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临床试验/NCT05338216
NCT05338216已完成不适用

Word Retrieval in the Wild: An Ecological Momentary Assessment Pilot Study in People With Post-Stroke Aphasia

Northeastern University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in Protocol Compliance

研究概览

简要总结

People with post-stroke aphasia (PWA) suffer from anomia, a condition where they know what they want to say but cannot retrieve the words. For PWA, word retrieval changes moment-to-moment, leading to diminished motivation to participate in conversations and disengagement from social interactions. In the real world, anomia variability and severity are compounded by contextual factors of communication exchanges (noise, dual-tasking). Ecological momentary assessment (EMA) involves in-situ measurement of a behavior over time during everyday life. EMA has promise for capturing real-world anomia, yet EMA methods have not been tested in PWA. Therefore, the aims of this pilot study are to (1) determine the relative feasibility of two types of smartwatch-delivered EMA (traditional-EMA and micro-EMA) in PWA and (2) determine the extent to which patient-specific factors relate to feasibility. Twenty PWA will be recruited and randomly assigned to either traditional-EMA or micro-EMA conditions. To target in-situ anomia, PWA will complete 36 picture-naming trials/day for three weeks, delivered either as a single trial 36 times per day (micro-EMA) or in four sets of nine trials/set per day (traditional-EMA). Due to the "at-a-glance" single trial delivery of micro-EMA, the investigators hypothesize that PWA in the micro-EMA condition will demonstrate better protocol adherence than PWA in the traditional-EMA condition. Older age, more severe cognitive-linguistic deficits, and greater discomfort with technology will be related to poorer compliance, lower completion, greater perceived burden, and lower intelligibility of naming audio recordings. This bench-to-bedside research will begin a translational path to implement EMA/micro-EMA into routine assessment of aphasia.

详细描述

BACKGROUND AND TRANSLATIONAL SIGNIFICANCE Background Approximately 15 million individuals worldwide, including 795,000 Americans, suffer a new stroke each year. Aphasia, a disorder characterized by receptive and/or expressive language deficits, affects approximately 30% of stroke survivors and is one of the most devastating post-stroke conditions. Aphasia is a heterogenous disorder, yet anomia (i.e., impaired word retrieval) is a persistent, ubiquitous impairment present in all people with aphasia (PWA). Neurotypical individuals occasionally experience anomia during "tip-of-the-tongue" moments: frustrating instances when someone knows what they want to say but the word itself eludes them. For the two million Americans currently living with aphasia, word retrieval difficulties are far more severe and pervade all communication attempts. Anomia severity ranges between PWA, from mild difficulties such as delayed retrieval of low frequency words (e.g., amulet) to severe difficulty retrieving the names of even common objects (e.g., bed). Yet, regardless of severity, a hallmark of post-stroke anomia is inconsistent word retrieval across attempts for a given word. For PWA, the ability to access words can change day-to-day and even minute-to-minute, resulting in diminished motivation to participate in conversations, disengagement from social interactions, and reduced quality of life.

Per psycholinguistic models of lexical access, naming is a two-step process that involves retrieval of the target's meaning from the semantic system and word form (speech sounds) from the phonological system. Naming failures in PWA result in errors that are related to a target word in meaning (e.g., "carrot" for bean), word form (e.g., "fean" for bean), both meaning and form (e.g., "green" for bean), or neither (e.g., "pencil" for bean; "I know it but I can't say it" for bean) due to insufficient activation of the target meaning/form representations or overactivation of incorrect representations. Due to this noisy system, lexical access is often delayed in PWA, even when the correct word is eventually retrieved. Naming accuracy, response times, and error types provide meaningful information regarding the locus of naming impairment and a patient's recovery capacity. The investigators found that the number of phonological and unrelated errors produced during early post-stroke stages predicted longitudinal changes in naming and global language skills in left hemisphere stroke survivors. Naming errors and the integrity of underlying semantic and phonological systems can also guide language treatment planning. As such, accurate assessment of naming is critical for aphasia care.

In clinical practice, speech-language pathologists (SLPs) typically assess naming deficits through a single administration of a test in a quiet clinic room in a 1:1 interaction between the SLP and patient. Yet, given the variability in word retrieval, a one-time assessment cannot accurately capture the true nature and extent of a patient's anomia. Moreover, unlike a controlled, contrived clinical environment, word retrieval in the real world usually occurs while an individual performs other daily tasks, often in distracting, noisy environments and with many other people present. The added cognitive load of multi-tasking and suppressing external distractors adds to an already noisy lexical system, thereby increasing the chance of delayed or failed word retrieval. Traditional SLP assessment cannot capture the realities of real-world anomia, but the investigators argue that ecological momentary assessment (EMA) can.

EMA is a widely used method in health research to capture longitudinal self-reported behaviors or states of interest (e.g., physical activity, depression, diet) in daily life. In traditional EMA, an electronic device prompts a participant to answer a set of questions (usually via button press) many times a day over time. Answering several questions at a time is time intensive, and thus, a key disadvantage of traditional EMA is interruption burden. In contrast, micro-interaction-based EMA (µEMA) reduces each prompt to a single question that can be answered in ~3-5s, allowing for many more questions interspersed over time. The investigators' pilot studies suggest that even with an interruption rate eight times more than traditional EMA, µEMA has higher response rates and lower perceived burden than traditional EMA. Furthermore, µEMA yields temporally dense in-situ measures, making it an ideal tool for capturing the variability of anomia in the daily lives of PWA. One caveat is that an anomia µEMA/EMA protocol would necessitate recording verbal responses, yet traditional EMA and µEMA protocols to date have only required nonverbal responses via a button press or screen tap. The feasibility of capturing high-quality audio responses in a µEMA or traditional EMA protocol is unknown.

Moreover, despite the increasing use of technology-based assessments and therapy platforms for aphasia, neither electronically delivered EMA nor µEMA has been tested in PWA. In fact, based on a review from 2020, only seven studies have used EMA to study stroke recovery and none targeted language impairments. A central question is whether stroke survivors with aphasia can adhere to electronically delivered traditional EMA or µEMA anomia protocols. Prior research regarding tablet and computer-based platforms for aphasia indicates that PWA with better visuospatial attention and executive functions are better able to learn how to navigate a novel iPad application. Evidence suggests that SLP support is associated with greater adherence to a computerized therapy program for PWA and that patients' perceived engagement in the computer program is related to opportunities for practice, their ability to use the technology, and their motivation. An important step towards broader implementation of EMA and/or µEMA in aphasia is determining PWA's adherence to such protocols and which patient-specific factors are associated with protocol adherence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

The participants will not be told explicitly that there are two arms or which arm they are in.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current/pre-stroke English proficiency,
  • Normal/corrected-to-normal vision and hearing,
  • Medical stability,
  • History of left hemisphere stroke at least six months prior to enrollment, and
  • Presence of aphasia

排除标准

  • History of neurological disease affecting the brain other than stroke

研究组 & 干预措施

Traditional Ecological Momentary Assessment (Traditional EMA)

Experimental

People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.

干预措施: Traditional EMA (Behavioral)

Micro-Interaction Ecological Momentary Assessment (µEMA)

Experimental

People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.

干预措施: Micro-Interaction EMA (Behavioral)

结局指标

主要结局

Change in Protocol Compliance

时间窗: Every day over the three-week at-home smartwatch naming protocol

Compliance will be determined by considering the total number of YES button responses to the "Ready?" screen over the total number of scheduled prompts. This measure will include trials that are missed due to the watch being uncharged or turned off, an important aspect of protocol adherence.

Change in Protocol Completion

时间窗: Every day over the three-week at-home smartwatch naming protocol

Completion will reflect participants' ability to adhere to each step of the smartwatch prompt, including pressing the YES button to the "Ready?", looking at the pictured object(s), and attempting to name the picture(s) aloud. Completion will be determined by considering the total number of naming attempts (indexed by the number of trials for which the participants' voice is audible on the audio recording, disregarding intelligibility of the response) over the total number of prompts delivered to the watch; this measure will exclude trials that are missed due to the watch being uncharged or off.

Change in Audio Intelligibility

时间窗: Every day over the three-week at-home smartwatch naming protocol

An objective measure of speech intelligibility of audio recordings will be obtained by SLP graduate student RAs manually coding each picture naming audio clip. While the task is a single-word naming task, PWA often produce more than one word in their attempt to name a picture (e.g., "uh asparagus no um green...um bean!" to a picture of bean). It is possible that only part of a multi-word response will be intelligible. Audio clips will be coded as being either completely intelligible (1) or partially/completely unintelligible (0). For each participant, the percentage of intelligible responses will be calculated using the following formula: (\[sum of intelligible responses\] / \[sum of all responses\])\*100.

Change in Protocol Compliance

时间窗: Every day over the three-week at-home smartwatch naming protocol

Compliance will be determined by considering the total number of YES button responses to the "Ready?" screen over the total number of scheduled prompts. This measure will include trials that are missed due to the watch being uncharged or turned off, an important aspect of protocol adherence.

Change in Protocol Completion

时间窗: Every day over the three-week at-home smartwatch naming protocol

Completion will reflect participants' ability to adhere to each step of the smartwatch prompt, including pressing the YES button to the "Ready?", looking at the pictured object(s), and attempting to name the picture(s) aloud. Completion will be determined by considering the total number of naming attempts (indexed by the number of trials for which the participants' voice is audible on the audio recording, disregarding intelligibility of the response) over the total number of prompts delivered to the watch; this measure will exclude trials that are missed due to the watch being uncharged or off.

Change in Audio Intelligibility

时间窗: Every day over the three-week at-home smartwatch naming protocol

An objective measure of speech intelligibility of audio recordings will be obtained by SLP graduate student RAs manually coding each picture naming audio clip. While the task is a single-word naming task, PWA often produce more than one word in their attempt to name a picture (e.g., "uh asparagus no um green…um bean!" to a picture of bean). It is possible that only part of a multi-word response will be intelligible. Audio clips will be coded as being either completely intelligible (1) or partially/completely unintelligible (0). For each participant, the percentage of intelligible responses will be calculated using the following formula: (\[sum of intelligible responses\] / \[sum of all responses\])\*100.

次要结局

  • Change in Perceived Burden(Once per week over the three-week at-home smartwatch naming protocol)
  • Change in Perceived Burden(Once per week over the three-week at-home smartwatch naming protocol)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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