跳至主要内容
临床试验/NCT05653440
NCT05653440招募中2 期

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

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月27日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
30
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 1, which will adaptively balance effort and accuracy using speeded naming deadlines.

详细描述

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.

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

入选标准

  • 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.

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.

研究组 & 干预措施

Effort-maximized, then accuracy-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Effort-maximized, then accuracy-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Effort-maximized, then accuracy-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Effort-maximized, then effort-accuracy balanced, then accuracy-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

Accuracy-maximized, then effort-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Accuracy-maximized, then effort-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Accuracy-maximized, then effort-maximized, then effort-accuracy balanced

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Accuracy-maximized, then effort-accuracy balanced, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

Effort-accuracy balanced, then effort-maximized, then accuracy maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Effort-accuracy balanced, then effort-maximized, then accuracy maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Effort-accuracy balanced, then effort-maximized, then accuracy maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

Effort-accuracy balanced, then accuracy-maximized, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Accuracy-maximized condition (Behavioral)

Effort-accuracy balanced, then accuracy-maximized, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-maximized condition (Behavioral)

Effort-accuracy balanced, then accuracy-maximized, then effort-maximized

Experimental

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

干预措施: Effort-accuracy balanced condition (Behavioral)

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.

Change in correct responses in Confrontation Naming of Treated Pictured Objects

时间窗: Initial assessment (pre-treatment), 3 months post-treatment

Confrontation naming accuracy of pictures targeted in each training condition 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 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 correct responses in Confrontation Naming of Untreated Pictured Objects(Initial assessment (pre-treatment), 3 months post-treatment)
  • Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects(Initial assessment (pre-treatment), 3 months 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

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Evans

Assistant Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验