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The characteristics of oropharyngeal stage in post-stroke dysphagia based on multimodal ultrasonography

The characteristics of oropharyngeal stage in post-stroke dysphagia based on multimodal ultrasonography

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081869
Enrollment
Unknown
Registered
2024-03-14
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-stroke dysphagia

Interventions

Gold Standard:Videofluoroscopic swallowing study and high-resolution manometry
Index test:This study explored the key parameters of ultrasonography to guide the clinical evaluation and treatment of swallowing function. ? B+M ultrasound was used to collect real-time lingual movem

Sponsors

The Eighth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with post-stroke dysphagia: (1) diagnosed as stroke patients by head CT or MRI, which met the diagnostic criteria formulated and passed by the Neurology Branch of the Chinese Medical Association in 2016; (2) Course of disease: 48h-6 months; (3) Age: 20-80 years old; (4) kubota water swallowing test (level 3-5) or FOIS assessment (level 1-4); (5) No serious cognitive dysfunction, can cooperate with examination and treatment; (6) Informed consent (subject to signed informed consent). 2.Patients without dysphagia after stroke: (1) patients diagnosed as stroke by head CT or MR1, which met the diagnostic criteria formulated and passed by the Neurology Branch of the Chinese Medical Association in 2016; (2) Course of disease: 48h-6 months; (3) Age :20-80 years old; (4) Kubota water swallowing test (Level 1); (5) No serious cognitive dysfunction, can cooperate with examination and treatment; (6) Informed consent (subject to signed informed consent). 3.Healthy subjects: (1) Age range 20-80 years old, male to female ratio 1:1; (2) Good physical health; (3) There is no history of swallowing disorders, the function of organs related to swallowing is in good condition, and the swallowing is medically considered normal; (4) no history of head and neck, musculoskeletal, or neurological disorders; (5) cognitively normal, conscious, emotionally stable, able to cooperate with instructions to conduct experiments; (6) After understanding the details of the experiment, voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with or without dysphagia after stroke: (1) unstable vital signs, severe infections, and serious cardiopulmonary diseases; (2) dysphagia caused by anatomical damage or other diseases, such as head and neck radiation therapy or extensive surgery; (3) Severe cognitive impairment, unable to cooperate with instructions; (4) Pregnant or lactating women. Any of the above is excluded. 2.Healthy subjects: (1) have any swallowing/breathing discomfort or confirmed dysfunction; (2) There is any structural change in the head and neck; (3) any neurological or mental illness; (4) serious heart, lung, kidney and other organ diseases; (5) cognitive dysfunction, audio-visual impairment, unable to cooperate with operational instructions; (6) Refuse to sign the informed consent. Any of the above is excluded.

Design outcomes

Primary

MeasureTime frame
Degree of upper esophageal sphincter opening;Correlation between ultrasound and VFSS and HRM;Area under ROC curve;

Secondary

MeasureTime frame
upper esophageal sphincter opening time;upper esophageal sphincter closure time;duration of upper esophageal sphincter displacement;amplitude of lateral pharyngeal wall displacement;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactShaofeng Zhao

The Eighth Affiliated Hospital of Sun Yat-sen University

zhaoshf6@mail.sysu.edu.cn+86 188 9977 3005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026