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

NCT ID: NCT05978700

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deglutition Disorders Rehabilitation Video Game

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Video-game group

Received the video-game intervention

Group Type EXPERIMENTAL

Video-game

Intervention Type 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.

Conventional therapy group

Received the conventional therapy intervention

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZHANG Bohan

OTHER

Sponsor Role lead

Responsible Party

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ZHANG Bohan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Xiaotangshan Hospital

Beijing, China, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39765160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39491573 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37974234 (View on PubMed)

Other Identifiers

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HSEARS20230502007

Identifier Type: -

Identifier Source: org_study_id

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