- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04741126
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury
December 13, 2021 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Paraplegic center Peshawar.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- The patient with upper cervical,
- thoracic, and
- lumbar spine injury,
- diagnosed with TB,
- degenerative diseases,
- surgical conditions, and
- complete spinal cord injury.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Protocol
Hospital-based manually assisted cough technique for 4 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary functions
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Beauchamp 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.
- Brown 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
February 2, 2021
First Submitted That Met QC Criteria
February 4, 2021
First Posted (Actual)
February 5, 2021
Study Record Updates
Last Update Posted (Actual)
December 15, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rec/00782 Nadeem Ahmad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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