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Manually Assisted Cough Technique and Incomplete Cervical Spine Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04741126
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : December 15, 2021
Information provided by (Responsible Party):
Riphah International University

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 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.

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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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04741126

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Paraplegic center Peshawar.
Peshawar, KPK, Pakistan, 25000
Sponsors and Collaborators
Riphah International University
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Principal Investigator: Mehwish Waseem, MSPT(CPPT) Riphah International University
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Responsible Party: Riphah International University Identifier: NCT04741126    
Other Study ID Numbers: Rec/00782 Nadeem Ahmad
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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