Defining Trajectories of Linguistic, Cognitive-Communicative, and Quality of Life Outcomes in Aphasia: Longitudinal Observational Study Protocol

Leora R. Cherney PhD , Allan J. Kozlowski PhD , Andrea A. Domenighetti PhD , Marwan N. Baliki PhD , Mary J. Kwasny ScD , Allen W. Heinemann PhD
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Abstract

Objective

To describe the trajectories of linguistic, cognitive-communicative, and health-related quality of life (HRQOL) outcomes after stroke in persons with aphasia.

Design

Longitudinal observational study from inpatient rehabilitation to 18 months after stroke.

Setting

Four US mid-west inpatient rehabilitation facilities (IRFs).

Participants

We plan to recruit 400 adult (older than 21 years) English speakers who meet the following inclusion criteria: (1) Diagnosis of aphasia after a left-hemisphere infarct confirmed by CT scan or magnetic resonance imaging (MRI); (2) first admission for inpatient rehabilitation due to a neurologic event; and (3) sufficient cognitive capacity to provide informed consent and participate in testing. Exclusion criteria include any neurologic condition other than stroke that could affect language, cognition or speech, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, or the presence of right-hemisphere lesions.

Interventions

Not applicable.

Main Outcome Measures

Subjects are administered a test battery of linguistic, cognitive-communicative, and HRQOL measures. Linguistic measures include the Western Aphasia Battery-Revised and the Apraxia of Speech Rating Scale. Cognitive-communicative measures include the Communication Participation Item Bank, Connor's Continuous Performance Test-3, the Communication Confidence Rating Scale for Aphasia, the Communication Effectiveness Index, the Neurological Quality of Life measurement system (Neuro-QoL) Communication short form, and the Neuro-QoL Cognitive Function short form. HRQOL measures include the 39-item Stroke & Aphasia Quality of Life Scale, Neuro-QoL Fatigue, Sleep Disturbance, Depression, Ability to Participate in Social Roles & Activities, and Satisfaction with Social Roles & Activities tests, and the Patient-Reported Outcome Measurement and Information System 10-item Global Health short form. The test battery is administered initially during inpatient rehabilitation, and at 3-, 6-, 12-, and 18-months post-IRF discharge. Biomarker samples are collected via saliva samples at admission and a subgroup of participants also undergo resting state fMRI scans.

Results

Not applicable.

Conclusions

This longitudinal observational study will develop trajectory models for recovery of clinically relevant linguistic, cognitive-communicative, and quality of life outcomes over 18 months after inpatient rehabilitation. Models will identify individual differences in the patterns of recovery based on variations in personal, genetic, imaging, and therapy characteristics. The resulting models will provide an unparalleled representation of recovery from aphasia resulting from stroke. This improved understanding of recovery will enable clinicians to better tailor and plan rehabilitation therapies to individual patient's needs.

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定义失语症患者的语言、认知-交流和生活质量结果轨迹:纵向观察研究方案
目的描述中风后失语症患者的语言、认知-交流和健康相关生活质量(HRQOL)结果的轨迹.设计从住院康复到中风后 18 个月的纵向观察研究.地点美国中西部四家住院康复机构(IRFs).参与者我们计划招募 400 名符合以下纳入标准的成年(21 岁以上)英语使用者:(1) 经 CT 扫描或磁共振成像 (MRI) 确认为左半球梗塞后诊断为失语症;(2) 因神经系统事件首次入院接受住院康复治疗;(3) 具有足够的认知能力,能够提供知情同意并参与测试。排除标准包括除中风以外的任何可能影响语言、认知或言语的神经系统疾病,如帕金森病、阿尔茨海默病、脑外伤或存在右半球病变。主要结果测量对受试者进行语言、认知-交流和 HRQOL 测量测试。语言测量包括西方失语症测验(Western Aphasia Battery-Revised)和语言障碍评分量表(Apraxia of Speech Rating Scale)。认知-交流测量包括 "交流参与项目库"(Communication Participation Item Bank)、"康纳连续表现测试-3"(Connor's Continuous Performance Test-3)、"失语症交流信心评级量表"(Communication Confidence Rating Scale for Aphasia)、"交流有效性指数"(Communication Effectiveness Index)、"神经系统生活质量测量系统"(Neuro-QoL)交流简表和 "神经系统生活质量测量系统 "认知功能简表。HRQOL 测量包括 39 项脑卒中和失语症生活质量量表、神经-QoL 疲劳、睡眠障碍、抑郁、参与社会角色和活动的能力、对社会角色和活动的满意度测试,以及患者报告结果测量和信息系统 10 项全球健康简表。测试在住院康复期间、IRF 出院后 3 个月、6 个月、12 个月和 18 个月进行。入院时通过唾液样本收集生物标志物样本,一部分参与者还接受了静息状态 fMRI 扫描。结果不适用。结论这项纵向观察研究将为住院康复后 18 个月内临床相关语言、认知-交流和生活质量的恢复建立轨迹模型。模型将根据个人、遗传、影像和治疗特点的不同,确定康复模式的个体差异。由此产生的模型将为中风导致的失语症的康复提供无与伦比的表征。对康复的进一步了解将使临床医生能够更好地根据患者的个人需求定制和规划康复疗法。
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