The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of a tablet-based aphasia therapy via the recruitment rate
研究概览
简要总结
As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.
详细描述
The study is a prospective study, with each participant undergoing testing approximately within three days after inclusion in the study (immediately prior to tablet-based aphasia therapy). Based on the results of diagnostic testing (standard of care in the acute phase), therapy will be tailored for each individual. After two short training sessions, patients will independently practice with the app during hospitalisation, guided by a user-friendly instruction sheet. Patients will be encouraged to practice as much as possible, with a minimum of 30 minutes per day. Exercises will be selected by the speech-language therapist based on diagnostic results and will be adjusted for difficulty and type of exercise during treatment based on performance rates. the aim of the study is to investigate the feasibility, usability and acceptability of a tablet-based aphasia therapy in patients with aphasia in the acute phase following stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with aphasia after an ischemic or hemorrhagic stroke
- •Maximum 2 weeks post-stroke
- •Minimum 18 years old
- •A minimum proficient language level of Dutch
- •Imaging (CT or MRI) prior to inclusion
- •Signed informed consent
排除标准
- •Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy
结局指标
主要结局
Feasibility of a tablet-based aphasia therapy via the recruitment rate
时间窗: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll
Feasibility of a tablet-based aphasia therapy via the retention rate
时间窗: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Retention rate: number of patients continuing to use the mobile tablet until the time of discharge + notation of reasons why patients did not continue practicing
Feasibility of a tablet-based aphasia therapy via the adherence rate,
时间窗: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time
Feasibility of a tablet-based aphasia therapy via protocol deviations
时间窗: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Notation of any protocol deviations
Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,
时间窗: date of hospital discharge, an average of 1 week
Self-prepared usability questionnaire: patients will need to fill in a 5 question survey (5-point Likert scale) measuring the usability of a tablet-based therapy. Minimum score is 1 (= totally not agree), maximum score is 5 (= totally agree)
Usability of a tablet-based aphasia therapy via an observational checklist
时间窗: date of hospital discharge, assessed up to 20 weeks
Self-prepared observational checklist: patients will be observed during a therapy session. Different sub-tasks will be scored for independency on a 3-point scale. Minimum score is 1 (completely dependent), maximum score is 3 (= completely independent)
Usability of a tablet-based aphasia therapy via within-task improvements of the app
时间窗: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Notation of exercises performed with the app
Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction
时间窗: date of hospital discharge, an average of 1 week
Vertical visual anologue scale (VAS) for satisfaction: patients have to indicate their general level of satisfaction post-intervention on a vertical VAS-scale. Minimum score is 0 (= not satisfied), maximum score is 100 (= very satisfied)
次要结局
未报告次要终点
研究者
Neurologie
Principal Investigator, clinical professor Veerle De Herdt
University Hospital, Ghent