NCT04741126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

February 2, 2021

Last Update Submit

December 13, 2021

Conditions

Spinal Cord Injuries

Keywords

Manually assisted cough techniquePeak cough flowPulmonary functionSpinal cord injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • Pulmonary functions

    4 weeks

Study Arms (1)

Intervention Protocol

EXPERIMENTAL

Hospital-based manually assisted cough technique for 4 weeks.

Other: Manually assisted cough technique

Interventions

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.

Intervention Protocol

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • The patient with upper cervical,
  • thoracic, and
  • lumbar spine injury,
  • diagnosed with TB,
  • degenerative diseases,
  • surgical conditions, and
  • complete spinal cord injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paraplegic center Peshawar.

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • 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.

    PMID: 22453774BACKGROUND

  • 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.

    PMID: 19996334BACKGROUND

  • 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.

    PMID: 16867197BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

November 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

December 15, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)