What side effects are associated with this type of intervention?

Telerehabilitation for stroke, which involves remote delivery of rehabilitation services using digital platforms, is generally well-tolerated. However, some patients may experience mild side effects such as fatigue, muscle soreness, or discomfort from prolonged use of digital devices. Additionally, there may be challenges related to technology use, including difficulties with internet connectivity or device operation, which can impact the effectiveness of the therapy. Broadly, traditional stroke treatments like physical therapy, occupational therapy, and speech therapy are associated with minimal side effects, primarily limited to physical exertion and occasional discomfort during exercises.

What prior FDA approvals exist?

The FDA has approved various treatments for stroke, primarily focusing on acute management and secondary prevention. These include thrombolytic agents like alteplase (tPA) for acute ischemic stroke and anticoagulants such as warfarin and direct oral anticoagulants for secondary prevention. While specific FDA approvals for telerehabilitation in stroke are not detailed, the use of digital platforms for remote rehabilitation is an emerging area of interest, aiming to enhance recovery through accessible, home-based therapy.

What other types of research exist?

Promising, novel alternatives to virtual rehabilitation programs for stroke patients in 2024 include robotic-assisted therapy, advanced wearable technology, and immersive virtual reality (VR) systems. These approaches utilize cutting-edge technology to provide effective and engaging rehabilitation experiences.

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Virtual Rehab for Stroke ((VAST-rehab2) Trial)

N/A

Waitlist Available

Led By Sean Savitz, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hemorrhagic or ischemic stroke

Pre-stroke mRS is less than 3

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a virtual rehabilitation program for stroke patients. The program allows patients to do recovery exercises at home using an online platform. The study aims to see if this method helps patients achieve their recovery goals and understand any challenges they face with this type of rehab. Virtual reality (VR) has gained attention through its ability to deliver customized training sessions and increase patient engagement in stroke rehabilitation.

Who is the study for?

This trial is for individuals who've had a stroke confirmed by CT or MRI, with mild to moderate motor or cognitive impairments. They should be able to follow verbal commands and use the internet, have been recommended for self-guided or in-person rehab, and not have severe other illnesses that could limit survival.

What is being tested?

The study is testing a virtual rehabilitation program (VAST 2) for stroke patients. It aims to see if this home-based telerehabilitation is feasible and effective in improving patient's abilities, reducing hospital readmissions, and overcoming barriers related to social determinants of health.

What are the potential side effects?

Since this trial involves non-invasive telerehabilitation exercises guided virtually, side effects are minimal but may include discomfort from physical activity or frustration with technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a stroke.

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I was mostly independent before my stroke.

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I can understand and follow verbal instructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like Parkinson's or severe arthritis that significantly limits my daily activities.

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I do not have a severe illness that could shorten my life to under 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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

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

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telerehabilitation (VAST 2)Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Virtual rehabilitation programs for stroke patients leverage digital platforms to deliver physical and occupational therapy remotely. These treatments focus on improving motor function, coordination, and daily living skills through guided exercises and activities. The mechanisms of action include neuroplasticity, where repetitive, task-specific training helps the brain reorganize and form new neural connections, and muscle strengthening, which enhances physical capabilities. This approach is crucial for stroke patients as it provides continuous, accessible rehabilitation, promoting recovery and independence while reducing the need for frequent hospital visits.