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

Overview

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.

Interventions

• Behavioral 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 lar
• Behavioral Video swallowing action observation therapy
  Video swallowing action observation therapy
• Behavioral Traditional swallowing training
  Traditional swallowing training

Primary outcome measures

• Functional Oral Intake Scale（FOIS） [Time frame: Assessment before intervention and 3 weeks after intervention after enrollment.]

Secondary outcome measures (8)

• Body Mass Index（BMI） [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• Through the mouth eating/total time of food intake [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• The neck ultrasound [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• Score of Water swallow test [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• functional near - infrared spectroscopy（fNIRS） [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• Kinesthetic and Visual Imagery Questionnaire（KVIQ) score [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• Visual analogue scale（VAS）satisfaction survey score [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]
• swallowing-quality of life（SWAL-QOL）scale score [Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital — Jinan

Publications

• 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 37480161
• 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. PMID 37124873
• 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. PMID 28687313
• 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. PMID 32973431

Identifiers

NCT: NCT07184892 · KYLL-202406-003-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗