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Manually Assisted Cough Technique and Incomplete Cervical Spine Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manually assisted cough technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Manually assisted cough technique, Peak cough flow, Pulmonary function, Spinal cord injury

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Paraplegic center Peshawar.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Protocol

Arm Description

Hospital-based manually assisted cough technique for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2021
Last Updated
December 13, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04741126
Brief Title
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury
Official Title
Effectiveness of the Manually Assisted Cough Technique on Peak Coughs Flow and Pulmonary Functions in Patients With Incomplete Cervical Spine Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Manually assisted cough technique, Peak cough flow, Pulmonary function, Spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Protocol
Arm Type
Experimental
Arm Description
Hospital-based manually assisted cough technique for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Manually assisted cough technique
Intervention Description
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 Measure Information:
Title
Peak cough flow
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pulmonary functions
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paraplegic center Peshawar.
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
22453774
Citation
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.
Results Reference
background
PubMed Identifier
19996334
Citation
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.
Results Reference
background
PubMed Identifier
16867197
Citation
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.
Results Reference
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Manually Assisted Cough Technique and Incomplete Cervical Spine Injury

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