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Completed

NCT Number: NCT05737524

Virtually Assisted Home Rehabilitation After Acute Stroke-2

The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent provided by the subject or legally authorized representative.
  • Diagnosed with hemorrhagic or ischemic stroke
  • Pre-stroke mRS is less than 3
  • Qualifying Stroke Event must be confirmed by CT or MRI
  • Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
  • Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
  • Able to access the internet
  • Mild-moderate impairments in motor or cognitive function

Exclusion criteria

  • History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality).
  • Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
  • Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.

Treatment and study plan

Telerehabilitation (VAST 2)

Other

The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.

Primary outcomes

  1. The experience of the participant measured by the participant experience surveys

    Time frame: end of study (about 10 weeks after baseline)

  2. Number of participants that completed all scheduled visits.

    Time frame: end of study (about 10 weeks after baseline)

Secondary outcomes

  1. Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)

    Time frame: Baseline, end of intervention (about 5 weeks after baseline)

    This is a A 59 item questionnaire whereby subjects identify the impact of treatment on strength, hand function, mobility, activities of daily living, memory, communication, emotion, and handicap. 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

  2. Change in quality of life as assessed by the Short Form (SF-12)health questionnaire

    Time frame: Baseline, end of intervention (about 5 weeks after baseline)

    This is a health related quality of life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

  3. Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, end of intervention (about 5 weeks after baseline)

    Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

  4. Change in depression as assessed by the Patient Health Questionnaire (PHQ8)

    Time frame: Baseline, end of intervention (about 5 weeks after baseline)

    This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression

  5. Change in disability as assessed by the Modified Rankin Scale (mRS)

    Time frame: Baseline, end of intervention (about 5 weeks after baseline)

    This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome

  6. Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).

    Time frame: week 2

    This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment

  7. Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).

    Time frame: week 3

    This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment

  8. Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).

    Time frame: week 4

    This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment

  9. Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).

    Time frame: week 5

    This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment

  10. Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).

    Time frame: week 10

    This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment

  11. Type of technology used by stroke patients as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.

  12. Type of internet access used by stroke patients as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband

  13. Use of computer equipment by stroke patients as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones

  14. Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped

  15. Number of stroke patients who exhibited any issues when they use the telehealth platform

    Time frame: end of intervention (about 5 weeks after baseline)

  16. Type of technology used by caregivers as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.

  17. Type of internet access used by caregivers as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband

  18. Use of computer equipment by caregivers as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones

  19. Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire

    Time frame: end of intervention (about 5 weeks after baseline)

    Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped

  20. Number of caregivers who exhibited any issues when they use the telehealth platform

    Time frame: end of intervention (about 5 weeks after baseline)

  21. Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events

    Time frame: end of intervention (about 5 weeks after baseline)

  22. Number of patients living in underserved areas

    Time frame: Baseline

  23. Number of patients living in under resourced neighborhoods

    Time frame: Baseline

  24. Socio Economic Status (SES) of patients as assessed by the patient demographics

    Time frame: Baseline

  25. Housing condition of patients as assessed by the patient demographics

    Time frame: Baseline

  26. Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 2

  27. Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 3

  28. Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 4

  29. Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 5

  30. Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 2

  31. Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 3

  32. Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 4

  33. Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.

    Time frame: week 5

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Lone Star Stroke Consortium

Registry information

Official study title

Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)

Acronym: (VAST-rehab2)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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