Virtually Assisted Home Rehabilitation After Stroke for Underserved Texas Communities

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: VAST + PASUCExperimental treatment 2 interventions
Group B: PASUC aloneActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline, 6 weeks, 18 weeks

Secondary outcomes

1

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

Time frame
baseline, 6 weeks, 18 weeks
2

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

Time frame
Baseline, 6 weeks, 18 weeks
3

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

Time frame
Baseline, 6 weeks,18 weeks
4

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.

Time frame
Baseline, 6 weeks, 18 weeks

Other outcomes

Sponsors and contacts

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