Early respiratory therapy and rehabilitation interventions in the role of the prognosis of patients with acute traumatic spinal cord injury

Early aggressive respiratory therapy and rehabilitation interventions in the role of the prognosis of patients with acute traumatic spinal cord injury and explore oxidative stress, inflammation, DNA damage, leukocyte apoptosis and endothelial dysfunction, and its association with cardiovagal function and cerebral autoregulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16066516

Enrollment

Registered

2017-10-10

Start date

2015-04-21

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Acute spinal cord injury Injury, Occupational Diseases, Poisoning Injury of spinal cord, level unspecified

Interventions

Rehabilitation treatment: Patients participated in a 12-week exercise program. They performed mobility, strength, range of motion, aerobic resistance, and ambulation training. A minimum exercise frequ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute Spinal Cord Injury (SCI) patients aged 20-70 years old 2. Patients will be enrolled in this study only if full informed written consent is obtained from the patient or their families and they qualify for the above-mentioned diagnostic criteria. The informed written consent will be approved by the Ethics Committee

Exclusion criteria

Exclusion criteria: 1. Severe multiple trauma with unstable hemodynamic status 2. Previous brain insults, such as stroke, traumatic intracranial hemorrhage, meningitis, or degenerative brain diseases that cause central nerve system abnormality 3. Infection or inflammation status before admission 4. Diffuse atherosclerotic changes on extracranial vessels; hematologic disorders that affect leukocyte, platelet count, or function 5. Taking antiplatelet or anticoagulation drugs 6. Major systemic disease, such as end-stage renal diseases, liver cirrhosis, and congestive heart failure

Design outcomes

Primary

Measure	Time frame
Measured at baseline, 2 weeks, 1 month, 3 months and 6 months: 1. Mechanical ventilation free rate (no mechanical ventilator used) at discharge 2. Respiratory function: 2.1. Maximal inspiratory pressure (MIP) measured with a pressure manometer 2.2. Maximal expiratory pressure (MEP) measured with a pressure manometer 2.3. Rapid shallow breathing index (RSBI, respiratory rate/tidal volume) measured using Haloscale 3. Muscle power of limbs, measured using Japanese Orthopaedic Association (JOA) cervical spine myelopathy functional assessment score	—

Measure

Time frame

Measured at baseline, 2 weeks, 1 month, 3 months and 6 months: 1. Mechanical ventilation free rate (no mechanical ventilator used) at discharge 2. Respiratory function: 2.1. Maximal inspiratory pressure (MIP) measured with a pressure manometer 2.2. Maximal expiratory pressure (MEP) measured with a pressure manometer 2.3. Rapid shallow breathing index (RSBI, respiratory rate/tidal volume) measured using Haloscale 3. Muscle power of limbs, measured using Japanese Orthopaedic Association (JOA) cervical spine myelopathy functional assessment score

—

Secondary

Measure	Time frame
Measured at baseline, 2 weeks, 1 month, 3 months and 6 months: 1. Endothelial oxidative stress, measured using ELISA 2. DNA damage, measured using RT-PCR 3. Inflammation, measured using ELISA 4. Leukocyte apoptosis, measured using a flow cytometic assay 5. Circulating endothelial progenitor cells (EPCs), measured using a flow cytometric method 6. Baroreflex sensitivity, measured using Valsalva maneuver and sequence method 7. Cerebral autoregulation, measured using Arterial Spin Labeling (ASL) MRI	—

Measure

Time frame

Measured at baseline, 2 weeks, 1 month, 3 months and 6 months: 1. Endothelial oxidative stress, measured using ELISA 2. DNA damage, measured using RT-PCR 3. Inflammation, measured using ELISA 4. Leukocyte apoptosis, measured using a flow cytometic assay 5. Circulating endothelial progenitor cells (EPCs), measured using a flow cytometric method 6. Baroreflex sensitivity, measured using Valsalva maneuver and sequence method 7. Cerebral autoregulation, measured using Arterial Spin Labeling (ASL) MRI

—

Countries

Taiwan

Outcome results

None listed

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