Adaptive Trial Scheduling in Naming Treatment for Aphasia

Официальное название

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)

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 2, which will evaluate the benefits of adaptive trial spacing.

Подробное описание

Study 2: Evaluate the benefits of adaptive trial scheduling.

Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling condition to two non-adaptive conditions. For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. Participants will receive 10 weeks of computer-based training per condition, with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment. Condition order will be randomly assigned and counter-balanced across participants. In total, Study 2 will include typically 3-4 (but up to 6) assessment sessions, 120 one-on-one treatment sessions, and 24 baseline and follow-up probe sessions per participant over an \~1-year period, or up to 18 months. All assessment, treatment, and probe sessions will take place via telehealth.

Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. The treatment phase for each of the three conditions will consist of ten weeks of one-on-one treatment four times per week in which the treating clinician will work alongside participants to complete flashcard practice four days a week. The treatment sessions will each last 30 minutes to approximate realistic treatment dosage in outpatient or home health practice settings. Treatment will consist of effortful retrieval practice: on each trial, participants will see a picture of the target and attempt to name it, then rate their naming accuracy by button press. The experimenter will code their response time and perceived accuracy. Finally, the experimenter will code their accuracy which will reveal the target in verbal and written form. If they are unable to name the word correctly, they will be able to replay the answer and repeat it three times prior to moving on to the next trial, per Conroy et al.

Вмешательства

• Поведенческое Adaptive Spacing Condition
  Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increa
• Поведенческое High-Item Non-Adaptive Spacing Condition
  Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
• Поведенческое Low-Item Non-Adaptive Spacing Condition
  Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Первичные конечные точки

• Change in correct responses in Confrontation Naming of Treated and 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]

Вторичные конечные точки (3)

• 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 stroke.
• Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.
• Must have access to a high-speed internet connection and be able to participate in telehealth.

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

Идентификаторы

NCT: NCT05653466 · STUDY21120130 (Study 2) · 1R01DC019325-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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