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Completed

NCT Number: NCT05659784

Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)

The purpose of this study is to investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.

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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.
  • Occurrence of a hemorrhagic or ischemic stroke
  • pre-stroke mRS 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 via a personal device

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

Other

Education based telerehab with rehabilitation therapists providing education on home exercises and stroke specific information

Primary outcomes

  1. Feasibility as assessed by number of participants that completed all scheduled visits.

    Time frame: end of study(12 weeks form baseline)

Secondary outcomes

  1. Change in Functional independence as assessed by the Functional Independence Measure (FIM)

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    This is an 18 item questionnaire and each is scored from 1(complete dependence on helper) to 7(complete independence), a higher number indicating more independence

  2. Patient-Specific Functional Scale

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    This tool allows for Subjects to self report activities of daily living that have been affected by stroke and rate severity of impact on these activities. This is scored from 0(unable to perform activity) to 10(able to perform activity at the same level as before injury or problem)

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

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    This is a A 59 item questionnaire whereby subjects identify the impact of stroke 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

  4. Change in quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    A self reporting, quality of life measurement that asks Subjects to rate their severity of problems related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 5 questions in the first section and each question is scored from 0-5,a higher number indicating a worse outcome .There is a visual scale at the end that is scored from 0(worst health) to 100(best health), higher number indicating better outcome .

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  5. Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    8 item questionnaire ,with a possible score of 1-5, a lower number indicating higher cognitive impairment

  6. Change in performance in activities of daily living as assessed by the Barthel Index

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    This is a scoring technique that measures performance in ten activities of daily living including feeding, wheelchair to bed transfers, grooming ,chair to toilet transfers, walking, using stairs, dressing, and continence of bowels and bladder. This is a 10 item questionnaire and is scored from 0-100, a higher score indicating higher level of independence.

  7. Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    the score for each ability is a number between 0(normal functioning) to 4(completely impaired). The score is calculated by adding the number for each element of the scale with a highest score of 42, a higher score meaning more impairment.

  8. Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)

    Time frame: Baseline, end of study (about 13-14 weeks after baseline)

    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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: VAST-rehab

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
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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