Clinical trial NCT05978700: Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia
Official title: Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deglutition Disorders
Rehabilitation
Video Game
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. first-episode stroke, as confirmed by brain CT or MRI;
2. diagnosis of dysphagia after stroke according to the Toronto Bedside Swallowing Screening Test (TOR-BSST);
3. age between 18 and 80 years;
4. no significant cognitive impairment, able to execute instructions correctly, and with Mini-Mental State Examination (MMSE) score ≥ 24;
5. clear consciousness as assessed by the National Institute of Health stroke scale (NIHSS).

Exclusion Criteria:

1. dysphagia caused by structural lesions (eg, radiotherapy, previous extensive surgery of the head and neck region such as laryngectomy and cordectomy);
2. combined with serious heart, lung, liver, kidney diseases, and hematological disorders;
3. limb deficiency or paralysis, blindness in both eyes, severe visual impairments;
4. motion sickness or vestibular dysfunction;
5. history of epilepsy, malignancy or other neurological diseases;
6. pregnancy or breastfeeding.

Primary outcomes:
measure: the Toronto Bedside Swallowing Screening Test (TOR-BSST)
timeFrame: Assessments were conducted at baseline, within 1 week post-training, and week 8.
measure: the Functional Oral Intake Scale (FOIS)
timeFrame: Assessments were conducted at baseline, within 1 week post-training, and week 8.
Secondary outcomes:
measure: The swallowing quality of life (SWAL-QOL) questionnaire
timeFrame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
measure: The acceptance survey questionnaire
timeFrame: Assessments will be conducted within 1 week post-training.
measure: Body mass index (BMI)
timeFrame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
measure: Mini Nutritional Assessment Short Form (MNA-SF)
timeFrame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
measure: The satisfaction questionnaire
timeFrame: Assessments will be conducted within 1 week post-training.
measure: Adherence
timeFrame: Assessments will be within 1 week post-training.
measure: Self-efficacy
timeFrame: Assessments will be conducted at baseline, within 1 week post-training.
measure: Learned helplessness
timeFrame: Assessments will be conducted at baseline, within 1 week post-training.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Xiaotangshan Hospital
Study officials:
References: