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

NCT05978700 | Completed DMC

• 1 other identifier: HSEARS20230502007
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders; Rehabilitation; Video Game

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The swallowing quality of life (SWAL-QOL) questionnaire

  Assessments will be conducted at baseline, within 1 week post-training, and week 8.

• The acceptance survey questionnaire

  Assessments will be conducted within 1 week post-training.

• Body mass index (BMI)

  Assessments will be conducted at baseline, within 1 week post-training, and week 8.

• 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.

Study Arms (2)

Video-game group

EXPERIMENTAL

Received the video-game intervention

Device: Video-game

Conventional therapy group

ACTIVE COMPARATOR

Received the conventional therapy intervention

Behavioral: Conventional therapy

Interventions

Video-game DEVICE

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.

Video-game group

Conventional therapy BEHAVIORAL

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.

Conventional therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZHANG Bohan: lead

Study Sites (1)

Beijing Xiaotangshan Hospital

Beijing, China, 100000, China

Location

Related Publications (3)

• Zhang B, Wong KP, Liu M, Hui V, Guo C, Liu Z, Liu Y, Xiao Q, Qin J. Effect of artificial intelligence-based video-game system on dysphagia in patients with stroke: A randomized controlled trial. Clin Nutr. 2025 Feb;45:81-90. doi: 10.1016/j.clnu.2024.12.022. Epub 2024 Dec 25.

  PMID: 39765160 DERIVED

• Zhang B, Wong KP, Liu M, Hui V, Guo C, Liu Y, Liu Z, Liu Y, Xiao Q, Qin J. Face Recognition-Driven Video Game for Dysphagia Rehabilitation in Stroke Patients: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Mar;106(3):342-350. doi: 10.1016/j.apmr.2024.10.005. Epub 2024 Nov 2.

  PMID: 39491573 DERIVED

• Zhang B, Guo C, Hui V, Wong KP, Liu Y, Liu Z, Xu Y, Xiao Q, Chen SC, Qin J. Evaluating the effectiveness of video-game based swallowing function training in patients with dysphagia: study protocol for a randomized controlled trial. Trials. 2023 Nov 16;24(1):735. doi: 10.1186/s13063-023-07738-7.

  PMID: 37974234 DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 7, 2023
• Study Start: October 10, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)