Spinal Cord InjuriesNCT04741126
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury
A study testing Manually assisted cough technique in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. Previous studies were designed to target only a small sample. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Manually assisted cough technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient with incomplete cervical spine injury at C4, C5,
- bronchitis,
- shortness of breath having Peak cough flow (PCF) less than 50% and
- ASIA impairment scale C \&D
Who cannot join
- The patient with upper cervical,
- thoracic, and
- lumbar spine injury,
- diagnosed with TB,
- degenerative diseases,
- surgical conditions, and
- complete spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Manually Assisted Cough Technique on Peak Coughs Flow and Pulmonary Functions in Patients With Incomplete Cervical Spine Injury
To determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. Previous studies were designed to target only a small sample. Level and American Spinal Cord Injury Association (ASIA) scale were not specified so this study covers this aspect.
Read the detailed description
The previous studies show that the partial control of the muscle necessary for cough, which varies with motor level, proportionately improves the patient's ability to cough volitionally. Spinal cord injury also affects mucus clearance, the peak flow meter was used to assist the ability of cough and they also measure the peak cough flow (PFC).In the literature for the airway clearance, the following techniques were used, incentive spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure. There is increasing interest in strategies such as interval training that may provide a tolerable training load while maintaining an effective stimulus for adaptation. Manually assisted cough technique is used to enhance the cough strength, to help with mucus secretion it can be carried out in lying, side-lying, or sitting positions.it is important that clear secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection and complication can be reduced which improve the quality of life. Manually assisted cough is a technique using strong arms to assist cough. This may be providing help in neuromuscular disease or spinal cord injury with weak respiratory and abdominal muscle.
- Conditions
- Spinal Cord Injuries
- Being tested
- Manually assisted cough technique
- Keywords
- Manually assisted cough technique, Peak cough flow, Pulmonary function, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manually assisted cough techniqueOther
Manually assisted cough technique will be given for four weeks. 10 to 12 repetitions of manually assisted cough technique with rest will be given in one minute 3 to 4 time of repetition in a 1 set. The result of the peak cough flow meter and incentive spirometer will be check pre and post only.3 sets will be given in one session and 2-time session will be recommended per day. The session will be given three days in a week. The Result of the Peak Cough flow meter and incentive spirometer will be check pre and post only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Protocol | Experimental | Hospital-based manually assisted cough technique for 4 weeks. Receives: Other: Manually assisted cough technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cough flow
Changes from the baseline will be measured after 4 weeks through a small, hand-held device which is used to monitor a person's ability to breathe out air. It measures the airflow through the bronchi of the lungs and thus indicates the degree of obstruction in the airways. Peak flow readings are higher health airways and decreases in obstructive airways.
Measured: 4 weeks
Secondary outcomes (1)
Pulmonary functions
Changes from the baseline will be measured after 4 weeks through the incentive spirometer. This device will measure how deeply patient can inhale (breathe in) and to evaluate the volumes and capacities of the patient before and after intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Nov 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741126
- Sponsor's protocol ID
- Rec/00782 Nadeem Ahmad
- Status last verified
- Dec 2021
- First submitted
- 2 Feb 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parmar K, Gunjal SB. Effectiveness of Manually Assisted Cough Technique on Peak Cough Flow in Patients with Spinal Cord Injury. Int J Res Rev. 2020;7(2):243-8.
Choi WA, Park JH, Kim DH, Kang SW. Cough assistance device for patients with glottis dysfunction and/or tracheostomy. J Rehabil Med. 2012 Apr;44(4):351-4. doi: 10.2340/16501977-0948.
PubMed 22453774Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.
PubMed 19996334Brown R, DiMarco AF, Hoit JD, Garshick E. Respiratory dysfunction and management in spinal cord injury. Respir Care. 2006 Aug;51(8):853-68;discussion 869-70.
PubMed 16867197
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Manually Assisted Cough Technique on Peak Coughs Flow and Pulmonary Functions in Patients With Incomplete Cervical Spine Injury
- ClinicalTrials.gov ID
- NCT04741126
- Acronym / sponsor ID
- Rec/00782 Nadeem Ahmad
- Conditions
- Spinal Cord Injuries
- Keywords
- Manually assisted cough technique, Peak cough flow, Pulmonary function, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 Feb 2021 (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.
To determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. Previous studies were designed to target only a small sample. Level and American Spinal Cord Injury Association (ASIA) scale were not specified so this study covers this aspect.
Detailed description
The previous studies show that the partial control of the muscle necessary for cough, which varies with motor level, proportionately improves the patient's ability to cough volitionally. Spinal cord injury also affects mucus clearance, the peak flow meter was used to assist the ability of cough and they also measure the peak cough flow (PFC).In the literature for the airway clearance, the following techniques were used, incentive spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure. There is increasing interest in strategies such as interval training that may provide a tolerable training load while maintaining an effective stimulus for adaptation. Manually assisted cough technique is used to enhance the cough strength, to help with mucus secretion it can be carried out in lying, side-lying, or sitting positions.it is important that clear secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection and complication can be reduced which improve the quality of life. Manually assisted cough is a technique using strong arms to assist cough. This may be providing help in neuromuscular disease or spinal cord injury with weak respiratory and abdominal muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Protocol | Experimental | Other: Manually assisted cough techniqueHospital-based manually assisted cough technique for 4 weeks. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient with incomplete cervical spine injury at C4, C5,
- bronchitis,
- shortness of breath having Peak cough flow (PCF) less than 50% and
- ASIA impairment scale C \&D
Key exclusion criteria (7 listed)
- The patient with upper cervical,
- thoracic, and
- lumbar spine injury,
- diagnosed with TB,
- degenerative diseases,
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 |
|---|---|---|
| Manually assisted cough techniqueManually assisted cough technique will be given for four weeks. 10 to 12 repetitions of manually assisted cough technique with rest will be given in one minute 3 to 4 time of repetition in a 1 set. The result of the peak cough flow meter and incentive spirometer will be check pre and post only.3 sets will be given in one session and 2-time session will be recommended per day. The session will be given three days in a week. The Result of the Peak Cough flow meter and incentive spirometer will be check pre and post only. | Other | Intervention Protocol |
Primary outcome
Peak cough flow
Time frame: 4 weeks
Changes from the baseline will be measured after 4 weeks through a small, hand-held device which is used to monitor a person's ability to breathe out air. It measures the airflow through the bronchi of the lungs and thus indicates the degree of obstruction in the airways. Peak flow readings are higher health airways and decreases in obstructive airways.
1 secondary outcome
Pulmonary functions
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- BackgroundParmar K, Gunjal SB. Effectiveness of Manually Assisted Cough Technique on Peak Cough Flow in Patients with Spinal Cord Injury. Int J Res Rev. 2020;7(2):243-8.
- Background: PubMed 22453774Choi WA, Park JH, Kim DH, Kang SW. Cough assistance device for patients with glottis dysfunction and/or tracheostomy. J Rehabil Med. 2012 Apr;44(4):351-4. doi: 10.2340/16501977-0948.
- Background: PubMed 19996334Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.
- Background: PubMed 16867197Brown R, DiMarco AF, Hoit JD, Garshick E. Respiratory dysfunction and management in spinal cord injury. Respir Care. 2006 Aug;51(8):853-68;discussion 869-70.
- 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. This study is not recruiting at the moment.
Mehwish Waseem, MSPT(CPPT) 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 Manually assisted cough technique in people with Spinal Cord Injuries, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 15 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak cough flow (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741126, which also lists 4 linked publications.
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 15 Dec 2021.