About this trial
This randomized clinical trial aims to evaluate the effectiveness of combining Low Volume Nose Resistance Breathing Exercises (LVNRBE) with Incentive Spirometry (IS) on respiratory outcomes in patients with cervical spinal cord injury (SCI). Respiratory complications are a major concern in cervical SCI due to impaired respiratory muscle function, leading to reduced lung volumes, dyspnea, ineffective cough, and sputum retention. The study will recruit 42 inpatients aged 18-38 years with cervical SCI (C4-C7), randomly divided into two groups: Data Analysis: Statistical tests (paired and independent t-tests) will determine intra- and intergroup differences using SPSS v25, with significance set at p \< 0.05.
* Group A (Intervention): Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks. * Group B (Control): Receives conventional respiratory physiotherapy with the same frequency and duration.
Outcomes will be assessed pre- and post-intervention using:
* Pulmonary Function Tests (FVC, FEV1), * Modified Borg Dyspnea Scale, * Cough Frequency Scale, * Sputum Grading Scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagonosed cervical spine injury C4-C7
Age 18-38 years
Undergoing in-patient rehabilitation
No previous history of severe pulmonary disease
Disqualifiers
Uncontrolled hypertension
Other Neuromuscular disease
Stage 3-4 pressure wound
Clinical instability
Trial design
Parallel
Treatments tested in this trial
Acapella device plus Incentive Spirometry
DevicePFTs will be performed with Spirobank, a handheld digital spirometer, to measure respiratory parameters such as forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV ). These values help assess lung volumes, airflow, and respiratory muscle strength in spinal cord injured patients. They are highly valid and accepted internationally for assessing lung function. Test-retest reliability is strong, with correlation coefficients often exceeding 0.90
conventional respiratory physiotherapy
Behavioralexercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision
Treatment groups
Trial outcomes
Primary outcomes
Pulmonary Function Tests (FVC, FEV1),
PFTs will be performed with Spirobank, a handheld digital spirometer, to measure respiratory parameters such as forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV ). These values help assess lung volumes, airflow, and respiratory muscle strength in spinal cord injured patients. They are highly valid and accepted internationally for assessing lung function. Test-retest reliability is strong, with correlation coefficients often exceeding 0.90.
Modified Borg Dyspnea Scale
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
Secondary outcomes
Cough Frequency Scale
The Cough Frequency Scale (CFS) was used to assess the frequency of coughing episodes in patients with cervical spinal cord injury (SCI). It is a simple, subjective scale that grades cough occurrence based on patient report, typically ranging from no cough (0) to frequent coughing episodes interfering with daily activities.
Sputum Grading Scale.
This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.