A Parallel, Virtual, Randomized Trial of PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
研究概览
简要总结
Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders.
The entire study, including recruitment, enrollment, assessment and treatment were conducted remotely.
The proposed pilot study seeks to compare performance of PCT therapy vs. conventional workbook intervention for stroke patients. The investigators hypothesize that the experimental (PCT) group will experience greater gains on the WAB-AQ at follow-up compared to baseline compared to a control (workbook) group.
Subjects were prospectively assigned to an experimental or active control group in a random order with both groups balanced for their baseline level of speech, language and/or cognitive ability:
- Experimental Group: Participants were instructed to use PCT for at least 30 minutes/day, 5 days/week. Performance and usage data were automatically reported by the PCT software to the treating clinician and was used to modify task assignment over time and monitor participant adherence to the treatment program.
- Active Control Group: Participants were provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia; Brubaker, 2006) that are typically used by clinicians with persons with aphasia (PWA) for at least 30 minutes/day, 5 days/week. Notably, the control procedure employed here is similar to a large-scale study examining technology as a treatment option by Palmer and colleagues (2015).
The treatment period was 10 weeks. All participants received a bimonthly check-in through video-chat with a member of the research staff during the treatment period.
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
- None
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
- •Have diagnosis of stroke involving a hemorrhage or ischemic event, resulting in speech, language, and/or cognitive deficits
- •Have time post-stroke of at least 4 months prior to enrollment
- •Have been discharged from rehabilitation hospital
- •Are adults (aged 18 years or older) at the time of consent
- •Exhibit clinically confirmed speech, language, and/or cognitive deficits based on medical records
- •Are fluent English speakers
- •Have confirmed aphasia using the WAB-R Aphasia Quotient (score of 90 or lower; 93.8 is cutoff for normal scores)
- •Have a presence of a family member or caregiver who is willing and able to provide assistance during the duration of study period
排除标准
- •Have comorbid neurological conditions that could impair study participation in the opinion of the investigator, such as dementia or Parkinson's disease
- •Currently require inpatient care or acute care
- •Are currently undergoing related one-on-one individual therapy at a hospital, rehabilitation facility, university, or at home
- •Exhibit severe apraxia of speech or severe dysarthria of speech, as verified by a clinician and confirmed by the WAB-R (and the Screen for Dysarthria and Apraxia of Speech if necessary), and/or medical records
- •Have comorbid psychiatric conditions that could impair study participation in the opinion of the investigator, including such as schizophrenia or major depressive disorder, as indicated by medical records
- •Have uncorrected hearing or vision loss
结局指标
主要结局
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
时间窗: Follow-up assessment 10-12 weeks post baseline
The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.
次要结局
- Western Aphasia Battery Revised, Language Quotient (WAB-LQ)(Follow-up assessment 10-12 weeks post baseline)
- Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)(Follow-up assessment 10-12 weeks post baseline)
- Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)(Follow-up assessment 10-12 weeks post baseline)
- Brief Test of Adult Cognition by Telephone (BTACT)(Follow-up assessment 10-12 weeks post baseline)
研究者
Michelle Braley
Primary Investigator/Senior Manager of Clinical Science
The Learning Corp