidsram: 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
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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)
Tidsram: 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.
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Baseline, 6 weeks, 18 weeks
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Change in functional mobility as assessed by the Timed Up and Go (TUG) test
Tidsram: 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.
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Baseline, 6 weeks, 18 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Sean Savitz, MD, The University of Texas Health Science Center, Houston
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 juni 2026
Primärt slutförande (Beräknad)
31 oktober 2026
Avslutad studie (Beräknad)
31 januari 2027
Studieregistreringsdatum
Först inskickad
12 maj 2026
Först inskickad som uppfyllde QC-kriterierna
12 maj 2026
Första postat (Faktisk)
19 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSC-MS-26-0119
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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