Stroke
Conditions
Keywords
Tele-Rehabilitation, stroke survivors
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.
Interventions
BEHAVIORALVAST
Participants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching
BEHAVIORALPASUC 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.
Sponsors
The University of Texas Health Science Center, Houston
Lone Star Stroke Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived ability to perform activities of daily living and functional mobility as assessed by the Stroke Impact Scale (SIS)-Activity subscale | Baseline, 6 weeks, 18 weeks | This is scored from ange 0-100, with higher scores indicating better function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS) | 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 |
| Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment | 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 |
| Change in lower extremity functional strength as assessed by the Five Times Sit-to-Stand Test (5xSTS) | 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. |
| Change in functional mobility as assessed by the Timed Up and Go (TUG) test | 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. |
Countries
United States
Contacts
CONTACTSean Savitz, MD
CONTACTTolulope Fashina
PRINCIPAL_INVESTIGATORSean Savitz, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed