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Combining Extracorporeal Diaphragm Pacing Therapy with Swallowing Rehabilitation for the Management of Post-stroke Dysphagia

Clinical Application of Extracorporeal Diaphragm Pacing Combined with Swallowing Training in Post-Stroke Dysphagia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115354
Enrollment
Unknown
Registered
2025-12-25
Start date
2021-08-30
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Post-Stroke Dysphagia

Interventions

The conventional group:Patients received conventional swallowing rehabilitation therapy. Therapists provided swallowing training, guiding patients to perform daily empty swallows, as well as exercises
Trial group:On the basis of conventional swallowing rehabilitation therapy, an external diaphragmatic pacemaker was used. Patients were placed in a supine position without a pillow, with the head in m
small electrode pads were applied at the lower one-third of the outer border of both sternocleidomastoid muscles. After returning the head to midline, large electrode pads were applied along the midcl
the initial stimulation rate was set at 9 times per minute with an intensity of 20 units, and the intensity was gradually increased from low to high within the patient’s tolerance range to achieve opt

Sponsors

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. diagnosis of stroke by Magnetic Resonance Imaging or Computerized Tomography scans; 2. a score of 3 or higher on the Penetration-Aspiration Scale; 3. within one year of acute stroke diagnosis; 4. Mini-Mental State Examination score >= 20 (Katzman et al., 1988); 5. over the age of 18-80; 6. adequate cognitive-communicative function to provide informed consent and respond to simple verbal commands.

Exclusion criteria

Exclusion criteria: 1. Those with severe dysfunction of organs such as the heart, liver and kidneys, and unstable vital signs; 2. Loss of consciousness or lack of cooperative ability; 3. Esophageal reflux, esophageal diverticulum and other gastrointestinal diseases and dysphagia caused by other reasons.

Design outcomes

Primary

MeasureTime frame
The standardized 8-item penetration aspiration scale;Incidence of Aspiration Pneumonia;Length of Hospital Stay;

Secondary

MeasureTime frame
Standardized swallowing assessment (SSA);Laryngoscopic Swallowing Assessment Scale;Swallowing Quality of Life Scale (SWAL-QOL) Score;Fujishima Water Swallowing Test Score;

Countries

China

Contacts

Public ContactYang Heliang

Jinhua Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

yheliang18@163.com+86 135 1693 0948

Outcome results

None listed

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