Oral Screens in Post Stroke Training
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- SCT
研究概览
简要总结
Stroke is a common disease in older people, and often leads to various degrees of disability. Dysphagia is one such consequence which is associated with aspiration pneumonia and malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but the method is insufficiently evaluated. Since treatment with an oral screen is easy, relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to assess the feasibility and efficacy of the intervention. Thus, the aim of the present study is to evaluate the effect of daily oral screen training in post-stroke patients with dysphagia.
A randomized controlled clinical study will be performed in subjects who have had a first stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral screen training for 3 months. In total 70 subjects will be randomized to intervention or control. The changes in swallowing capacity is the main outcome, and secondary outcomes are subjective swallowing problems, lip force, chewing function and quality of life.
Improved oral motor function and decreased dysphagia in post-stroke patients will result in an improved quality of life for the individual, and also reduce hospitalization and health care costs.
详细描述
Project plan Population: Patients are recruited from the hospital Stockholms Sjukhem. When discharged, or 6-7 months after stroke, the patients are informed about the study. All positive answers are registered in a coded list. Patients are contacted by the investigators around eight months after the stroke. Patients are included in the study after informed consent, and if the inclusion criteria are fulfilled.
Inclusion criteria: ≥ 65 years of age. First stroke 8-12 months earlier. Remaining subjective and objective swallowing difficulties. Can eat. Can perform the training by himself/herself or with assistance. Natural teeth corresponding to category A according to Eichner's index.
Exclusion criteria: Moderate to severe impressive aphasia: <4.0 points by A-ning (Aphasia screening tool). Moderate to severe cognitive impairment: <23 points by MoCA (Montreal Cognitive Assessment). Unilateral neglect according to the baking tray task.
Procedure: The speech therapist screens the patient with the instruments A-ning, MoCA and Baking tray task. The dentist categorizes their dental status according to Eichner's index. Patients who do not fulfill inclusion criteria are excluded.
The patients are randomized to intervention or control group by central randomization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second stroke 8-12 months earlier.
- •Remaining subjective and objective swallowing difficulties.
- •Can eat. Can perform the training by himself/herself or with assistance from someone.
- •Natural teeth corresponding category A according to Eichner's index
排除标准
- •Moderate to severe impressive aphasia: <4.0 points by A-ning
- •Moderate to severe cognitive impairment: <23 by MoCA
- •Unilateral neglect according to baking tray task
结局指标
主要结局
SCT
时间窗: Change from baseline swallowing capacity baseline at 3 mo
Swallowing capacity test
次要结局
- Lip force(Change from baseline lip force at Month 3)
- QoL(Change from baseline LiSat at Month 3)
- Chewing function(Change from baseline mixing efficiency at Month 3)
研究者
Gunilla Sandborgh Englund
professor
Karolinska Institutet