Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShengjing Hospital
About this trial
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:
* The impact of threshold pressure load respiratory muscle training on the respiratory function of SCI patients. * The impact of iTBS treatment at the cortical projection point of the diaphragm on the respiratory function of SCI patients. * Whether the combination of the above two treatment techniques is superior to single treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with spinal cord injury (SCI) meeting the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury by the American Spinal Injury Association (ASIA), confirmed by CT/MRI.
Aged 18-80 years.
Time since injury: 2 weeks to 6 months, with spinal shock resolved.
Injury level at T12 or above, ASIA Impairment Scale (AIS) grade A-C.
Disqualifiers
Patients with severe cardiorespiratory diseases (e.g., pneumothorax).
Unstable vital signs (e.g., hypotension, arrhythmia).
Cognitive/psychiatric disorders precluding cooperation.
Requiring mechanical ventilation.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
DeviceParticipants received group-specific interventions 5 days/week for 4 weeks.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group A: sham stimulation + threshold pressure-loaded respiratory muscle trainingExperimental treatment 1 intervention
Group B: Group B: iTBS + traditional respiratory trainingExperimental treatment 1 intervention
Group C: Group C: iTBS + threshold pressure-loaded respiratory muscle trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximal Inspiratory Pressure
the maximum negative pressure generated in the respiratory system during a maximal inhalation against a closed airway, measured in cmH₂O to assess inspiratory muscle strength.
Time frame
Week 0 , Week 2 , Week 42
Maximal Expiratory Pressure
the maximum positive pressure generated in the respiratory system during a maximal exhalation against a closed airway, measured in cmH₂O to assess expiratory muscle strength.
Time frame
Week 0 , Week 2 , Week 43
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.
Time frame
Week 0 , Week 2 , Week 44
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.
Time frame
Week 0 , Week 2 , Week 4Secondary outcomes
1
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.
Time frame
Week 0 , Week 2 , Week 42
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).
Time frame
Week 0 , Week 2 , Week 43
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.
Time frame
Week 0 , Week 2 , Week 4Other outcomes
1
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.
Time frame
Week 0 , Week 2 , Week 42
Maximum Vowel Prolongation Time
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
Time frame
Week 0 , Week 2 , Week 43
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.
Time frame
Week 0 , Week 2 , Week 44
Motor Function
Trunk Control Test,Modified Barthel Index
Time frame
Week 0 , Week 2 , Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov