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Идёт набор NCT05653440

Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia

Фаза II С лечением Aphasia Stroke

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: Accuracy-maximized condition, Effort-maximized condition, Effort-accuracy balanced condition.
Кому может быть актуально
Состояния в реестре: Aphasia, Stroke. 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 →
Официальное название

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 1: Balancing Effortful and Errorless Learning Via Adaptive Naming Deadlines)

Обзор

Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life. This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.

Подробное описание

Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.

* Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes typically 3-4 (but up to 6) assessment sessions, 24 treatment sessions, and 24 baseline and follow-up probe assessment sessions per participant over an approximately 10-month period, but up to 18 months. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers). * Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia \>6 months post- onset of aphasia due to left-hemisphere ischemic or hemorrhagic stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with a history of other acquired or progressive neurological disease, significant language comprehension impairments, unmanaged drug/alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized mental health interventions. * Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response. * Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.

Вмешательства

  • Поведенческое Accuracy-maximized condition
    Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
  • Поведенческое Effort-maximized condition
    Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
  • Поведенческое Effort-accuracy balanced condition
    Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.

Первичные конечные точки

  • Change in correct responses in Confrontation Naming of Treated Pictured Objects [Срок оценки: Initial assessment (pre-treatment), 3 months post-treatment]
Вторичные конечные точки (5)
  • Change in correct responses in Confrontation Naming of Untreated Pictured Objects [Срок оценки: Initial assessment (pre-treatment), 3 months post-treatment]
  • Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects [Срок оценки: Initial assessment (pre-treatment), 3 months post-treatment]
  • Change in core lexicon analysis on the Aphasia Bank Discourse Protocol [Срок оценки: Initial assessment (pre-treatment), 3-months post-treatment]
  • Change in mean scores on the Aphasia Communication Outcome Measure Short-Form [Срок оценки: Initial assessment (pre-treatment), 1 week post-treatment.]
  • Score on the Adapted Intrinsic Motivation Inventory for Aphasia [Срок оценки: 1 week post-treatment]

Критерии участия

Критерии включения

  • Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere ischemic or hemorrhagic stroke.
  • Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.

Критерии исключения

  • History of other acquired or progressive neurological disease.
  • Significant language comprehension impairments
  • Unmanaged drug / alcohol dependence.
  • Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, Scho — Pittsburgh

Публикации

  • van der Stelt CM, Cavanaugh R, Hula WD, Starns J, Kelly A, Goodman ML, Terhorst L, Hassany M, Brusilovsky P, Evans WS. Adaptive balancing of effort, accuracy and response speed in anomia treatment for post-stroke aphasia in community-based settings in the USA: a within-subjects randomised controlled trial protocol. BMJ Open. 2026 May 20;16(5):e116172. doi: 10.1136/bmjopen-2025-116172. PMID 42161555

Идентификаторы

NCT: NCT05653440 · STUDY21120130 (Study 1) · 1R01DC019325-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗