Deglutition DisordersNCT05978700
Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia
A study testing Video-game and Conventional therapy in people with Deglutition Disorders and Rehabilitation, run by ZHANG Bohan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Rehabilitation, Video Game
- What is being tested?
- Video-game and Conventional therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Deglutition Disorders, Rehabilitation, Video Game
- Being tested
- Video-game, Conventional therapy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-gameDevice
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-game group | Experimental | Received the video-game intervention Receives: Device: Video-game |
| Conventional therapy group | Active comparator | Received the conventional therapy intervention Receives: Behavioral: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessments were conducted at baseline, within 1 week post-training, and week 8.
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessments will be conducted at baseline, within 1 week post-training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start10 Oct 2023
- Primary completion1 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZHANG Bohan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZHANG Bohan, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978700
- Sponsor's protocol ID
- HSEARS20230502007
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only PI and CI can use IPD.
Publications
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.
PubMed 39765160Zhang 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.
PubMed 39491573Zhang 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.
PubMed 37974234
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05978700
- Acronym / sponsor ID
- HSEARS20230502007
- Conditions
- Deglutition Disorders, Rehabilitation, Video Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ZHANG BohanUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-game group | Experimental | Device: Video-gameReceived the video-game intervention |
| Conventional therapy group | Active comparator | Behavioral: Conventional therapyReceived the conventional therapy intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-gameThe 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. | Device | Video-game group |
| Conventional therapyThe 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. | Behavioural | Conventional therapy group |
Primary outcome
the Toronto Bedside Swallowing Screening Test (TOR-BSST)
Time frame: 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.
the Functional Oral Intake Scale (FOIS)
Time frame: 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.
8 secondary outcomes
The swallowing quality of life (SWAL-QOL) questionnaire
Time frame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
The acceptance survey questionnaire
Time frame: Assessments will be conducted within 1 week post-training.
Body mass index (BMI)
Time frame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
Mini Nutritional Assessment Short Form (MNA-SF)
Time frame: Assessments will be conducted at baseline, within 1 week post-training, and week 8.
The satisfaction questionnaire
Time frame: Assessments will be conducted within 1 week post-training.
Adherence
Time frame: Assessments will be within 1 week post-training.
Self-efficacy
Time frame: Assessments will be conducted at baseline, within 1 week post-training.
Learned helplessness
Time frame: Assessments will be conducted at baseline, within 1 week post-training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 39765160Zhang 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.
- Derived from this study: PubMed 39491573Zhang 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.
- Derived from this study: PubMed 37974234Zhang 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.
- Individual participant dataSharing planned: No. Only PI and CI can use IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-game and Conventional therapy in people with Deglutition Disorders and Rehabilitation, run by ZHANG Bohan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Toronto Bedside Swallowing Screening Test (TOR-BSST) (time frame: Assessments were conducted at baseline, within 1 week post-training, and week 8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05978700, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.