Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- the Functional Oral Intake Scale (FOIS)
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of video-game on swallowing function in patients with dysphagia through a randomized controlled trial and whether it has additional benefits in improving swallowing function and training compliance compared with conventional training methods. The main questions it aims to answer are:
- How effective is video-game based rehabilitation for dysphagia?
- Whether video-game based has additional benefits in improving swallowing function and training compliance compared with conventional training methods Participants will be divided into two groups, with one group completing video game rehabilitation and one group completing conventional rehabilitation.
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)
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
- •first-episode stroke, as confirmed by brain CT or MRI;
- •diagnosis of dysphagia after stroke according to the Toronto Bedside Swallowing Screening Test (TOR-BSST);
- •age between 18 and 80 years;
- •no significant cognitive impairment, able to execute instructions correctly, and with Mini-Mental State Examination (MMSE) score ≥ 24;
- •clear consciousness as assessed by the National Institute of Health stroke scale (NIHSS).
排除标准
- •dysphagia caused by structural lesions (eg, radiotherapy, previous extensive surgery of the head and neck region such as laryngectomy and cordectomy);
- •combined with serious heart, lung, liver, kidney diseases, and hematological disorders;
- •limb deficiency or paralysis, blindness in both eyes, severe visual impairments;
- •motion sickness or vestibular dysfunction;
- •history of epilepsy, malignancy or other neurological diseases;
- •pregnancy or breastfeeding.
研究组 & 干预措施
Video-game group
Received the video-game intervention
干预措施: Video-game (Device)
Conventional therapy group
Received the conventional therapy intervention
干预措施: Conventional therapy (Behavioral)
结局指标
主要结局
the Functional Oral Intake Scale (FOIS)
时间窗: Assessments were conducted at baseline, within 1 week post-training, and week 8.
The Functional Oral Intake Scale consists of a 7-point scale, with level 1 indicating completely impaired oral intake and level 7 indicating complete oral intake regardless of food concentration or type. Scores range from 1 to 7, the higher point means that the participant's oral intake is better.
the Toronto Bedside Swallowing Screening Test (TOR-BSST)
时间窗: Assessments were conducted at baseline, within 1 week post-training, and week 8.
The Toronto Bedside Swallowing Screening Test (TOR-BSST) is the best performing water swallow screening tool 8 with a sensitivity of 91.3%, a negative predictive value of 93.3% in the acute phase and 89.5% in the recovery phase. TOR-BSST has shown to be more convenient and cheaper in bedside screening compared to the gold standard method of simultaneous videofluoroscopy (VFSS), which is an invasive assessment. Due to the limitations of the experimental site, the investigators chose TOR-BSST as the assessment tool for dysphagia.
次要结局
- The swallowing quality of life (SWAL-QOL) questionnaire(Assessments will be conducted at baseline, within 1 week post-training, and week 8.)
- Body mass index (BMI)(Assessments will be conducted at baseline, within 1 week post-training, and week 8.)
- Self-efficacy(Assessments will be conducted at baseline, within 1 week post-training.)
- The acceptance survey questionnaire(Assessments will be conducted within 1 week post-training.)
- Adherence(Assessments will be within 1 week post-training.)
- Mini Nutritional Assessment Short Form (MNA-SF)(Assessments will be conducted at baseline, within 1 week post-training, and week 8.)
- The satisfaction questionnaire(Assessments will be conducted within 1 week post-training.)
- Learned helplessness(Assessments will be conducted at baseline, within 1 week post-training.)
研究者
ZHANG Bohan
Principal Investigator
The Hong Kong Polytechnic University