Protocol for an RCT testing video-game based swallowing training for post-stroke dysphagia
How this was rated
Protocol paper only - no results. Certainty cannot be assessed until the trial is completed and results published.
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This paper describes the protocol for a planned randomized controlled trial that will test whether a video-game based swallowing training program driven by surface electromyography (sEMG) biofeedback is more effective than conventional swallowing training for adults with post-stroke dysphagia. No results are available yet - this is the study design and methodology plan, registered on ClinicalTrials.gov as NCT05978700.
A published protocol for a planned RCT in post-stroke dysphagia. Results are not yet available. The study design is sound; await the results paper before drawing clinical conclusions.
Key findings
- Planned RCT to enroll 78 patients aged 18-80 with post-stroke dysphagia across two sites in Beijing, China.
- Experimental group: video-game based swallowing function training using sEMG-driven game biofeedback.
- Control group: conventional swallowing function training.
- Both groups: 30 minutes per day, 5 days per week, for 4 weeks.
- Primary outcome: swallowing function. Secondary outcomes: quality of life, training compliance, and training satisfaction.
- Assessments planned at baseline, 4-week post-treatment, and 8-week follow-up with blinded outcome assessment.
Background
Dysphagia - difficulty swallowing - is a common consequence of stroke and can significantly affect nutrition, hydration, and quality of life. Supporting swallowing recovery typically involves intensive, repetitive practice, which can be monotonous and difficult to sustain. Surface electromyography (sEMG) biofeedback provides visual feedback on muscle activity during swallowing, but the displays are often clinical and unengaging. Game-based approaches offer a way to transform biofeedback into an interactive experience that may increase motivation and practice intensity.
Zhang and colleagues at Hong Kong Polytechnic University, in collaboration with rehabilitation centers in Beijing, designed a randomized controlled trial to test this hypothesis rigorously. This paper describes the protocol - the plan - for that trial. No results are yet available.
What the researchers planned to do
The trial will recruit 78 adults aged 18-80 who have developed dysphagia following stroke, across two sites in Beijing, China (Tiantan Xiaotangshan Rehabilitation Center and a second collaborating center). Participants will be randomly assigned to one of two groups.
The experimental group will receive video-game based swallowing training: sEMG sensors placed on the throat capture muscle activity during swallowing, which drives interactive game visuals. Successful swallowing movements control game elements, turning each swallow into a meaningful in-game action.
The control group will receive conventional swallowing function training with standard clinical approaches.
Both groups will complete 30-minute sessions, 5 days per week, for 4 weeks. Outcome assessors will be blinded to group allocation.
What outcomes will be measured
The primary outcome is swallowing function, assessed by standardized clinical measures. Secondary outcomes include quality of life, training compliance (how consistently participants complete sessions), and training satisfaction (how participants experience the intervention).
Assessments are planned at three time points: baseline (before treatment), 4 weeks post-treatment, and an 8-week follow-up to assess whether any gains are maintained.
Why this matters
The rationale for this trial is sound: if game-based biofeedback increases practice intensity and motivation, it could improve outcomes over conventional training. The trial is registered and the protocol is published, which increases transparency and allows for later comparison with results. When completed, this study will provide important controlled evidence about gamified swallowing rehabilitation after stroke.
Limitations
This is a protocol paper only - no results are reported. The trial is currently ongoing or awaiting results. The study is conducted at rehabilitation centers in Beijing, China, which may limit generalizability to other healthcare systems. The planned sample of 78 participants is modest for an RCT and may have limited statistical power for detecting small effects.
Implications for practice
This protocol describes a well-designed RCT that, when completed, will provide important evidence about whether game-based biofeedback improves swallowing outcomes after stroke compared to conventional training. Clinicians interested in gamified swallowing rehabilitation should monitor this trial for results. No practice changes are warranted on the basis of the protocol alone.
Where this connects to Therapy withVR
The study above is independent research and does not endorse any product. The notes below are commentary from withVR on how the themes in this research relate to features of Therapy withVR. The research findings are not claims about Therapy withVR.
Engaging VR Environments
This protocol proposes that gamification increases practice motivation - Therapy withVR's immersive environments can complement biofeedback approaches by providing engaging visual contexts that sustain the intensive practice needed for functional improvement in swallowing rehabilitation.
Cite this study
If you reference this study in your work, the canonical citation formats are:
@article{zhang2023,
author = {Zhang, B. and Guo, C. and Hui, V. and Wong, K. P. and Liu, Y. and Liu, Z. and Xu, Y. and Xiao, Q. and Chen, S. C. and Qin, J.},
title = {Evaluating the effectiveness of video-game based swallowing function training in patients with dysphagia: study protocol for a randomized controlled trial},
journal = {Trials},
year = {2023},
doi = {10.1186/s13063-023-07738-7},
url = {https://withvr.app/evidence/studies/zhang-2023}
}TY - JOUR
AU - Zhang, B.
AU - Guo, C.
AU - Hui, V.
AU - Wong, K. P.
AU - Liu, Y.
AU - Liu, Z.
AU - Xu, Y.
AU - Xiao, Q.
AU - Chen, S. C.
AU - Qin, J.
TI - Evaluating the effectiveness of video-game based swallowing function training in patients with dysphagia: study protocol for a randomized controlled trial
JO - Trials
PY - 2023
DO - 10.1186/s13063-023-07738-7
UR - https://withvr.app/evidence/studies/zhang-2023
ER - Know of research that should be in this hub? If a relevant peer-reviewed study is not listed here, send the reference to hello@withvr.app. The hub is kept up to date as the literature grows.
Funding & independence
The authors state: 'This research will apply for funding in the future, and there is no funding to support at this time.' Institutions: Hong Kong Polytechnic University (Smart Health, School of Nursing), Tiantan Xiaotangshan Rehabilitation Center Beijing, and Hanshan Normal University. Trial registration: ClinicalTrials.gov NCT05978700 (registered 28 July 2023). No withVR BV involvement in funding, study design, or authorship. Summary prepared independently by withVR using the published paper.