Effects of Different Modes of Action Observation Therapy on Swallowing Function After Stroke: a Study Based on fNIRS
1 other identifier
interventional
90
1 country
1
Brief Summary
Dysphagia is one of the most common symptoms of stroke patients, which seriously affects the quality of life of patients and delays the progress of rehabilitation. At present, the commonly used clinical swallowing treatment methods can achieve certain therapeutic effects, but the treatment effect of some patients is still not ideal. Therefore, we need to explore more and more effective treatment methods to improve the swallowing function of patients. Action observation therapy, which was developed based on the mirror neuron theory, has been widely used in the rehabilitation of limb motor function, and its therapeutic effect has been verified by a large number of clinical trials. There are few clinical studies on action observation therapy in swallowing function rehabilitation, and most of the current studies use swallowing videos to allow patients to observe actions, and then guide patients to imitate actions. Some studies have found that oral mirror neurons can be formed in the context of familiar environment, people and emotional communication. Therefore, this study proposes a new mode of action observation therapy for dysphagia, that is, to observe the real swallowing movement in actual daily life, in order to better improve the swallowing function of stroke patients with dysphagia. This study was a single-center, assessor-blinded, randomized controlled study. After enrollment, all patients received swallowing assessment, including scale assessment (WST, FOIS, SSA, BMI, SWAL-QOL, VAS satisfaction survey, KVIQ motor imagery assessment, total oral intake/eating time), neck ultrasound and FNIRS brain function assessment. According to the random number table method, the patients were divided into three groups, A: control group, B: video swallowing movement observation therapy group, C: daily actual swallowing movement observation therapy group. All three groups were given routine swallowing function training. In group B, action observation therapy with video was added, that is, watching a video of swallowing action with sound, and then performing simulated swallowing action. Group C added the actual swallowing movement observation therapy in daily life, that is, in actual daily life, to observe the real eating and swallowing movement of relatives, and then imitate the swallowing movement. The training sessions were 30min each time, once a day, 5 days a week, for a total of 3 weeks. After the treatment, the scale assessment, neck ultrasound and FNIRS brain function assessment were performed again.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jan 2025
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2025
CompletedFirst Submitted
Initial submission to the registry
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 5, 2027
September 22, 2025
July 1, 2025
2 years
July 20, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Oral Intake Scale（FOIS）
This scale is divided into 7 levels in total, which is used to assess the oral feeding ability of the subjects. The higher the level, the better the function. Level 1: Unable to take food orally; Level 2: Dependent on tube feeding, able to attempt very small amounts of food or liquids orally; Level 3: Dependent on tube feeding, able to take food or liquids of a single texture orally; Level 4: Completely able to take food of a single texture orally; Level 5: Completely able to take food of multiple textures orally, but requiring special preparation or compensatory measures; Level 6: Completely able to take food orally without special preparation, but with specific food restrictions; Level 7: Completely able to take food orally without any restrictions.
Assessment before intervention and 3 weeks after intervention after enrollment.
Secondary Outcomes (8)
Body Mass Index（BMI）
Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Through the mouth eating/total time of food intake
Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
The neck ultrasound
Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Score of Water swallow test
Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
functional near - infrared spectroscopy（fNIRS）
Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
- +3 more secondary outcomes
Study Arms (3)
Video swallowing action observation therapy
ACTIVE COMPARATOROn the basis of traditional swallowing training, this group adds video-assisted movement observation therapy, that is, watching swallowing movement videos with sound and then performing simulated swallowing movements.
Daily life actual swallowing action observation therapy
EXPERIMENTALOn the basis of traditional swallowing training, this group adds the practice of observing the real eating and swallowing actions of relatives in actual daily life, and then imitating those swallowing actions.
Traditional swallowing training
ACTIVE COMPARATORRoutine swallowing function training includes indirect training (basic training) and direct training (feeding training). Indirect training includes but is not limited to training for the muscle strength and range of motion of swallowing muscles, training for inducing swallowing reflexes, breathing training, compensatory swallowing training, and airway protection training. Direct training involves the eating environment, body position, food selection, the amount and speed of each mouthful of food, as well as the compensatory skills commonly used during the eating process.
Interventions
This group adds the therapy of observing actual swallowing movements in daily life, that is, in real daily life, observing the real eating and swallowing movements of relatives. They select meals that the patient likes or those that are complete in color, aroma and taste and look appetizing. The swallowing movements should be as slow and exaggerated as possible, and a look of savoring and enjoying the food should be shown, so that the patient can better observe the movements of the mouth and larynx during swallowing. Then, the patient imitates the swallowing movements.
Video swallowing action observation therapy
Traditional swallowing training
Eligibility Criteria
You may qualify if:
- : 1.n accordance with the diagnostic criteria formulated by the Fourth National Academic Conference on Cerebrovascular disease;
- : 2.Dysphagia was detected by water swallowing test;
- : 3.First onset, course of disease within 6 months, the condition is stable;
- : 4.Mini-mental state examination (MMSE) score, literacy \>=17 points, primary education \>=20 points, secondary education \>=24 points, can understand and cooperate with treatment;
- : 5.Have a certain degree of sitting balance ability, can maintain a sitting position for 30 minutes;
- : 6.Aged 18-80 years old;
- : 7.The patient was informed and consented to this study, and the patient's family was informed and trained, and could cooperate with the adjuvant treatment of swallowing movement observation therapy in daily life.
You may not qualify if:
- : Patients with impaired swallowing function due to other reasons;
- : Presence of tumors or other lesions in the mouth or throat;
- : Visual and hearing dysfunction;
- : The presence of agnosia, apraxia or unilateral neglect;
- : Severe cognitive impairment and mental and emotional instability can not cooperate with treatment;
- : Implantation or retention of ferromagnetic metals in the brain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital
Jinan, Shandong, 250000, China
Related Publications (4)
Zhang C, Li X, Wang H. Application of action observation therapy in stroke rehabilitation: A systematic review. Brain Behav. 2023 Aug;13(8):e3157. doi: 10.1002/brb3.3157. Epub 2023 Jul 21.
PMID: 37480161RESULTZeng M, Wang Z, Chen X, Shi M, Zhu M, Ma J, Yao Y, Cui Y, Wu H, Shen J, Xie L, Fu J, Gu X. The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with Dysphagia. Neural Plast. 2023 Apr 21;2023:2382980. doi: 10.1155/2023/2382980. eCollection 2023.
PMID: 37124873RESULTFerrari PF, Gerbella M, Coude G, Rozzi S. Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathways. Neuroscience. 2017 Sep 1;358:300-315. doi: 10.1016/j.neuroscience.2017.06.052. Epub 2017 Jul 4.
PMID: 28687313RESULTJing YH, Lin T, Li WQ, Wu C, Li X, Ding Q, Wu MF, Xu GQ, Lan Y. Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI Study. Front Neurosci. 2020 Aug 21;14:867. doi: 10.3389/fnins.2020.00867. eCollection 2020.
PMID: 32973431RESULT
Related Links
- Application of action observation therapy in stroke rehabilitation: A systematic review
- The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with Dysphagia
- Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathways
- Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI Study
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
July 20, 2025
First Posted
September 22, 2025
Study Start
January 6, 2025
Primary Completion (Estimated)
January 5, 2027
Study Completion (Estimated)
January 5, 2027
Last Updated
September 22, 2025
Record last verified: 2025-07