Меню
Идёт набор NCT06758505

Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

Без фазы С лечением Stroke Chronic Phase of Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Strategy Training Only, Strategy Training embedded with Acceptance and Commitment Therapy Principles.
Кому может быть актуально
Состояния в реестре: Stroke, Chronic Phase of Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое Strategy Training Only
    Participants will receive ten 45-60-minute sessions (two times per week) in person in their residence to address real-world performance with an emphasis on START strategy, task-specific practice, and guided discovery to perform social participation activities. In session 1, participants will be guided to select 3 to 5 meaningful social activities and prioritize them. In sessions 2 - 9, participants will use structured START strategy worksheet to try the selected activity; assess execution (e.g.,
  • Поведенческое Strategy Training embedded with Acceptance and Commitment Therapy Principles
    Participants will receive ten 45-60-minute sessions (two times per week) in person in their residence to address real-world performance with task-specific practice and an emphasis on psychological processes using ACT principles. In session 1, participants will clarify value-consistent social participation goals for engaging in 3-5 meaningful activities ("Do What Matters"). In sessions 2-9, participants will be guided applying ACT principles to cope with negative experiences and separate self fro

Первичные конечные точки

  • Feasibility: Fidelity (for each group) [Срок оценки: Baseline to Post-intervention up to 8 weeks]
  • Feasibility: Satisfaction (for each group) [Срок оценки: Baseline to Post-intervention up to 8 weeks]
Вторичные конечные точки (4)
  • Changes in social participation: Difficulty to participate in social activities [Срок оценки: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
  • Changes in social participation: Satisfaction with social participation [Срок оценки: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
  • Changes in psychological flexibility [Срок оценки: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]
  • Changes in wellbeing [Срок оценки: Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks]

Критерии участия

Критерии включения

  • primary diagnosis of chronic stroke, ≥6 months post onset,
  • ≥18 years old,
  • community-dwelling (i.e., living in a residential setting in the community),
  • restrictions in social participation, indicated by Activity Card Sort (<80% of pre-stroke activities)

Критерии исключения

  • progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy,
  • inability to provide written informed consent,
  • severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale),
  • currently undergoing stroke rehabilitation or mental health intervention (but participation in maintenance sessions, self-help groups, or couples therapy is permitted),
  • 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
  • bipolar or psychotic disorder, indicated by PRIME-MD, or
  • substance use disorder within 3 months, indicated by Mini-International Neuropsychiatric Interview

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06758505 · STUDY24030133 · R03HD114635

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗