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The Effect of Combined External Diaphragm Pacing and Progressive Resistance Inspiratory Muscle Training on Pulmonary Function in Stroke Patients

Efficacy and Underlying Mechanisms of Integrated External Diaphragm Pacing and Progressive Inspiratory Muscle Resistance Training on Respiratory Function in Stroke Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114025
Enrollment
Unknown
Registered
2025-12-05
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Stroke

Interventions

Control group:Standard Rehabilitation Therapy
IMT group:Standard Rehabilitation Therapy+Progressive Resistance Training for Inspiratory Muscles
Combined intervention group:Standard Rehabilitation Therapy+Progressive Resistance Training for Inspiratory Muscles+External Diaphragm Pacing

Sponsors

The Fourth Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of acute ischemic stroke confirmed by cranial MRI, consistent with the criteria outlined in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018; 2. First-ever stroke episode within 3 months prior to enrollment, with stable vital signs (e.g., blood pressure, respiration, pulse); 3. Conscious with adequate comprehension and compliance, capable of cooperating with the treatment procedures; 4. Pulmonary function below 80% of the predicted normal value, as verified by spirometry.

Exclusion criteria

Exclusion criteria: 1. Patients with comorbid conditions such as myasthenia gravis, phrenic nerve paralysis, or severe dysfunction/failure of major organs (e.g., heart, kidney, liver); 2. Presence of an implantable cardiac pacemaker or other electronic medical devices; 3. Severe cognitive impairment or comprehension deficits that preclude compliance with the study protocol; 4.History of chronic or significant pulmonary, thoracic, or abdominal diseases.

Design outcomes

Primary

MeasureTime frame
Forced Vital Capacity (FVC);Percentage of forced expiratory volume in one second relative to predicted value (FEV1%);Forced expiratory volume in one second/forced vital capacity (FEV1/FVC);Peak expiratory flow (PEF);Maximal voluntary ventilation (MVV);Maximum Inspiratory Pressure (MIP);Maximum Expiratory Pressure (MEP);Diaphragmatic ultrasound assessment;—

Secondary

MeasureTime frame
Basel Index;Respiratory complications;Diaphragm motor-evoked potentials;—

Countries

China

Contacts

Public ContactMin Su

The Fourth Affiliated Hospital of Soochow University

sumin@suda.edu.cn+86 177 1266 1015

Outcome results

None listed

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