Manually Assisted Cough Technique and Incomplete Cervical Spine Injury

• ClinicalTrials.gov Identifier: NCT04741126
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: December 15, 2021
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Study Description

Brief 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. Level and American Spinal Cord Injury Association (ASIA) scale were not specified so this study covers this aspect.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Other: Manually assisted cough technique	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of the Manually Assisted Cough Technique on Peak Coughs Flow and Pulmonary Functions in Patients With Incomplete Cervical Spine Injury
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: August 1, 2021
• Actual Study Completion Date: August 1, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention Protocol; Hospital-based manually assisted cough technique for 4 weeks.

Other: Manually assisted cough technique; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Pakistan

Paraplegic center Peshawar.

Peshawar, KPK, Pakistan, 25000

Sponsors and Collaborators

Riphah International University

Investigators

• Principal Investigator: Mehwish Waseem, MSPT(CPPT); Riphah International University

More Information

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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT04741126
• Other Study ID Numbers: Rec/00782 Nadeem Ahmad
• First Posted: February 5, 2021
• Last Update Posted: December 15, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riphah International University:

Manually assisted cough technique; Peak cough flow; Pulmonary function; Spinal cord injury

Additional relevant MeSH terms:

Cough; Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory