About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospital admission with primary ICD-10 discharge diagnosis of Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH)
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
VAST
BehavioralParticipants will receive a planned 4-week, home-based telerehabilitation (TR) intervention that integrates discipline-specific rehabilitation therapy with embedded self management health coaching
PASUC alone
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
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.
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
Lone Star Stroke Consortium
Collaborator
This trial is not recruiting at the moment. You can still explore other options: