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

S

Shandong University

Status

Enrolling

Conditions

Stroke

Treatments

Behavioral: Video swallowing action observation therapy
Behavioral: Daily life actual swallowing movement observation therapy
Behavioral: Traditional swallowing training

Study type

Interventional

Funder types

Other

Identifiers

NCT07184892
KYLL-202406-003-1

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Video swallowing action observation therapy
Active Comparator group
Description:
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.
Treatment:
Behavioral: Video swallowing action observation therapy
Daily life actual swallowing action observation therapy
Experimental group
Description:
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.
Treatment:
Behavioral: Daily life actual swallowing movement observation therapy
Traditional swallowing training
Active Comparator group
Description:
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.
Treatment:
Behavioral: Traditional swallowing training

Trial contacts and locations

1

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Central trial contact

Yonghui Wang; 艳平 Yanping Ma

Data sourced from clinicaltrials.gov

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