Clinical trial NCT06782321: Emotional Recovery Post-Stroke
Official title: Centering Emotional Recovery Post-Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Mental Health Wellness 1
Keywords: Rehabilitation Studies
Stroke
Stroke Recovery
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
First posted: 2025-01-17
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized rehabilitation clinical trial with adaptive design. At study midpoint, a preliminary analysis will identify the intervention showing the greatest effect on the majority of the primary outcome measures. Subsequently, the randomization ratio will be adapted to 2:1 in favor of that intervention
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.

Eligibility criteria: 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.

Primary outcomes:
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
timeFrame: Baseline, pre-intervention and immediately after the intervention, Week 8.
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Baseline, pre-intervention and immediately after the intervention, Week 8.
measure: Stroke and Aphasia Quality of Life Scale (SAQoL)
timeFrame: Baseline, pre-intervention and immediately after the intervention, Week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michelle Woodbury, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Lisa McTeague, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Central Florida
name: Deena Blackett, PhD
role: PRINCIPAL_INVESTIGATOR
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