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The Effectiveness of Intraoral Balloon Dilation Combined with K-Point Stimulation in Patients with Stroke-Associated Trismus and Dysphagia: A Randomized Controlled Trial

The Effectiveness of Intraoral Balloon Dilation Combined with K-Point Stimulation in Patients with Stroke-Associated Trismus and Dysphagia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084618
Enrollment
Unknown
Registered
2024-05-21
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Stroke-Associated Trismus and Dysphagia

Interventions

observation group:intraoral balloon dilation combined with K-point stimulation treatment
control group :K-point stimulation treatment alone

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Stroke diagnosis according to the Chinese Stroke Prevention and Treatment Guidelines (2021 Edition); (2) Diagnosis of pseudobulbar palsy based on radiological and neurological findings, with accompanying trismus and dysphagia; (3) Glasgow Coma Scale (GCS) score of =8; (4) Stable vital signs; (5) Age between 18-70 years; (6) Informed consent signed by a family member on behalf of the patient

Exclusion criteria

Exclusion criteria: (1) Patients on dual antiplatelet therapy with a predisposition to oral mucosal bleeding; (2) History of recurrent oral ulcers; (3) Long-term use of sedatives and angiotensin-converting enzyme (ACE) inhibitors; (4) Endotracheal intubation; (5) Temporomandibular joint (TMJ) dysfunction

Design outcomes

Primary

MeasureTime frame
effective mouth opening times;degree of mouth opening;effective swallowing times;

Secondary

MeasureTime frame
the 2-minute frequency of spontaneous swallowing;the positive rate of the simple swallowing provocation test (SSPT);

Countries

China

Contacts

Public ContactHu Naixiao

China Rehabilitation Research Center

2784211998@qq.com+86 158 2237 6890

Outcome results

None listed

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