RecruitingNot Applicable

Emotional Recovery Post-Stroke

United States80 participantsStarted 2025-05-01

Plain-language summary

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness. * Have experienced ischemic or hemorrhagic stroke at least 30 days prior * Stroke-related aphasia and/or upper extremity hemiparesis * Aged 21 years or older * English as primary language * Have corrected vision to be able to read text on a screen * Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service * Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist Exclusion Criteria: * Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures. * Pain that interferes with ability to participate in the study's upper extremity movement tasks. * Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.

Patient Specific Functional Scale (PSFS)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.

Stroke and Aphasia Quality of Life Scale (SAQoL)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.

Trial details

NCT IDNCT06782321

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Patricia Finetto

843-792-8533 piersonp@musc.edu

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.

Patient Specific Functional Scale (PSFS)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.

Stroke and Aphasia Quality of Life Scale (SAQoL)

Timeframe: Baseline, pre-intervention and immediately after the intervention, Week 8.