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Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Description

In April 2025, the investigator changed the recruitment status because the first enrolled participant ended up being ineligible. The investigators also updated eligibility criteria and outcome measures to be consistent with the IRB protocol.

In June 2025, the investigator received notice of award from NIH and thus updated information to be consistent with the IRB protocol.

Eligibility

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

Study details
    Stroke
    Chronic Phase of Disease

NCT06758505

University of Pittsburgh

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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