Cervical Spinal Cord InjuryNCT07645027
Low Volume Nose Resistance Breathing Exercise With Incentive Spirometer in Patient With Cervical Spinal Cord Injuries
A study testing Acapella device plus Incentive Spirometry and conventional respiratory physiotherapy in people with Cervical Spinal Cord Injury and Cervical Cord Injuries Spinal, run by Riphah International University at 1 site in Pakistan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Cervical Spinal Cord Injury, Cervical Cord Injuries Spinal
- What is being tested?
- Acapella device plus Incentive Spirometry and conventional respiratory physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagonosed cervical spine injury C4-C7
- Age 18-38 years
- Undergoing in-patient rehabilitation
- No previous history of severe pulmonary disease
- Disease duration <1 year
- Ability to give informed consent
- Road Accident
Who cannot join
- Uncontrolled hypertension
- Other Neuromuscular disease
- Stage 3-4 pressure wound
- Clinical instability
- Traumatic Brain injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah hoapital
Lahore, Punjab Province, 40100
Misdaq Batool, MS PT, 03466584498, misdaaqbatool@yahoo.com.ph
Haney Arif, MS PT, 03334572500, Haneyarif67@gmail.com
About this study
Official title: Effect of Low Volume Nose Resistance Breathing Exercise With Incentive Spirometer on Pulmonary Function Test, Dyspnea, Cough and Sputum in Patient With Cervical Spinal Cord Injuries
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.
Read more
Outcomes will be assessed pre- and post-intervention using:
- Pulmonary Function Tests (FVC, FEV1),
- Modified Borg Dyspnea Scale,
- Cough Frequency Scale,
- Sputum Grading Scale.
Read the detailed description
Spinal cord injuries (SCI), particularly at the cervical level, often lead to compromised respiratory function due to partial or complete paralysis of respiratory muscles. This impairment significantly affects pulmonary function, increases dyspnea, and reduces overall quality of life. Respiratory complications remain one of the leading causes of morbidity in individuals with cervical SCI.
Various therapeutic approaches, including breathing exercises and assistive devices, have been used to enhance pulmonary rehabilitation. Pulmonary rehabilitation strategies, including breathing exercises and incentive spirometry, are essential in improving respiratory function in this population.
These techniques help enhance lung expansion, improve airway clearance, and reduce the risk of pulmonary complications, thereby supporting better respiratory health and functional outcomes The primary objective of this study is to evaluate the effect of LVNRBE combined with IS on pulmonary function test (PFT) parameters, dyspnea levels, cough effectiveness, and sputum characteristics in patients with cervical SCI undergoing inpatient rehabilitation. The study also aims to compare outcomes between an intervention group receiving incentive spirometry and a control group receiving conventional physiotherapy. This randomized controlled trial will include patients aged 18 to 65 years with cervical SCI (C4-C7), disease duration less than one year, and the ability to give informed consent. Participants will be randomly divided into two groups. Group A (intervention group) will perform nasal resistance breathing exercises with incentive spirometer for 20 minutes daily 3 time, five times per week, over a period of four weeks. Group B (control group) will receive conventional respiratory physiotherapy three time per week over a period of four weeks without the device. Baseline and post-intervention (week 4) data will be collected using pulmonary function tests (PFTs), a dyspnea scale (modified Borg), cough (Cough frequency scale) and sputum grading questionnaire. Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p < 0.05. The data will be analyzed using SPSS v 25.
- Being tested
- Acapella device plus Incentive Spirometry, conventional respiratory physiotherapy
- Keywords
- Cervical cord injury, Dyspnea, Incentive spirometer, Low volume nose resistance breathing exercise
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella device plus Incentive SpirometryDevice
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
conventional respiratory physiotherapyBehavioural
exercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision
| Study group | Role | What they receive |
|---|---|---|
| Low Volume Nose Resistance Breathing Exercises (LVNRBE) | Experimental | Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks Receives: Device: Acapella device plus Incentive Spirometry |
| conventional respiratory physiotherapy | Active comparator | (Control): Receives conventional respiratory physiotherapy with the same frequency and duration. Receives: Behavioral: conventional respiratory physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Modified Borg Dyspnea Scale
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
Measured: 5 weeks
Secondary outcomes (2)
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.
Measured: 5 weeks
Sputum Grading Scale.
This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 May 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645027
- Sponsor's protocol ID
- REC/RCR & AHS/25/0305
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Volume Nose Resistance Breathing Exercise With Incentive Spirometer on Pulmonary Function Test, Dyspnea, Cough and Sputum in Patient With Cervical Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT07645027
- Acronym / sponsor ID
- REC/RCR & AHS/25/0305
- Keywords
- Cervical cord injury, Dyspnea, Incentive spirometer, Low volume nose resistance breathing exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal cord injuries (SCI), particularly at the cervical level, often lead to compromised respiratory function due to partial or complete paralysis of respiratory muscles. This impairment significantly affects pulmonary function, increases dyspnea, and reduces overall quality of life. Respiratory complications remain one of the leading causes of morbidity in individuals with cervical SCI.
Various therapeutic approaches, including breathing exercises and assistive devices, have been used to enhance pulmonary rehabilitation. Pulmonary rehabilitation strategies, including breathing exercises and incentive spirometry, are essential in improving respiratory function in this population.
These techniques help enhance lung expansion, improve airway clearance, and reduce the risk of pulmonary complications, thereby supporting better respiratory health and functional outcomes The primary objective of this study is to evaluate the effect of LVNRBE combined with IS on pulmonary function test (PFT) parameters, dyspnea levels, cough effectiveness, and sputum characteristics in patients with cervical SCI undergoing inpatient rehabilitation. The study also aims to compare outcomes between an intervention group receiving incentive spirometry and a control group receiving conventional physiotherapy. This randomized controlled trial will include patients aged 18 to 65 years with cervical SCI (C4-C7), disease duration less than one year, and the ability to give informed consent. Participants will be randomly divided into two groups. Group A (intervention group) will perform nasal resistance breathing exercises with incentive spirometer for 20 minutes daily 3 time, five times per week, over a period of four weeks. Group B (control group) will receive conventional respiratory physiotherapy three time per week over a period of four weeks without the device. Baseline and post-intervention (week 4) data will be collected using pulmonary function tests (PFTs), a dyspnea scale (modified Borg), cough (Cough frequency scale) and sputum grading questionnaire. Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p < 0.05. The data will be analyzed using SPSS v 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Volume Nose Resistance Breathing Exercises (LVNRBE) | Experimental | Device: Acapella device plus Incentive SpirometryReceives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks |
| conventional respiratory physiotherapy | Active comparator | Behavioral: conventional respiratory physiotherapy(Control): Receives conventional respiratory physiotherapy with the same frequency and duration. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagonosed cervical spine injury C4-C7
- Age 18-38 years
- Undergoing in-patient rehabilitation
- No previous history of severe pulmonary disease
- Disease duration <1 year
Key exclusion criteria (5 listed)
- Uncontrolled hypertension
- Other Neuromuscular disease
- Stage 3-4 pressure wound
- Clinical instability
- Traumatic Brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acapella device plus Incentive SpirometryPFTs 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 | Device | Low Volume Nose Resistance Breathing Exercises (LVNRBE) |
| conventional respiratory physiotherapyexercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision | Behavioural | conventional respiratory physiotherapy |
Primary outcome
Pulmonary Function Tests (FVC, FEV1),
Time frame: 5 weeks
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
Time frame: 5 weeks
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
2 secondary outcomes
Cough Frequency Scale
Time frame: 5 weeks
Sputum Grading Scale.
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjumand Bano, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella device plus Incentive Spirometry and conventional respiratory physiotherapy in people with Cervical Spinal Cord Injury and Cervical Cord Injuries Spinal, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Iqbal Tariq, Phd (333826752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Tests (FVC, FEV1), (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.