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The purpose of this clinical trial is to understand whether threshold pressure load respiratory muscle training combined with iTBS can effectively improve the respiratory function of SCI patients. The main questions it aims to answer are:
Researchers will combine threshold pressure load respiratory muscle training and transcranial iTBS and compare them with single treatments to see if the combined treatment is superior to single treatment.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: sham stimulation + threshold pressure-loaded respiratory muscle training | Experimental | Sham Stimulation "8" coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT intensity. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Coil at 90° to scalp to avoid cortical current. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. |
|
| Group B: iTBS + traditional respiratory training | Experimental | iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Traditional Respiratory Training 5 therapist-led maneuvers: Pursed-lip: inhale (3-4s) via nose, pause (1-2s), exhale (5-6s) with pursed lips (6-8 br/min), 20 br/set. Diaphragmatic: seated/supine, hands over umbilicus. Inhale to expand abdomen (3-5s), exhale to compress (6-8s). 4-6 br/min, 20 br/set. Forced exhale: inhale (3-5s), forcefully exhale "ha" (2-3s), 4-6 br/min, 20 br/set. Resisted inhale: supine, 1kg sandbag on umbilicus. Diaphragmatic breathing (4-6 br/min), 20 br/set. 3 sets/d, 5d/wk × 4wk. |
|
| Group C: iTBS + threshold pressure-loaded respiratory muscle training | Experimental | iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device | Device | Participants received group-specific interventions 5 days/week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Inspiratory Pressure | the maximum negative pressure generated in the respiratory system during a maximal inhalation against a closed airway, measured in cmHâ‚‚O to assess inspiratory muscle strength. | Week 0 , Week 2 , Week 4 |
| Maximal Expiratory Pressure | the maximum positive pressure generated in the respiratory system during a maximal exhalation against a closed airway, measured in cmHâ‚‚O to assess expiratory muscle strength. | Week 0 , Week 2 , Week 4 |
| Peak Expiratory Flow | the maximum speed of air flow during a forced exhalation, measured in liters per minute (L/min) to assess airway patency and respiratory function. | Week 0 , Week 2 , Week 4 |
| Peak Inspiratory Flow | the maximum speed of air flow during a forced inhalation, measured in liters per minute (L/min) to evaluate inspiratory muscle function and airway resistance during inhalation. | Week 0 , Week 2 , Week 4 |
| Forced Expiratory Volume in 1 second | the volume of air exhaled forcefully within the first second of a maximal expiratory effort, measured in liters to assess airway obstruction and lung function. | Week 0 , Week 2 , Week 4 |
| Forced Vital Capacity | the total volume of air exhaled forcefully and completely after a maximal inhalation, measured in liters to evaluate lung function and airway patency. | Week 0 , Week 2 , Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic Thickness | Position patient supine with arms up. Place convex probe at mid-axillary line (7th-9th intercostal space), parasagittal plane. Identify diaphragmatic muscle between pleural and peritoneal interfaces, 2-3 cm from central tendon. Measure thickness at end-expiration and end-inspiration (3 trials each). Calculate DTF to assess diaphragmatic function. | Week 0 , Week 2 , Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 4th Intercostal Space Thoracic Mobility | At the 4th intercostal space along the midclavicular or anterior axillary line, thoracic mobility is measured by the difference in circumferences between maximal exhalation and inhalation using a non-stretch tape. | Week 0 , Week 2 , Week 4 |
| Maximum Vowel Prolongation Time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Xue | Contact | +86 18940254064 | jiangxueruby@163.com | |
| Zhang Di | Contact | +86 15291000208 | zhangdi6952@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Xue | Rehabilitation Center of Shengjing Hospital, China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Center of Shengjing Hospital, China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Group A: sham stimulation + threshold pressure-loaded respiratory muscle training; Group B: iTBS + traditional respiratory training; Group C: iTBS + threshold pressure-loaded respiratory muscle training.
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| Diaphragmatic Displacement | Position patient supine/semi-recumbent, expose lower chest. Place convex probe at mid-axillary line (8th-10th intercostal space), sagittal plane. Visualize diaphragmatic-liver interface (right hemidiaphragm preferred). Use M-mode to record diaphragmatic movement over respiratory cycles. Measure vertical distance between end-expiration and end-inspiration positions (normal >1.5 cm for weaning). | Week 0 , Week 2 , Week 4 |
| Diaphragmatic Thickening Fraction | Measure Thickness at End-Expiration: Using ultrasound, measure the diaphragm thickness at the end of a quiet exhalation (when the diaphragm is relaxed). Measure Thickness at End-Inspiration: Measure the thickness at the end of a maximal inhalation (when the diaphragm is fully contracted). Calculate the Difference: Subtract the end-expiration thickness from the end-inspiration thickness. Normalize by End-Expiration Thickness: Divide the difference by the end-expiration thickness, then multiply by 100 to get a percentage. | Week 0 , Week 2 , Week 4 |
Maximum vowel prolongation time is obtained by measuring the duration of sustained /a:/ phonation from maximal inspiration to complete expiration, with the subject seated upright and maintaining consistent pitch and loudness |
| Week 0 , Week 2 , Week 4 |
| The incidence of pneumonia during hospitalization for each patient group | The incidence of pneumonia during hospitalization for each patient group is calculated as the number of newly diagnosed pneumonia cases divided by the total number of patients in the group, typically expressed per 100 patient-days or as a percentage. | Week 0 , Week 2 , Week 4 |
| Motor Function | Trunk Control Test,Modified Barthel Index | Week 0 , Week 2 , Week 4 |
| Hemodynamic Changes " BP " During Supine-to-Sitting Transfer | Measure baseline supine BP after 10-min rest. | Week 0 , Week 2 , Week 4 |
| Hemodynamic Changes "HR" During Supine-to-Sitting Transfer | Measure baseline supine HR after 10-min rest. | Week 0 , Week 2 , Week 4 |
| D014947 | Wounds and Injuries |