The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
研究概览
简要总结
The purpose of this study is to conduct a randomized clinical trial that assesses the efficacy and cost-effectiveness of an Intensive Comprehensive Aphasia Program (ICAP), specifically focusing on the variable of intensity. Half of the participants will receive 60 hours of intensive treatment over three weeks, while the other half will receive the same amount and type of comprehensive treatment distributed over 15 weeks.
详细描述
Recent research has emphasized the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery and rehabilitation following a stroke. Furthermore, studies have indicated that intensive aphasia treatment is more efficacious than less intensive treatment. Rather than being influenced by such evidence, the reality is that public and private payers are drastically reducing services to persons with aphasia (PWA). Legislation has seriously curtailed the amount of treatment a PWA may receive after hospitalization. Often patients are eligible for only a limited number of treatment sessions over a limited period of time. In some cases, they may not receive any treatment for their communication disorder following their acute hospitalization. Reduced resources (e.g. transportation difficulties, therapist shortages in rural areas) also may severely limit available services.
The Intensive Comprehensive Aphasia Program (ICAP) may be a creative, cost-effective and sustainable option for delivering meaningful and necessary aphasia services. Despite the growing numbers of ICAPs, there is little evidence about their efficacy, effectiveness, or cost-effectiveness. All stakeholders need this evidence. Funding agencies require evidence to make decisions about their investments in aphasia rehabilitation. People with aphasia and their families should have evidence prior to investing their money and time into such programs, and speech and language pathologists have an ethical obligation to provide evidence-based practices.
Based on evidence regarding treatment intensity that has translated principles of neuroplasticity from animal models to stroke recovery, the investigators hypothesize that 60 hours of comprehensive treatment will result in significant improvements in (a) performance-based, (b) client-reported, and (c) surrogate-reported assessments of communication skills, community participation, and health-related quality of life. They also hypothesize that when 60 hours of comprehensive treatment is provided intensively over 3 weeks, the magnitude and rate of improvement as well as the extent to which improvements are maintained will be greater than when the 60 hours of comprehensive treatment is distributed over 15 weeks. Because the investigators hypothesize that the magnitude and rate of improvement will be greater with the intensive ICAP than with the distributed ICAP, they further hypothesize that the intensive ICAP will be more cost-effective than the distributed ICAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Because of the nature of the intervention, neither the treating SLPs nor the subjects can be masked regarding the scheduling of treatment. To minimize outcome ascertainment bias, an evaluator (testing speech-language pathologist) who is not directly associated with the daily activities of the trial and, therefore, blind to the treatment arm will administer and score all the assessments. Subjects will be introduced to the treatment arm to which they have been assigned with a script that emphasizes similar expectations from the intervention, regardless of the treatment group. This will reduce subject bias resulting from such beliefs that one of the therapies is less effective.
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
- •diagnosis of an aphasia subsequent to a left-hemisphere infarct that is confirmed by CT scan or MRI
- •an Aphasia Quotient score on the Western Aphasia Battery of 20-
- •6 months post injury
- •premorbidly fluent in English
- •receiving no concomitant speech-language therapy
排除标准
- •diagnosis of Global aphasia
- •any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's disease and other dementias, or traumatic brain injury
- •any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization (subjects with mood disorders who are currently stable on treatment will be considered)
- •active substance abuse.
研究组 & 干预措施
Intensive Comprehensive Aphasia Program
60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks.
干预措施: Speech and Language Therapy (Behavioral)
Distributed Comprehensive Aphasia Tx
60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week).
干预措施: Speech and Language Therapy (Behavioral)
结局指标
主要结局
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
时间窗: Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Includes a measure of auditory comprehension, oral expression, reading and written expression skills. Change from baseline to post-treatment and follow-up is reported.
次要结局
- The Communicative Effectiveness Index (CETI)(Change from pre-treatment to 3 month follow-up)
- The Communication Confidence Rating Scale for Aphasia (CCRSA)(Change from pre-treatment to 3 month follow-up)
- Assessment for Living with Aphasia (ALA)(Change from pre-treatment to 3 month follow-up)
- Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)(Change from pre-treatment to 3 month follow-up)
- Assessment for Living with Aphasia (ALA)(Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment))
- The Communication Confidence Rating Scale for Aphasia (CCRSA)(Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment))
- The Communicative Effectiveness Index (CETI)(Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment))
研究者
Leora Cherney
Scientific Chair, Think & Speak Lab
Shirley Ryan AbilityLab