NCT06758505 Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
| NCT ID | NCT06758505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-09-29 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ACES), to help people resume social participation after stroke and live in the community. Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ACES report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to the existing rehabilitation program using strategy training alone (START). Participants will: * complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life * be randomized to receive either ACES or START rehabilitation program for 10 sessions at their home * repeat part of the tests at the end of the intervention and one month after
Eligibility Criteria
Inclusion Criteria: 1. primary diagnosis of chronic stroke, ≥6 months post onset, 2. ≥18 years old, 3. community-dwelling (i.e., living in a residential setting in the community), 4. restrictions in social participation, indicated by Activity Card Sort (\<80% of pre-stroke activities) Exclusion Criteria: 1. progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy, 2. inability to provide written informed consent, 3. severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale), 4. currently undergoing stroke rehabilitation or mental health intervention (but participation in maintenance sessions, self-help groups, or couples therapy is permitted), 5. major depressive disorder, indicated by PRIME-MD, unless undergoing treatment for at least 4 weeks and are released to participate by their physician or counselor 6. bipolar or psychotic disorder, indicated by PRIME-MD, or 7. substance use disorder within 3 months, indicated by Mini-International Neuropsychiatric Interview
Contact & Investigator
Minmei Shih, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06758505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758505 currently recruiting?
Yes, NCT06758505 is actively recruiting participants. Contact the research team at mis235@pitt.edu for enrollment information.
Where is the NCT06758505 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06758505 clinical trial?
NCT06758505 is sponsored by University of Pittsburgh. The principal investigator is Minmei Shih, PhD at University of Pittsburgh. The trial plans to enroll 54 participants.
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