Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants responsible for coding data will be masked to treatment condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
时间窗: Initial assessment (pre-treatment), 3 months post-treatment
Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
时间窗: Initial assessment (pre-treatment), 3 months post-treatment
Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a primary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.
次要结局
- Change in mean scores on the Aphasia Communication Outcome Measure Short-Form(Initial assessment (pre-treatment), 1 week post-treatment.)
- Change in core lexicon analysis on the Aphasia Bank Discourse Protocol(Initial assessment (pre-treatment), 3 months post-treatment)
- Change in mean scores on the Aphasia Communication Outcome Measure Short-Form(Initial assessment (pre-treatment), 1 week post-treatment.)
- Score on the Adapted Intrinsic Motivation Inventory for Aphasia(1 week post-treatment)
研究者
William Evans
Assistant Professor
University of Pittsburgh