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Observation of the effect of botulinum toxin type A combined with rehabilitation training on salivation in post-stroke tracheotomy patients

Observation of the effect of botulinum toxin type A combined with rehabilitation training on salivation in post-stroke tracheotomy patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094596
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

dysphagia

Interventions

Swallowing training group:Swallowing training: Swallowing training includes basic training (pronunciation exercise training, cheek and throat training, tongue muscle training, ice stimulation), airway
100U injection group:100U salivary gland botulinum toxin injection combined with swallowing training therapy
200U injection group:200U salivary gland botulinum toxin injection combined with swallowing training therapy

Sponsors

Hebei Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: Select 120 patients with ischemic stroke who underwent tracheotomy in the neurology and rehabilitation medicine departments of Hebei Provincial People's Hospital First time. 1. stroke patients who meet the diagnostic criteria for ischemic stroke, aged 30-75 years, with a course of disease within 2 weeks to 6 months; 2.Patients undergoing tracheotomy; 3. Patients with swallowing disorders identified through Flexible Endoscopic Examination of Swallowing (FEES); 4. FEES endoscopic Murray secretion severity score >= 2 points; 5. Accompanied by salivation; 6. Voluntarily participate in this observation experiment, with approval and consent from the ethics committee, and sign the patient informed consent form ; 7.No obvious swallowing difficulties before onset.

Exclusion criteria

Exclusion criteria: 1. Patients with severe underlying diseases such as heart, liver, and kidney, as well as those with mental illnesses; 2. Having consciousness disorders, obvious cognitive and behavioral disorders, aphasia, etc., unable to cooperate in completing examinations and treatments; 3. Allergic to botulinum toxin type A; 4. The condition is unstable, accompanied by severe liver, kidney, and blood diseases, as well as gastroesophageal reflux disease, including fever, throat, and lung infections

Design outcomes

Primary

MeasureTime frame
Drooling severity and frequency scales (DSFS);Murray Secretion Severity Scale;Wearing time of balloon tracheostomy tube;Unstimulated saliva flow rate (uSFR) ;

Secondary

MeasureTime frame
clinical pulmonary infection score,CPIS;

Countries

China

Contacts

Public ContactWang Xiaohan

Hebei Provincial People's Hospital

1209339500@qq.com+86 186 3018 9380

Outcome results

None listed

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