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NCT07184892Recruiting

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

Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
20 Jul 2025
Start date
6 Jan 2025
Primary completion date
5 Jan 2027
Lead sponsor
Qilu Hospital of Shandong University
Diseases
Stroke
NCT number
NCT07184892

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 6 Jan 2025 to the primary completion date, 5 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qilu Hospital
Coordinator of this site? Confirm its status
JinanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.