Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia

Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Deglutition Disorders; Rehabilitation; Video Game
• Intervention / Treatment: Device: Video-game; Behavioral: Conventional therapy

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bohan Ms. Zhang; Phone Number: 852 61132553; Email: bohan.zang@connect.polyu.hk

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Beijing Xiaotangshan Hospital
    • Contact: Yue Liu, BsN; Email: 1131364506@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-game group; Received the video-game intervention	Device: Video-game; The video-game has three games: (1) Game One - Lip Exercise; (2) Game Two - Tongue Exercises; (3) Game Three - Lower Jaw Exercise. The whole training will take about once a day for 30 min per session, 5 times a week for 4 weeks.
Active Comparator: Conventional therapy group; Received the conventional therapy intervention	Behavioral: Conventional therapy; The control group used the conventional swallowing function training. The lip exercise consisted of the following specific movements: opening mouth, closing mouth, drumming cheeks, left drumming cheeks, and right drumming cheeks; the tongue exercise consisted of the following specific movements: extending the tongue, tongue up, tongue down, tongue left, and tongue right. Each specific movement in the steps lasts 2-3s, repeat 15 times and continue with the next movement. The lower jaw movement contains the following specific movements: keep the head as low as possible, and squeeze the rubber ball placed on the neck for 2-3 seconds, repeat 15 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Toronto Bedside Swallowing Screening Test (TOR-BSST)	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.	Assessments were conducted at baseline, within 1 week post-training, and week 8.
the Functional Oral Intake Scale (FOIS)	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.	Assessments were conducted at baseline, within 1 week post-training, and week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The swallowing quality of life (SWAL-QOL) questionnaire	The swallowing quality of life (SWAL-QOL) questionnaire consists of 10 subscales and a symptom scale (14 items) to assess the severity of dysphagia symptoms. Scores range from 0 to 100, with lower scores indicating greater impairment of quality of life from dysphagia	Assessments will be conducted at baseline, within 1 week post-training, and week 8.
The acceptance survey questionnaire	The acceptance survey questionnaire was self-designed based on reference to relevant literature, and was repeatedly modified by experts, and consisted of two parts: (1) Basic information: including age, gender, education level, type of work, and disease; (2) Acceptance of video-game based swallowing training: the widely used Technology Acceptance Model (TAM) as a theoretical model , seven dimensions of perceived usefulness, perceived ease of use, perceived ease of learning, perceived applicability, perceived safety, perceived satisfaction, and intension to use, with five questions under each dimension, each scored on a scale of 1 to 5, with 1 being "strongly disagree", 2 being "basically disagree", 3 being "unsure", 4 being "basically agree", and 5 being "strongly agree" , Scores range from 15 to 75, with higher scores indicating that participants are more receptive to video games.	Assessments will be conducted within 1 week post-training.
Body mass index (BMI)	Body mass index is one of the most commonly used nutritional assessments among adults.BMI is equal to weight (kg) divided by height (meters squared). Under normal conditions, the BMI is generally between 18 and 24 as normal. When it is lower than 18, it is called underweight; when it is more than 24, it is called overweight; when it is more than 28, it is called obese.	Assessments will be conducted at baseline, within 1 week post-training, and week 8.
Mini Nutritional Assessment Short Form (MNA-SF)	Mini Nutritional Assessment Short Form (MNA-SF) were used to assess the nutritional status of the dysphagia patients. Scores range from 0 to 14, with >11 identified as malnutrition, ≤11 as normal.	Assessments will be conducted at baseline, within 1 week post-training, and week 8.
The satisfaction questionnaire	The satisfaction questionnaire was designed based on the literatures. There are 15 items, involving 3 dimensions: training mode content setting, training mode format setting, and self-subjective feeling, and scored on a 5-point Likert scale. Scores range from 5 to 15. The higher the score, the more satisfied the patients were with the video-game training.	Assessments will be conducted within 1 week post-training.
Adherence	Adherence was based on the actual completion of the patient's swallowing function training. The actual completion of the dysphagia training by patients, including the number of training sessions completed and the duration of training, was objectively recorded by the researcher. Adherence was considered good if the patient could complete more than 80% of the training sessions of the corresponding training program; average if the patient could complete 50% to 80% of the training sessions; and poor if the patient could complete less than 50% of the training sessions. Patients are considered to have completed their training when they have completed more than 12 training sessions.	Assessments will be within 1 week post-training.
Self-efficacy	The General Self-Efficacy Scale were used to assess participants' perceptions of learning, with 10 items and scores ranging from 10 to 50, with higher scores indicating higher self-efficacy among participants.	Assessments will be conducted at baseline, within 1 week post-training.
Learned helplessness	The Learned Helplessness Scale was used to assess participants' feelings of powerlessness over learning, with 18 items and scores ranging from 18 to 90, with higher scores indicating greater powerlessness over learning.	Assessments will be conducted at baseline, within 1 week post-training.

Collaborators and Investigators

• Sponsor: ZHANG Bohan

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: HSEARS20230502007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only PI and CI can use IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No