Effects of Different Modes of Action Observation Therapy on Swallowing Function After Stroke: a Study Based on fNIRS

NCT ID: NCT07184892

Last Updated: 2025-09-22

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2027-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

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 swallowing action observation therapy

On 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.

Group Type ACTIVE_COMPARATOR

Video swallowing action observation therapy

Intervention Type BEHAVIORAL

Video swallowing action observation therapy

Daily life actual swallowing action observation therapy

On 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.

Group Type EXPERIMENTAL

Daily life actual swallowing movement observation therapy

Intervention Type BEHAVIORAL

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.

Traditional swallowing training

Routine 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.

Group Type ACTIVE_COMPARATOR

Traditional swallowing training

Intervention Type BEHAVIORAL

Traditional swallowing training

Interventions

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Daily life actual swallowing movement observation therapy

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.

Intervention Type BEHAVIORAL

Video swallowing action observation therapy

Video swallowing action observation therapy

Intervention Type BEHAVIORAL

Traditional swallowing training

Traditional swallowing training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1: 1.n accordance with the diagnostic criteria formulated by the Fourth National Academic Conference on Cerebrovascular disease;

2: 2.Dysphagia was detected by water swallowing test;

3: 3.First onset, course of disease within 6 months, the condition is stable;

4: 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: 5.Have a certain degree of sitting balance ability, can maintain a sitting position for 30 minutes;

6: 6.Aged 18-80 years old;

7: 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.

Exclusion Criteria

* 1: Patients with impaired swallowing function due to other reasons;

2: Presence of tumors or other lesions in the mouth or throat;

3: Visual and hearing dysfunction;

4: The presence of agnosia, apraxia or unilateral neglect;

5: Severe cognitive impairment and mental and emotional instability can not cooperate with treatment;

6: Implantation or retention of ferromagnetic metals in the brain.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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艳平 Yanping Ma

Role: CONTACT

86-18560083615

Yonghui Wang

Role: CONTACT

86-18560083581

Facility Contacts

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Yanping Ma

Role: primary

86-18560083615

Yonghui Wang

Role: backup

86-18560083581

References

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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.

Reference Type RESULT
PMID: 37480161 (View on PubMed)

Zeng 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.

Reference Type RESULT
PMID: 37124873 (View on PubMed)

Ferrari 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.

Reference Type RESULT
PMID: 28687313 (View on PubMed)

Jing 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.

Reference Type RESULT
PMID: 32973431 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/37480161/

Application of action observation therapy in stroke rehabilitation: A systematic review

https://pubmed.ncbi.nlm.nih.gov/37124873/

The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with Dysphagia

https://pubmed.ncbi.nlm.nih.gov/28687313/

Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathways

https://pubmed.ncbi.nlm.nih.gov/32973431/

Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI Study

Other Identifiers

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KYLL-202406-003-1

Identifier Type: -

Identifier Source: org_study_id

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